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Trial record 44 of 190 for:    Oral Cancer | ( Map: Mexico )

A Study of Neoadjuvant Letrozole + Taselisib Versus Letrozole + Placebo in Post-Menopausal Women With Breast Cancer (LORELEI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02273973
Recruitment Status : Completed
First Posted : October 24, 2014
Results First Posted : May 21, 2018
Last Update Posted : May 21, 2018
Sponsor:
Collaborators:
SOLTI Breast Cancer Research Group
Breast International Group
Austrian Breast and Colorectal Cancer Group
Information provided by (Responsible Party):
Genentech, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Drug: Letrozole
Other: Placebo
Drug: Taselisib
Enrollment 334
Recruitment Details The study recruited post-menopausal participants with breast cancer in 22 countries from November 2014 to March 2017.
Pre-assignment Details  
Arm/Group Title Experimental: Taselisib + Letrozole Placebo Comparator: Placebo + Letrozole
Hide Arm/Group Description Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks. Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
Period Title: Overall Study
Started 166 168
Completed 157 160
Not Completed 9 8
Reason Not Completed
Adverse Event             4             0
Withdrawal by Subject             2             3
Death             1             0
Non-compliance             1             0
Protocol Violation             1             0
Progression of disease             0             2
Lost to Follow-up             0             1
Physician Decision             0             1
Reason not specified             0             1
Arm/Group Title Experimental: Taselisib + Letrozole Placebo Comparator: Placebo + Letrozole Total
Hide Arm/Group Description Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks. Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks. Total of all reporting groups
Overall Number of Baseline Participants 166 168 334
Hide Baseline Analysis Population Description
Intention-to-Treat (ITT) population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 166 participants 168 participants 334 participants
64.6  (8.5) 64.7  (8.7) 64.6  (8.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 166 participants 168 participants 334 participants
Female
166
 100.0%
168
 100.0%
334
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 166 participants 168 participants 334 participants
White
143
  86.1%
140
  83.3%
283
  84.7%
American Indian or Alaskan Native
11
   6.6%
11
   6.5%
22
   6.6%
Asian
6
   3.6%
6
   3.6%
12
   3.6%
Black or African American
1
   0.6%
5
   3.0%
6
   1.8%
Multiple
1
   0.6%
0
   0.0%
1
   0.3%
Other
3
   1.8%
6
   3.6%
9
   2.7%
Missing
1
   0.6%
0
   0.0%
1
   0.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 166 participants 168 participants 334 participants
Hispanic or Latino
36
  21.7%
48
  28.6%
84
  25.1%
Not Hispanic or Latino
114
  68.7%
109
  64.9%
223
  66.8%
Not Reported
13
   7.8%
10
   6.0%
23
   6.9%
Unknown
3
   1.8%
1
   0.6%
4
   1.2%
1.Primary Outcome
Title Percentage of Participants With Objective Response (OR) by Centrally Assessed Breast Magnetic Resonance Imaging (MRI) Via Modified Response Evaluation Criteria in Solid Tumors (mRECIST) Version 1.1
Hide Description Objective response rate (ORR) was defined as proportion of participants achieving complete response (CR) or partial response (PR). As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Time Frame From Baseline to 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).
Arm/Group Title Experimental: Taselisib + Letrozole Placebo Comparator: Placebo + Letrozole
Hide Arm/Group Description:
Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
Overall Number of Participants Analyzed 166 168
Measure Type: Number
Unit of Measure: percentage of participants
50.0 39.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Experimental: Taselisib + Letrozole, Placebo Comparator: Placebo + Letrozole
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0490
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Response Rates
Estimated Value 10.71
Confidence Interval (2-Sided) 95%
0.11 to 21.32
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percentage of Participants With Total Pathologic Complete Response (Total pCR), Defined as Having pCR in Both Breast and Axilla, Using American Joint Committee on Cancer (AJCC) Staging System
Hide Description Total pCR was assessed by local pathology review on samples taken at surgery following completion of neoadjuvant therapy. tpCR was defined as the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes ( i.e., ypT0/Tis, ypN0 in the AJCC staging system, 7th edition).
Time Frame From Baseline to 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).
Arm/Group Title Experimental: Taselisib + Letrozole Placebo Comparator: Placebo + Letrozole
Hide Arm/Group Description:
Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
Overall Number of Participants Analyzed 166 168
Measure Type: Number
Unit of Measure: percentage of participants
1.8 0.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Experimental: Taselisib + Letrozole, Placebo Comparator: Placebo + Letrozole
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3698
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Response Rates
Estimated Value 1.21
Confidence Interval (2-Sided) 95%
-1.12 to 3.55
Estimation Comments [Not Specified]
3.Primary Outcome
Title Percentage of Participants With OR by Centrally Assessed Breast MRI Via mRECIST Version 1.1 in Phosphatidylinositol-4,5-Bisphosphate 3-Kinase, Catalytic Subunit Alpha (PIK3CA) Mutant (MT) Participants
Hide Description ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Time Frame From Baseline to 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).
Arm/Group Title Experimental: Taselisib + Letrozole Placebo Comparator: Placebo + Letrozole
Hide Arm/Group Description:
Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
Overall Number of Participants Analyzed 73 79
Measure Type: Number
Unit of Measure: percentage of participants
56.2 38.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Experimental: Taselisib + Letrozole, Placebo Comparator: Placebo + Letrozole
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0332
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Response Rates
Estimated Value 18.19
Confidence Interval (2-Sided) 95%
2.57 to 33.81
Estimation Comments [Not Specified]
4.Primary Outcome
Title Percentage of Participants With Total pCR , Defined as Having pCR in Both Breast and Axilla, Using AJCC Staging System in PIK3CA MT Participants
Hide Description Total pCR was assessed by local pathology review on samples taken at surgery following completion of neoadjuvant therapy. tpCR was defined as the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes (i.e., ypT0/Tis, ypN0 in the AJCC staging system, 7th edition).
Time Frame From Baseline to 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).
Arm/Group Title Experimental: Taselisib + Letrozole Placebo Comparator: Placebo + Letrozole
Hide Arm/Group Description:
Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
Overall Number of Participants Analyzed 73 79
Measure Type: Number
Unit of Measure: percentage of participants
1.4 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Experimental: Taselisib + Letrozole, Placebo Comparator: Placebo + Letrozole
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4803
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Response Rates
Estimated Value 1.37
Confidence Interval (2-Sided) 95%
-1.30 to 4.04
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants With OR by Centrally Assessed Breast MRI Via mRECIST Version 1.1 in PIK3CA Wildtype (WT) Participants
Hide Description ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Time Frame From Baseline to 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).
Arm/Group Title Experimental: Taselisib + Letrozole Placebo Comparator: Placebo + Letrozole
Hide Arm/Group Description:
Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
Overall Number of Participants Analyzed 92 89
Measure Type: Number
Unit of Measure: percentage of participants
45.7 40.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Experimental: Taselisib + Letrozole, Placebo Comparator: Placebo + Letrozole
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5017
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Response Rates
Estimated Value 5.20
Confidence Interval (2-Sided) 95%
-9.20 to 19.61
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants With Total pCR Defined as Having pCR in Both Breast and Axilla, Using AJCC Staging System in PIK3CA WT Participants
Hide Description Total pCR was assessed by local pathology review on samples taken at surgery following completion of neoadjuvant therapy. tpCR was defined as the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes (i.e., ypT0/Tis, ypN0 in the AJCC staging system, 7th edition).
Time Frame From Baseline to 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).
Arm/Group Title Experimental: Taselisib + Letrozole Placebo Comparator: Placebo + Letrozole
Hide Arm/Group Description:
Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
Overall Number of Participants Analyzed 92 89
Measure Type: Number
Unit of Measure: percentage of participants
2.2 1.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Experimental: Taselisib + Letrozole, Placebo Comparator: Placebo + Letrozole
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Response Rates
Estimated Value 1.05
Confidence Interval (2-Sided) 95%
-2.65 to 4.75
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Participants With OR by Breast Ultrasound Via mRECIST Version 1.1 in PIK3CA MT Participants
Hide Description ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Time Frame From Baseline to 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).
Arm/Group Title Experimental: Taselisib + Letrozole Placebo Comparator: Placebo + Letrozole
Hide Arm/Group Description:
Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
Overall Number of Participants Analyzed 73 79
Measure Type: Number
Unit of Measure: percentage of participants
61.6 40.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Experimental: Taselisib + Letrozole, Placebo Comparator: Placebo + Letrozole
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0115
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Response Rates
Estimated Value 21.14
Confidence Interval (2-Sided) 95%
5.59 to 36.68
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Percentage of Participants With OR by Breast Ultrasound Via mRECIST Version 1.1 in PIK3CA WT Participants
Hide Description ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Time Frame From Baseline to 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).
Arm/Group Title Experimental: Taselisib + Letrozole Placebo Comparator: Placebo + Letrozole
Hide Arm/Group Description:
Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
Overall Number of Participants Analyzed 92 89
Measure Type: Number
Unit of Measure: percentage of participants
54.3 51.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Experimental: Taselisib + Letrozole, Placebo Comparator: Placebo + Letrozole
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7928
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Response Rates
Estimated Value 2.66
Confidence Interval (2-Sided) 95%
-11.88 to 17.20
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Percentage of Participants With OR by Mammography Via mRECIST Version 1.1 in PIK3CA MT Participants
Hide Description ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Time Frame From Baseline to 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).
Arm/Group Title Experimental: Taselisib + Letrozole Placebo Comparator: Placebo + Letrozole
Hide Arm/Group Description:
Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
Overall Number of Participants Analyzed 73 79
Measure Type: Number
Unit of Measure: percentage of participants
41.1 31.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Experimental: Taselisib + Letrozole, Placebo Comparator: Placebo + Letrozole
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2659
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Response Rates
Estimated Value 9.45
Confidence Interval (2-Sided) 95%
-5.80 to 24.70
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Percentage of Participants With OR by Mammography Via mRECIST Version 1.1 in PIK3CA WT Participants
Hide Description ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Time Frame From Baseline to 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).
Arm/Group Title Experimental: Taselisib + Letrozole Placebo Comparator: Placebo + Letrozole
Hide Arm/Group Description:
Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
Overall Number of Participants Analyzed 92 89
Measure Type: Number
Unit of Measure: percentage of participants
40.2 32.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Experimental: Taselisib + Letrozole, Placebo Comparator: Placebo + Letrozole
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3299
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Response Rates
Estimated Value 7.63
Confidence Interval (2-Sided) 95%
-6.34 to 21.60
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Percentage of Participants With OR by Clinical Breast Exam (Palpation) Via mRECIST Version 1.1 in PIK3CA MT Participants
Hide Description ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Time Frame From Baseline to 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).
Arm/Group Title Experimental: Taselisib + Letrozole Placebo Comparator: Placebo + Letrozole
Hide Arm/Group Description:
Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
Overall Number of Participants Analyzed 73 79
Measure Type: Number
Unit of Measure: percentage of participants
74.0 63.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Experimental: Taselisib + Letrozole, Placebo Comparator: Placebo + Letrozole
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1554
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Response Rates
Estimated Value 10.68
Confidence Interval (2-Sided) 95%
-3.96 to 25.32
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Percentage of Participants With OR by Clinical Breast Exam (Palpation) Via mRECIST Version 1.1 in PIK3CA WT Participants
Hide Description ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Time Frame From Baseline to 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).
Arm/Group Title Experimental: Taselisib + Letrozole Placebo Comparator: Placebo + Letrozole
Hide Arm/Group Description:
Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
Overall Number of Participants Analyzed 92 89
Measure Type: Number
Unit of Measure: percentage of participants
62.0 59.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Experimental: Taselisib + Letrozole, Placebo Comparator: Placebo + Letrozole
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7870
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Response Rates
Estimated Value 2.41
Confidence Interval (2-Sided) 95%
-11.82 to 16.63
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Central Assessments of Changes in Ki67 Levels
Hide Description Ki67 is a prognostic marker and is used to evaluate the proliferative activity of breast cancer.
Time Frame From Baseline to Week 3 and Surgery (Weeks 17-18); and Week 3 to Surgery (Weeks 17-18)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).
Arm/Group Title Experimental: Taselisib + Letrozole Placebo Comparator: Placebo + Letrozole
Hide Arm/Group Description:
Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
Overall Number of Participants Analyzed 166 168
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage
From Baseline to Week 3
-83.81
(-86.73 to -80.23)
-80.44
(-83.93 to -76.19)
From Baseline to Surgery
-75.58
(-80.45 to -69.49)
-80.51
(-84.41 to -75.64)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Experimental: Taselisib + Letrozole, Placebo Comparator: Placebo + Letrozole
Comments Statistical analysis for changes in Ki67 levels from Baseline to Week 3.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.117
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Least square mean
Estimated Value 0.83
Confidence Interval (2-Sided) 95%
0.65 to 1.05
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Experimental: Taselisib + Letrozole, Placebo Comparator: Placebo + Letrozole
Comments Statistical analysis for changes in Ki67 levels from Baseline to Surgery.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.105
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Least square mean
Estimated Value 1.25
Confidence Interval (2-Sided) 95%
0.95 to 1.65
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Preoperative Endocrine Prognostic Index (PEPI ) Score
Hide Description To obtain the PEPI score, risk points for relapse-free survival (RFS) and breast cancer-specific survival (BCSS) are assigned depending on the hazard ratio (HR) from the multivariable analysis. The total PEPI score assigned to each participant is the sum of the risk points derived from the primary tumor (pT) stage, regional lymph nodes (pN) stage, Ki67 level, and estrogen receptor status of the surgical specimen. A HR in the range of 1 to 2 receives one risk point; a HR in the 2 to 2.5 range, two risk points; a HR greater than 2.5, three risk points. The total risk point score for each participant is the sum of all the risk points accumulated from the four factors in the model, ranges from 0 (best possible outcome) to 12 (worst possible outcome).
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected for this outcome measure.
Arm/Group Title Experimental: Taselisib + Letrozole Placebo Comparator: Placebo + Letrozole
Hide Arm/Group Description:
Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
15.Secondary Outcome
Title Percent Change From Baseline to Surgery in Enhancing Tumor Volume as Measured by Breast MRI
Hide Description [Not Specified]
Time Frame From Baseline to Surgery (Weeks 17-18)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).
Arm/Group Title Experimental: Taselisib + Letrozole Placebo Comparator: Placebo + Letrozole
Hide Arm/Group Description:
Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
Overall Number of Participants Analyzed 166 168
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent change
-70.60
(-77.53 to -63.66)
-57.28
(-64.21 to -50.35)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Experimental: Taselisib + Letrozole, Placebo Comparator: Placebo + Letrozole
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value -13.32
Confidence Interval (2-Sided) 95%
-21.67 to -4.96
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Hide Description EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall quality of life (QOL) in cancer participants. The first 28 questions used a 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea and vomiting [N/V], constipation, and pain) and a single item (financial difficulties). The last 2 questions represented the participant’s assessment of overall health and quality of life, used 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 global scores were linearly transformed on a scale of 0 to 100, with a high score indicating better QOL. Negative change from Baseline values indicated deterioration in QOL or functioning and positive values indicated improvement. Here, Post surgery= PS.
Time Frame Weeks 1, 5, 9, 13, 16, 4-week Post-Surgery
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).
Arm/Group Title Experimental: Taselisib + Letrozole Placebo Comparator: Placebo + Letrozole
Hide Arm/Group Description:
Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
Overall Number of Participants Analyzed 166 168
Mean (Standard Deviation)
Unit of Measure: score on a scale
Appetite Loss: Baseline Number Analyzed 157 participants 165 participants
6.2  (16.4) 5.9  (14.2)
Appetite Loss: Change at Week 5 Number Analyzed 155 participants 160 participants
3.0  (18.4) 1.9  (18.8)
Appetite Loss: Change at Week 9 Number Analyzed 152 participants 158 participants
5.3  (21.4) 3.0  (17.8)
Appetite Loss: Change at Week 13 Number Analyzed 152 participants 157 participants
5.5  (23.8) 2.1  (16.3)
Appetite Loss: Change at Week 16 Number Analyzed 146 participants 151 participants
6.8  (24.1) 0.9  (16.3)
Appetite Loss: Change at PS Visit Number Analyzed 140 participants 146 participants
5.0  (24.9) 5.0  (23.3)
Cognitive functioning: Baseline Number Analyzed 158 participants 163 participants
90.8  (15.8) 90.9  (16.6)
Cognitive functioning: Change at Week 5 Number Analyzed 154 participants 157 participants
0.4  (12.8) -2.5  (12.3)
Cognitive functioning: Change at Week 9 Number Analyzed 151 participants 157 participants
-1.1  (14.4) -4.2  (14.7)
Cognitive functioning: Change at Week 13 Number Analyzed 153 participants 156 participants
-3.4  (15.8) -5.1  (15.7)
Cognitive functioning: Change at Week 16 Number Analyzed 147 participants 147 participants
-4.2  (15.2) -4.1  (17.5)
Cognitive functioning: Change at PS Visit Number Analyzed 140 participants 144 participants
-3.1  (18.9) -5.4  (16.8)
Constipation: Baseline Number Analyzed 158 participants 164 participants
6.8  (15.9) 8.3  (18.2)
Constipation: Change at Week 5 Number Analyzed 155 participants 159 participants
0.0  (16.1) 3.1  (22.1)
Constipation: Change at Week 9 Number Analyzed 151 participants 158 participants
0.2  (17.0) 0.2  (18.6)
Constipation: Change at Week 13 Number Analyzed 151 participants 156 participants
-0.4  (18.5) -0.6  (19.5)
Constipation: Change at Week 16 Number Analyzed 146 participants 148 participants
-1.1  (17.2) 1.6  (20.3)
Constipation: Change at PS Visit Number Analyzed 140 participants 145 participants
4.8  (23.2) 1.1  (16.9)
Diarrhoea: Baseline Number Analyzed 157 participants 163 participants
5.9  (14.9) 4.3  (11.8)
Diarrhoea: Change at Week 5 Number Analyzed 154 participants 155 participants
6.7  (21.7) -0.2  (13.4)
Diarrhoea: Change at Week 9 Number Analyzed 150 participants 157 participants
6.4  (24.3) 0.8  (15.1)
Diarrhoea: Change at Week 13 Number Analyzed 152 participants 155 participants
7.9  (22.3) -0.4  (14.7)
Diarrhoea: Change at Week 16 Number Analyzed 146 participants 146 participants
8.4  (23.1) 0.2  (16.4)
Diarrhoea: Change at PS Visit Number Analyzed 140 participants 144 participants
0.2  (17.7) -0.9  (15.7)
Dyspnoea: Baseline Number Analyzed 157 participants 165 participants
7.4  (15.8) 8.5  (17.5)
Dyspnoea: Change at Week 5 Number Analyzed 154 participants 160 participants
-0.2  (14.0) 0.6  (18.1)
Dyspnoea: Change at Week 9 Number Analyzed 150 participants 159 participants
2.0  (17.4) 1.9  (19.9)
Dyspnoea: Change at Week 13 Number Analyzed 151 participants 157 participants
3.5  (21.1) 1.7  (22.3)
Dyspnoea: Change at Week 16 Number Analyzed 146 participants 151 participants
3.4  (20.2) 2.6  (22.6)
Dyspnoea: Change at PS Visit Number Analyzed 138 participants 146 participants
3.1  (24.8) 2.1  (21.5)
Emotional functioning: Baseline Number Analyzed 158 participants 163 participants
77.0  (20.4) 78.2  (19.9)
Emotional functioning: Change at Week 5 Number Analyzed 154 participants 157 participants
4.2  (15.2) 2.4  (17.0)
Emotional functioning: Change at Week 9 Number Analyzed 151 participants 157 participants
3.8  (14.7) 1.3  (20.7)
Emotional functioning: Change at Week 13 Number Analyzed 153 participants 156 participants
2.5  (15.2) -1.4  (18.6)
Emotional functioning: Change at Week 16 Number Analyzed 147 participants 147 participants
1.0  (17.0) -3.5  (20.2)
Emotional functioning: Change at PS Visit Number Analyzed 140 participants 144 participants
-0.8  (19.0) -3.6  (20.9)
Fatigue: Baseline Number Analyzed 158 participants 165 participants
14.8  (18.7) 15.6  (18.5)
Fatigue: Change at Week 5 Number Analyzed 155 participants 161 participants
4.7  (13.9) 4.9  (17.9)
Fatigue: Change at Week 9 Number Analyzed 152 participants 159 participants
5.0  (15.9) 7.5  (20.3)
Fatigue: Change at Week 13 Number Analyzed 151 participants 158 participants
7.9  (18.1) 8.8  (21.4)
Fatigue: Change at Week 16 Number Analyzed 146 participants 151 participants
6.8  (17.5) 8.0  (20.4)
Fatigue: Change at PS Visit Number Analyzed 140 participants 146 participants
12.3  (19.5) 12.4  (22.6)
Financial difficulties: Baseline Number Analyzed 156 participants 160 participants
9.0  (20.9) 10.0  (20.4)
Financial difficulties: Change at Week 5 Number Analyzed 152 participants 154 participants
-2.6  (14.6) -0.4  (20.2)
Financial difficulties: Change at Week 9 Number Analyzed 151 participants 153 participants
-2.6  (17.9) 0.7  (20.4)
Financial difficulties: Change at Week 13 Number Analyzed 150 participants 152 participants
-1.1  (17.9) 0.0  (19.9)
Financial difficulties: Change at Week 16 Number Analyzed 145 participants 144 participants
-1.1  (15.9) 2.1  (24.4)
Financial difficulties: Change at PS Visit Number Analyzed 138 participants 141 participants
1.9  (20.0) 3.8  (23.6)
Global health status / QoL: Baseline Number Analyzed 158 participants 162 participants
75.3  (19.7) 74.6  (21.2)
Global health status / QoL: Change at Week 5 Number Analyzed 153 participants 156 participants
1.5  (15.2) -1.1  (18.5)
Global health status / QoL: Change at Week 9 Number Analyzed 150 participants 155 participants
-1.1  (15.9) -3.2  (22.7)
Global health status / QoL: Change at Week 13 Number Analyzed 152 participants 155 participants
-2.4  (19.5) -3.7  (20.7)
Global health status / QoL: Change at Week 16 Number Analyzed 147 participants 146 participants
-2.2  (18.4) -2.9  (22.6)
Global health status / QoL: Change at PS Visit Number Analyzed 139 participants 143 participants
-5.9  (19.7) -7.0  (22.2)
Insomnia: Baseline Number Analyzed 158 participants 165 participants
23.0  (27.1) 22.4  (28.1)
Insomnia: Change at Week 5 Number Analyzed 155 participants 161 participants
-2.4  (24.1) -0.4  (27.6)
Insomnia: Change at Week 9 Number Analyzed 151 participants 159 participants
-1.8  (24.9) -0.6  (26.9)
Insomnia: Change at Week 13 Number Analyzed 153 participants 158 participants
-1.1  (27.7) 2.1  (29.5)
Insomnia: Change at Week 16 Number Analyzed 146 participants 149 participants
-0.7  (26.1) -2.2  (27.6)
Insomnia: Change at PS Visit Number Analyzed 140 participants 146 participants
-1.4  (26.8) 3.2  (34.4)
Nausea and vomiting: Baseline Number Analyzed 158 participants 165 participants
1.9  (7.5) 1.6  (6.2)
Nausea and vomiting: Change at Week 5 Number Analyzed 155 participants 161 participants
3.7  (11.3) 1.9  (9.9)
Nausea and vomiting: Change at Week 9 Number Analyzed 152 participants 159 participants
3.4  (10.9) 1.7  (10.3)
Nausea and vomiting: Change at Week 13 Number Analyzed 153 participants 158 participants
3.7  (12.9) 0.7  (8.5)
Nausea and vomiting: Change at Week 16 Number Analyzed 146 participants 151 participants
2.5  (14.0) 0.6  (8.0)
Nausea and vomiting: Change at PS Visit Number Analyzed 140 participants 146 participants
2.1  (14.8) 1.0  (8.6)
Pain: Baseline Number Analyzed 157 participants 165 participants
13.1  (20.4) 12.3  (19.6)
Pain: Change at Week 5 Number Analyzed 155 participants 161 participants
-0.6  (18.8) 2.6  (17.5)
Pain: Change at Week 9 Number Analyzed 152 participants 159 participants
-1.8  (16.5) 3.8  (22.9)
Pain: Change at Week 13 Number Analyzed 152 participants 158 participants
-1.4  (18.4) 4.7  (23.4)
Pain: Change at Week 16 Number Analyzed 147 participants 151 participants
-0.9  (19.1) 1.8  (22.0)
Pain: Change at PS Visit Number Analyzed 140 participants 146 participants
11.1  (26.0) 13.8  (26.6)
Physical functioning: Baseline Number Analyzed 158 participants 165 participants
89.6  (13.7) 90.8  (13.4)
Physical functioning: Change at Week 5 Number Analyzed 155 participants 161 participants
0.5  (9.6) -1.2  (11.5)
Physical functioning: Change at Week 9 Number Analyzed 152 participants 157 participants
0.2  (10.1) -2.0  (13.1)
Physical functioning: Change at Week 13 Number Analyzed 152 participants 158 participants
-0.3  (12.4) -1.9  (14.0)
Physical functioning: Change at Week 16 Number Analyzed 146 participants 150 participants
-0.5  (10.9) -3.4  (15.1)
Physical functioning: Change at PS Visit Number Analyzed 140 participants 146 participants
-5.2  (16.0) -7.5  (15.7)
Role functioning: Baseline Number Analyzed 157 participants 165 participants
90.7  (20.1) 93.1  (16.5)
Role functioning:Change at Week 5 Number Analyzed 155 participants 160 participants
1.3  (14.3) -2.5  (17.1)
Role functioning:Change at Week 9 Number Analyzed 150 participants 159 participants
-0.2  (12.8) -4.9  (18.9)
Role functioning:Change at Week 13 Number Analyzed 152 participants 157 participants
-2.3  (17.4) -5.6  (19.8)
Role functioning:Change at Week 16 Number Analyzed 146 participants 151 participants
-4.6  (16.3) -4.4  (18.9)
Role functioning:Change at PS Visit Number Analyzed 140 participants 146 participants
-15.1  (24.7) -20.1  (28.1)
Social functioning: Baseline Number Analyzed 155 participants 161 participants
91.2  (17.6) 94.9  (14.3)
Social functioning: Change at Week 5 Number Analyzed 151 participants 155 participants
3.1  (12.8) -2.0  (15.7)
Social functioning: Change at Week 9 Number Analyzed 150 participants 155 participants
2.0  (13.4) -4.0  (18.1)
Social functioning: Change at Week 13 Number Analyzed 150 participants 154 participants
0.0  (13.7) -4.0  (19.0)
Social functioning: Change at Week 16 Number Analyzed 146 participants 145 participants
-0.5  (13.7) -3.1  (19.3)
Social functioning: Change at PS Visit Number Analyzed 139 participants 142 participants
-6.4  (20.3) -10.1  (24.2)
17.Secondary Outcome
Title Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23)
Hide Description EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective [FP]) and four symptom scales (systemic side effects [SE], upset by hair loss, arm symptoms, breast symptoms). Questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Scores were averaged and transformed to 0-100 scale. High score for functional scale indicated high/better level of functioning/healthy functioning. Negative change from Baseline indicated deterioration in QOL and positive change from Baseline indicated an improvement in QOL. Here, Post surgery= PS.
Time Frame Weeks 1, 5, 9, 13, 16, 4-week Post-Surgery
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).
Arm/Group Title Experimental: Taselisib + Letrozole Placebo Comparator: Placebo + Letrozole
Hide Arm/Group Description:
Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
Overall Number of Participants Analyzed 166 168
Mean (Standard Deviation)
Unit of Measure: score on a scale
Body image: Baseline Number Analyzed 155 participants 160 participants
91.8  (15.7) 94.0  (14.6)
Body image: Change at Week 5 Number Analyzed 152 participants 151 participants
2.8  (8.8) 0.6  (11.4)
Body image: Change at Week 9 Number Analyzed 149 participants 150 participants
1.2  (9.8) -0.2  (10.3)
Body image: Change at Week 13 Number Analyzed 150 participants 149 participants
1.2  (11.6) -1.6  (13.8)
Body image: Change at Week 16 Number Analyzed 145 participants 143 participants
0.1  (10.8) -1.2  (12.8)
Body image: Change at PS Visit Number Analyzed 138 participants 140 participants
-6.5  (22.3) -8.3  (19.2)
Breast symptoms: Baseline Number Analyzed 154 participants 160 participants
5.3  (9.8) 6.9  (12.7)
Breast symptoms: Change at Week 5 Number Analyzed 148 participants 150 participants
2.3  (14.6) 1.0  (13.0)
Breast symptoms: Change at Week 9 Number Analyzed 148 participants 151 participants
4.5  (15.1) 1.8  (11.7)
Breast symptoms: Change at Week 13 Number Analyzed 149 participants 151 participants
5.8  (16.0) 2.3  (13.3)
Breast symptoms: Change at Week 16 Number Analyzed 146 participants 146 participants
7.9  (18.6) 3.9  (14.9)
Breast symptoms: Change at PS Visit Number Analyzed 136 participants 140 participants
6.6  (17.9) 4.3  (14.2)
Future perspective: Baseline Number Analyzed 157 participants 159 participants
57.7  (31.0) 58.7  (29.9)
Future perspective: Change at Week 5 Number Analyzed 154 participants 151 participants
6.5  (26.7) 9.3  (28.1)
Future perspective: Change at Week 9 Number Analyzed 150 participants 151 participants
10.2  (25.0) 9.7  (26.6)
Future perspective: Change at Week 13 Number Analyzed 151 participants 152 participants
7.7  (28.4) 4.4  (29.1)
Future perspective: Change at Week 16 Number Analyzed 147 participants 145 participants
10.2  (26.1) 5.1  (29.2)
Future perspective: Change at PS Visit Number Analyzed 139 participants 139 participants
6.5  (29.7) 3.4  (34.8)
Sexual enjoyment: Baseline Number Analyzed 48 participants 29 participants
41.7  (22.3) 47.1  (28.9)
Sexual enjoyment: Change at Week 5 Number Analyzed 40 participants 24 participants
3.3  (18.2) 11.1  (23.4)
Sexual enjoyment: Change at Week 9 Number Analyzed 40 participants 22 participants
8.3  (23.6) 10.6  (23.9)
Sexual enjoyment: Change at Week 13 Number Analyzed 33 participants 21 participants
6.1  (19.5) 1.6  (22.3)
Sexual enjoyment: Change at Week 16 Number Analyzed 34 participants 22 participants
9.8  (19.3) 7.6  (22.8)
Sexual enjoyment: Change at PS Visit Number Analyzed 21 participants 15 participants
14.3  (27.0) 2.2  (23.5)
Sexual functioning: Baseline Number Analyzed 149 participants 147 participants
81.2  (23.4) 85.1  (20.2)
Sexual functioning: Change at Week 5 Number Analyzed 144 participants 133 participants
1.2  (13.6) 1.0  (15.0)
Sexual functioning: Change at Week 9 Number Analyzed 136 participants 131 participants
1.3  (14.5) 0.3  (16.5)
Sexual functioning: Change at Week 13 Number Analyzed 129 participants 126 participants
4.1  (16.1) 1.6  (17.7)
Sexual functioning: Change at Week 16 Number Analyzed 128 participants 124 participants
4.8  (15.9) 1.1  (18.1)
Sexual functioning: Change at PS Visit Number Analyzed 120 participants 121 participants
9.6  (19.2) 4.1  (21.8)
Systematic therapy side effects: Baseline Number Analyzed 159 participants 162 participants
8.7  (10.8) 9.5  (11.5)
Systematic therapy side effects: Change at Week 5 Number Analyzed 156 participants 153 participants
4.3  (10.0) 3.9  (10.5)
Systematic therapy side effects: Change at Week 9 Number Analyzed 153 participants 154 participants
6.7  (10.8) 5.9  (12.1)
Systematic therapy side effects: Change at Week 13 Number Analyzed 154 participants 155 participants
7.3  (11.0) 6.2  (13.1)
Systematic therapy side effects: Change at Week 16 Number Analyzed 149 participants 149 participants
7.5  (12.9) 7.1  (12.6)
Systematic therapy side effects:Change at PS Visit Number Analyzed 141 participants 142 participants
7.0  (12.0) 5.9  (12.1)
Upset by hair loss: Baseline Number Analyzed 19 participants 18 participants
24.6  (26.9) 35.2  (31.3)
Upset by hair loss: Change at Week 5 Number Analyzed 12 participants 10 participants
11.1  (32.8) -3.3  (18.9)
Upset by hair loss: Change at Week 9 Number Analyzed 11 participants 11 participants
9.1  (44.9) -9.1  (26.2)
Upset by hair loss: Change at Week 13 Number Analyzed 10 participants 11 participants
16.7  (36.0) -3.0  (34.8)
Upset by hair loss: Change at Week 16 Number Analyzed 11 participants 14 participants
21.2  (34.2) -7.1  (23.3)
Upset by hair loss: Change at PS Visit Number Analyzed 13 participants 13 participants
30.8  (37.2) -2.6  (34.6)
18.Secondary Outcome
Title Percentage of Participants With Adverse Events
Hide Description An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time Frame Baseline up to 22 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
Arm/Group Title Experimental: Taselisib + Letrozole Placebo Comparator: Placebo + Letrozole
Hide Arm/Group Description:
Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
Overall Number of Participants Analyzed 167 167
Measure Type: Number
Unit of Measure: percentage of participants
91.0 83.2
Time Frame Baseline up to 22 weeks
Adverse Event Reporting Description The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
 
Arm/Group Title Experimental: Taselisib + Letrozole Placebo Comparator: Placebo + Letrozole
Hide Arm/Group Description Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks. Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks.
All-Cause Mortality
Experimental: Taselisib + Letrozole Placebo Comparator: Placebo + Letrozole
Affected / at Risk (%) Affected / at Risk (%)
Total   1/167 (0.60%)   0/167 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Experimental: Taselisib + Letrozole Placebo Comparator: Placebo + Letrozole
Affected / at Risk (%) Affected / at Risk (%)
Total   20/167 (11.98%)   4/167 (2.40%) 
Cardiac disorders     
Cardiac failure acute  1  0/167 (0.00%)  1/167 (0.60%) 
Gastrointestinal disorders     
Diarrhoea  1  5/167 (2.99%)  0/167 (0.00%) 
Colitis  1  2/167 (1.20%)  0/167 (0.00%) 
Enterocolitis  1  1/167 (0.60%)  0/167 (0.00%) 
Enterocolitis haemorrhagic  1  1/167 (0.60%)  0/167 (0.00%) 
Stomatitis  1  1/167 (0.60%)  0/167 (0.00%) 
General disorders     
Impaired healing  1  1/167 (0.60%)  0/167 (0.00%) 
Sudden death  1  1/167 (0.60%)  0/167 (0.00%) 
Infections and infestations     
Postoperative wound infection  1  2/167 (1.20%)  1/167 (0.60%) 
Erysipelas  1  2/167 (1.20%)  0/167 (0.00%) 
Bacterial diarrhoea  1  1/167 (0.60%)  0/167 (0.00%) 
Cytomegalovirus infection  1  1/167 (0.60%)  0/167 (0.00%) 
Diarrhoea infectious  1  1/167 (0.60%)  0/167 (0.00%) 
Gastroenteritis  1  1/167 (0.60%)  0/167 (0.00%) 
Haematoma infection  1  0/167 (0.00%)  1/167 (0.60%) 
Pneumonia  1  1/167 (0.60%)  0/167 (0.00%) 
Urinary tract infection  1  1/167 (0.60%)  0/167 (0.00%) 
Metabolism and nutrition disorders     
Dehydration  1  1/167 (0.60%)  0/167 (0.00%) 
Nervous system disorders     
Hypertensive encephalopathy  1  0/167 (0.00%)  1/167 (0.60%) 
Memory impairment  1  1/167 (0.60%)  0/167 (0.00%) 
Reproductive system and breast disorders     
Breast pain  1  0/167 (0.00%)  1/167 (0.60%) 
Respiratory, thoracic and mediastinal disorders     
Pneumonitis  1  1/167 (0.60%)  0/167 (0.00%) 
Skin and subcutaneous tissue disorders     
Erythema multiforme  1  1/167 (0.60%)  0/167 (0.00%) 
Rash  1  1/167 (0.60%)  0/167 (0.00%) 
1
Term from vocabulary, MedDRA V19.0,19.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Experimental: Taselisib + Letrozole Placebo Comparator: Placebo + Letrozole
Affected / at Risk (%) Affected / at Risk (%)
Total   130/167 (77.84%)   126/167 (75.45%) 
Gastrointestinal disorders     
Diarrhoea  1  49/167 (29.34%)  20/167 (11.98%) 
Nausea  1  35/167 (20.96%)  19/167 (11.38%) 
Stomatitis  1  22/167 (13.17%)  5/167 (2.99%) 
Dry mouth  1  6/167 (3.59%)  14/167 (8.38%) 
Constipation  1  10/167 (5.99%)  7/167 (4.19%) 
Vomiting  1  10/167 (5.99%)  6/167 (3.59%) 
Dyspepsia  1  9/167 (5.39%)  1/167 (0.60%) 
General disorders     
Fatigue  1  33/167 (19.76%)  40/167 (23.95%) 
Asthenia  1  17/167 (10.18%)  16/167 (9.58%) 
Infections and infestations     
Viral upper respiratory tract infection  1  6/167 (3.59%)  13/167 (7.78%) 
Urinary tract infection  1  7/167 (4.19%)  9/167 (5.39%) 
Investigations     
Alanine aminotransferase increased  1  9/167 (5.39%)  4/167 (2.40%) 
Metabolism and nutrition disorders     
Hyperglycaemia  1  26/167 (15.57%)  12/167 (7.19%) 
Decreased appetite  1  11/167 (6.59%)  6/167 (3.59%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  19/167 (11.38%)  36/167 (21.56%) 
Back pain  1  6/167 (3.59%)  10/167 (5.99%) 
Nervous system disorders     
Headache  1  16/167 (9.58%)  18/167 (10.78%) 
Dizziness  1  9/167 (5.39%)  9/167 (5.39%) 
Psychiatric disorders     
Insomnia  1  6/167 (3.59%)  11/167 (6.59%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  9/167 (5.39%)  8/167 (4.79%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  14/167 (8.38%)  8/167 (4.79%) 
Rash  1  15/167 (8.98%)  5/167 (2.99%) 
Pruritus  1  6/167 (3.59%)  9/167 (5.39%) 
Dry skin  1  10/167 (5.99%)  3/167 (1.80%) 
Vascular disorders     
Hot flush  1  25/167 (14.97%)  33/167 (19.76%) 
Hypertension  1  10/167 (5.99%)  11/167 (6.59%) 
1
Term from vocabulary, MedDRA V19.0,19.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 1-800-821-8590
Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT02273973     History of Changes
Other Study ID Numbers: GO28888
2013-000568-28 ( EudraCT Number )
First Submitted: October 22, 2014
First Posted: October 24, 2014
Results First Submitted: March 6, 2018
Results First Posted: May 21, 2018
Last Update Posted: May 21, 2018