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A Study of Taselisib + Fulvestrant Versus Placebo + Fulvestrant in Participants With Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy (SANDPIPER)

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: NCT02340221
Recruitment Status : Active, not recruiting
First Posted : January 16, 2015
Results First Posted : January 25, 2019
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Drug: Taselisib
Drug: Placebo
Drug: Fulvestrant
Enrollment 631
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo+Fulvestrant Taselisib+Fulvestrant
Hide Arm/Group Description Participants received placebo taken orally once daily (QD) beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by intramuscular (IM) injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28‑day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor. Participants received taselisib 4 milligrams (mg) taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.
Period Title: Overall Study
Started 214 417
Completed 0 0
Not Completed 214 417
Reason Not Completed
Death             58             101
Withdrawal by Participant             14             22
Lost to Follow-up             2             3
Reason Not Specified             0             1
Continued on study             140             290
Arm/Group Title Placebo+Fulvestrant Taselisib+Fulvestrant Total
Hide Arm/Group Description Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28‑day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor. Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor. Total of all reporting groups
Overall Number of Baseline Participants 214 417 631
Hide Baseline Analysis Population Description
The intent-to-treat (ITT) population included all randomized participants regardless of whether they received any amount of study treatment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 214 participants 417 participants 631 participants
60.7  (10.0) 60.1  (9.9) 60.3  (9.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 214 participants 417 participants 631 participants
Female
214
 100.0%
417
 100.0%
631
 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 214 participants 417 participants 631 participants
Not Hispanic or Latino
166
  77.6%
334
  80.1%
500
  79.2%
Hispanic or Latino
26
  12.1%
48
  11.5%
74
  11.7%
Unknown
22
  10.3%
35
   8.4%
57
   9.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 214 participants 417 participants 631 participants
White
147
  68.7%
285
  68.3%
432
  68.5%
Asian
38
  17.8%
72
  17.3%
110
  17.4%
Unknown
14
   6.5%
30
   7.2%
44
   7.0%
American Indian or Alaska Native
13
   6.1%
24
   5.8%
37
   5.9%
Black or African American
2
   0.9%
2
   0.5%
4
   0.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
3
   0.7%
3
   0.5%
Multiple
0
   0.0%
1
   0.2%
1
   0.2%
1.Primary Outcome
Title Progression-Free Survival (PFS) as Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1)
Hide Description PFS was defined as the time from randomization to disease progression as determined by the investigator with the use of RECIST v1.1 or death due to any cause, whichever occurred earlier. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression.
Time Frame From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants with PIK3CA-mutant tumors, regardless of whether they received any amount of study treatment.
Arm/Group Title Placebo+Fulvestrant Taselisib+Fulvestrant
Hide Arm/Group Description:
Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28‑day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.
Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.
Overall Number of Participants Analyzed 176 340
Median (95% Confidence Interval)
Unit of Measure: months
5.39
(3.68 to 7.29)
7.43
(7.26 to 9.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo+Fulvestrant, Taselisib+Fulvestrant
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0037
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.70
Confidence Interval (2-Sided) 95%
0.56 to 0.89
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With Objective Response (Partial Response [PR] Plus Complete Response [CR]), as Assessed Using RECIST v.1.1
Hide Description PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions).
Time Frame From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants with PIK3CA-mutant tumors and measurable disease at baseline, regardless of whether they received any amount of study treatment.
Arm/Group Title Placebo+Fulvestrant Taselisib+Fulvestrant
Hide Arm/Group Description:
Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28‑day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.
Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.
Overall Number of Participants Analyzed 134 264
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
11.9
(7.1 to 18.3)
28.0
(22.7 to 33.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo+Fulvestrant, Taselisib+Fulvestrant
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
3.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS was defined as the time from the date of randomization to the date of death due to any cause.
Time Frame From randomization up to death from any cause (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants with PIK3CA-mutant tumors, regardless of whether they received any amount of study treatment.
Arm/Group Title Placebo+Fulvestrant Taselisib+Fulvestrant
Hide Arm/Group Description:
Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28‑day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.
Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.
Overall Number of Participants Analyzed 176 340
Median (95% Confidence Interval)
Unit of Measure: months
23.56 [1] 
(18.00 to NA)
26.81 [1] 
(21.29 to NA)
[1]
Upper limit of confidence interval was not estimable due to the low number of participants with events.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo+Fulvestrant, Taselisib+Fulvestrant
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.85
Confidence Interval (2-Sided) 95%
0.58 to 1.25
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants With Clinical Benefit, as Assessed According to RECIST v1.1
Hide Description Clinical benefit was defined as objective response (PR+CR), or no disease progression lasting for more than or equal to (>/=) 24 weeks since randomization. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions). Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression.
Time Frame From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants with PIK3CA-mutant tumors and measurable disease at baseline, regardless of whether they received any amount of study treatment.
Arm/Group Title Placebo+Fulvestrant Taselisib+Fulvestrant
Hide Arm/Group Description:
Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28‑day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.
Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.
Overall Number of Participants Analyzed 134 264
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
37.3
(29.1 to 45.7)
51.5
(45.3 to 57.7)
5.Secondary Outcome
Title Duration of Objective Response, as Assessed by Investigator Using RECIST v1.1
Time Frame Time from the first occurrence of a documented objective response to the time of the first documented disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants with PIK3CA-mutant tumors and measurable disease at baseline, regardless of whether they received any amount of study treatment. Data are reported for participants with responses.
Arm/Group Title Placebo+Fulvestrant Taselisib+Fulvestrant
Hide Arm/Group Description:
Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28‑day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.
Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.
Overall Number of Participants Analyzed 16 74
Median (95% Confidence Interval)
Unit of Measure: months
7.23 [1] 
(6.51 to NA)
8.74
(5.72 to 11.24)
[1]
Upper limit of confidence interval was not estimable due to the low number of participants with events.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo+Fulvestrant, Taselisib+Fulvestrant
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.77
Confidence Interval (2-Sided) 95%
0.23 to 2.59
Estimation Comments [Not Specified]
6.Secondary Outcome
Title PFS as Assessed by Blinded Independent Central Review (BICR) Using RECIST v1.1
Hide Description PFS was defined as the time from randomization to disease progression as determined by BICR with the use of RECIST v1.1 or death due to any cause, whichever occurred earlier. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression.
Time Frame From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants with PIK3CA-mutant tumors, regardless of whether they received any amount of study treatment.
Arm/Group Title Placebo+Fulvestrant Taselisib+Fulvestrant
Hide Arm/Group Description:
Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28‑day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.
Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.
Overall Number of Participants Analyzed 176 340
Median (95% Confidence Interval)
Unit of Measure: months
5.39
(3.68 to 9.23)
8.97
(7.39 to 9.49)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo+Fulvestrant, Taselisib+Fulvestrant
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0023
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.66
Confidence Interval (2-Sided) 95%
0.51 to 0.86
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Participants With Adverse Events
Hide Description An adverse event was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.
Time Frame From randomization up to the 15 Oct 2017 data cutoff, approximately 2.5 years.
Hide Outcome Measure Data
Hide Analysis Population Description
The safety-evaluable population included all randomized participants who received at least one dose of taselisib or placebo or fulvestrant.
Arm/Group Title Placebo+Fulvestrant Taselisib+Fulvestrant
Hide Arm/Group Description:
Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28‑day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.
Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.
Overall Number of Participants Analyzed 213 416
Measure Type: Number
Unit of Measure: percentage of participants
89.7 95.4
8.Secondary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of Taselisib
Hide Description [Not Specified]
Time Frame 1 to 4 hours (hrs) post-dose on Cycle (C) 1, Day (D) 1; 0 to 3 hrs pre-dose and 2 to 6 hrs post dose on Cycle 2, Day 1 (each cycle=28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic (PK) population included all participants who received at least one dose of taselisib and provided valid (adequately documented dose time and PK sample time) PK assessments.
Arm/Group Title Taselisib+Fulvestrant
Hide Arm/Group Description:
Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.
Overall Number of Participants Analyzed 417
Mean (Standard Deviation)
Unit of Measure: ng/mL
C1D1 Number Analyzed 417 participants
18.2  (14.6)
C2D1 Number Analyzed 359 participants
66.6  (35.2)
9.Secondary Outcome
Title Minimum Observed Plasma Concentration (Cmin) of Taselisib
Hide Description [Not Specified]
Time Frame 1 to 4 hrs post-dose on Cycle 1, Day 1; 0 to 3 hrs pre-dose and 2 to 6 hrs post dose on Cycle 2, Day 1; 0 to 3 hrs pre-dose on Cycle 6, Day 1 (each cycle=28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The PK population included all participants who received at least one dose of taselisib and provided valid (adequately documented dose time and PK sample time) PK assessments.
Arm/Group Title Taselisib+Fulvestrant
Hide Arm/Group Description:
Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.
Overall Number of Participants Analyzed 417
Mean (Standard Deviation)
Unit of Measure: ng/mL
C2D1 Number Analyzed 377 participants
42.8  (26.6)
C6D1 Number Analyzed 213 participants
35.3  (31.5)
10.Secondary Outcome
Title Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score
Hide Description The EORTC QLQ-C30 consists of 30 questions that comprise aspects of participant's functioning assessment (physical, emotional, role, cognitive, and social); symptom scales (fatigue; nausea, vomiting, and pain; the global health/quality of life [QoL]); and single items (dyspnoea, insomnia, appetite loss, constipation, diarrhoea, and financial difficulties), within a recall period of “the past week.” Most questions used a 4-point scale (1=Not at all to 4=Very much; two questions used a 7-point scale (1=Very poor to 7=Excellent). Scores were averaged and transformed to a 0-100 scale; a higher score for Global Qol/functional scales=better level of functioning; a higher score for symptom scale=greater degree of symptoms.
Time Frame Baseline, C2D1 up to C7D1 (each cycle=28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants with PIK3CA-mutant tumors, regardless of whether they received any amount of study treatment. Data are reported for evaluable participants.
Arm/Group Title Placebo+Fulvestrant Taselisib+Fulvestrant
Hide Arm/Group Description:
Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28‑day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.
Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.
Overall Number of Participants Analyzed 176 340
Mean (Standard Deviation)
Unit of Measure: score on a scale
Appetite Loss: Baseline Number Analyzed 159 participants 312 participants
15.9  (25.9) 15.3  (23.3)
Appetite Loss: Change at C2D1 Number Analyzed 147 participants 292 participants
-0.2  (25.7) 6.2  (26.2)
Appetite Loss: Change at C3D1 Number Analyzed 117 participants 260 participants
-4.3  (27.2) 8.7  (28.1)
Appetite Loss: Change at C4D1 Number Analyzed 100 participants 231 participants
-1.7  (26.1) 8.4  (28.1)
Appetite Loss: Change at C5D1 Number Analyzed 75 participants 206 participants
-0.4  (26.6) 6.0  (27.2)
Appetite Loss: Change at C6D1 Number Analyzed 66 participants 171 participants
-0.5  (22.3) 6.6  (27.2)
Appetite Loss: Change at C7D1 Number Analyzed 58 participants 145 participants
-5.7  (28.7) 4.6  (26.5)
Cognitive Functioning: Baseline Number Analyzed 160 participants 312 participants
85.3  (18.1) 85.9  (18.7)
Cognitive Functioning: Change at C2D1 Number Analyzed 147 participants 292 participants
0.7  (16.5) -1.1  (16.8)
Cognitive Functioning: Change at C3D1 Number Analyzed 117 participants 260 participants
0.9  (17.9) -2.9  (19.1)
Cognitive Functioning: Change at C4D1 Number Analyzed 100 participants 231 participants
1.8  (18.9) -1.7  (18.4)
Cognitive Functioning: Change at C5D1 Number Analyzed 76 participants 207 participants
-1.5  (17.7) -3.2  (17.7)
Cognitive Functioning: Change at C6D1 Number Analyzed 66 participants 171 participants
-0.5  (18.5) -2.8  (17.6)
Cognitive Functioning: Change at C7D1 Number Analyzed 58 participants 145 participants
-2.3  (18.1) -0.8  (18.8)
Constipation: Baseline Number Analyzed 160 participants 312 participants
15.8  (23.9) 14.5  (23.7)
Constipation: Change at C2D1 Number Analyzed 147 participants 291 participants
0.0  (24.0) -6.0  (21.1)
Constipation: Change at C3D1 Number Analyzed 117 participants 260 participants
-2.3  (25.0) -4.9  (20.8)
Constipation: Change at C4D1 Number Analyzed 99 participants 231 participants
-2.7  (24.6) -5.5  (22.0)
Constipation: Change at C5D1 Number Analyzed 76 participants 207 participants
-1.3  (22.7) -4.0  (21.0)
Constipation: Change at C6D1 Number Analyzed 66 participants 170 participants
-3.0  (27.3) -3.5  (21.8)
Constipation: Change at C7D1 Number Analyzed 58 participants 145 participants
-4.6  (24.5) -6.9  (22.5)
Diarrhoea: Baseline Number Analyzed 159 participants 311 participants
6.3  (15.1) 5.0  (14.4)
Diarrhoea: Change at C2D1 Number Analyzed 147 participants 292 participants
-0.5  (17.9) 10.2  (22.4)
Diarrhoea: Change at C3D1 Number Analyzed 117 participants 260 participants
-0.9  (16.6) 13.7  (26.3)
Diarrhoea: Change at C4D1 Number Analyzed 100 participants 231 participants
-2.7  (21.0) 13.1  (28.9)
Diarrhoea: Change at C5D1 Number Analyzed 76 participants 207 participants
-2.6  (19.4) 11.1  (27.7)
Diarrhoea: Change at C6D1 Number Analyzed 66 participants 171 participants
-2.0  (17.4) 14.0  (29.1)
Diarrhoea: Change at C7D1 Number Analyzed 58 participants 145 participants
1.1  (20.7) 15.6  (30.9)
Dyspnoea: Baseline Number Analyzed 160 participants 311 participants
15.0  (23.0) 15.4  (22.2)
Dyspnoea: Change at C2D1 Number Analyzed 146 participants 291 participants
4.1  (23.5) -2.1  (19.5)
Dyspnoea: Change at C3D1 Number Analyzed 117 participants 260 participants
2.8  (20.3) 0.0  (20.9)
Dyspnoea: Change at C4D1 Number Analyzed 100 participants 231 participants
0.7  (23.2) 0.0  (23.3)
Dyspnoea: Change at C5D1 Number Analyzed 76 participants 207 participants
2.6  (26.5) 1.6  (23.2)
Dyspnoea: Change at C6D1 Number Analyzed 66 participants 170 participants
3.0  (26.6) 0.2  (23.4)
Dyspnoea: Change at C7D1 Number Analyzed 58 participants 145 participants
1.7  (24.5) -2.1  (21.2)
Emotional Functioning: Baseline Number Analyzed 160 participants 312 participants
73.1  (22.1) 71.9  (22.1)
Emotional Functioning: Change at C2D1 Number Analyzed 147 participants 292 participants
4.0  (17.9) 5.1  (18.5)
Emotional Functioning: Change at C3D1 Number Analyzed 117 participants 260 participants
4.5  (19.1) 2.3  (21.6)
Emotional Functioning: Change at C4D1 Number Analyzed 100 participants 231 participants
4.5  (18.5) 2.6  (19.7)
Emotional Functioning: Change at C5D1 Number Analyzed 76 participants 207 participants
5.2  (20.1) -0.4  (21.8)
Emotional Functioning: Change at C6D1 Number Analyzed 66 participants 171 participants
2.1  (20.5) 2.4  (21.6)
Emotional Functioning: Change at C7D1 Number Analyzed 58 participants 145 participants
5.3  (20.7) 2.8  (19.7)
Fatigue: Baseline Number Analyzed 160 participants 312 participants
30.8  (22.5) 30.8  (22.0)
Fatigue: Change at C2D1 Number Analyzed 147 participants 292 participants
2.0  (19.2) -0.5  (18.8)
Fatigue: Change at C3D1 Number Analyzed 117 participants 260 participants
-1.5  (19.5) 1.8  (21.5)
Fatigue: Change at C4D1 Number Analyzed 100 participants 231 participants
-0.2  (19.1) 2.4  (21.9)
Fatigue: Change at C5D1 Number Analyzed 76 participants 207 participants
-0.1  (20.8) 2.8  (20.4)
Fatigue: Change at C6D1 Number Analyzed 66 participants 171 participants
3.3  (20.0) 2.4  (20.5)
Fatigue: Change at C7D1 Number Analyzed 58 participants 145 participants
1.0  (20.0) 1.8  (20.5)
Financial Difficulties: Baseline Number Analyzed 160 participants 310 participants
18.5  (25.8) 19.2  (27.1)
Financial Difficulties: Change at C2D1 Number Analyzed 147 participants 287 participants
-1.1  (20.4) -2.8  (21.4)
Financial Difficulties: Change at C3D1 Number Analyzed 117 participants 258 participants
-0.9  (24.9) -1.6  (24.4)
Financial Difficulties: Change at C4D1 Number Analyzed 100 participants 230 participants
0.7  (25.1) -0.3  (23.7)
Financial Difficulties: Change at C5D1 Number Analyzed 76 participants 205 participants
-0.4  (28.0) 0.3  (24.9)
Financial Difficulties: Change at C6D1 Number Analyzed 66 participants 169 participants
5.6  (30.1) 0.4  (23.6)
Financial Difficulties: Change at C7D1 Number Analyzed 58 participants 143 participants
-0.6  (26.1) 2.1  (23.1)
Global Health Status/ QoL: Baseline Number Analyzed 160 participants 311 participants
65.2  (18.4) 67.4  (20.3)
Global Health Status/ QoL: Change at C2D1 Number Analyzed 147 participants 291 participants
-0.1  (16.7) 1.0  (19.9)
Global Health Status/ QoL: Change at C3D1 Number Analyzed 117 participants 259 participants
-1.0  (18.5) -1.5  (20.9)
Global Health Status/ QoL: Change at C4D1 Number Analyzed 100 participants 230 participants
-1.5  (18.6) -1.6  (20.3)
Global Health Status/ QoL: Change at C5D1 Number Analyzed 76 participants 207 participants
0.3  (19.9) -2.8  (20.3)
Global Health Status/ QoL: Change at C6D1 Number Analyzed 66 participants 171 participants
-1.6  (18.6) -3.4  (19.5)
Global Health Status/ QoL: Change at C7D1 Number Analyzed 58 participants 145 participants
-1.1  (18.9) -1.0  (18.9)
Insomnia: Baseline Number Analyzed 160 participants 311 participants
26.0  (27.6) 26.5  (27.7)
Insomnia: Change at C2D1 Number Analyzed 146 participants 289 participants
-0.9  (24.4) -3.8  (23.7)
Insomnia: Change at C3D1 Number Analyzed 117 participants 260 participants
-3.4  (30.1) -4.1  (26.4)
Insomnia: Change at C4D1 Number Analyzed 100 participants 231 participants
-4.0  (28.9) -1.0  (26.8)
Insomnia: Change at C5D1 Number Analyzed 76 participants 206 participants
-0.4  (29.1) -3.9  (25.6)
Insomnia: Change at C6D1 Number Analyzed 66 participants 170 participants
-2.0  (30.3) -2.4  (28.2)
Insomnia: Change at C7D1 Number Analyzed 57 participants 145 participants
-4.1  (28.2) -1.8  (27.2)
Nausea/Vomiting: Baseline Number Analyzed 160 participants 312 participants
5.9  (13.4) 6.7  (13.7)
Nausea/Vomiting: Change at C2D1 Number Analyzed 147 participants 292 participants
0.1  (11.9) 1.6  (18.1)
Nausea/Vomiting: Change at C3D1 Number Analyzed 117 participants 260 participants
0.7  (15.2) 2.2  (17.6)
Nausea/Vomiting: Change at C4D1 Number Analyzed 100 participants 231 participants
0.3  (17.9) 2.3  (18.6)
Nausea/Vomiting: Change at C5D1 Number Analyzed 76 participants 207 participants
-1.1  (18.3) 0.5  (15.4)
Nausea/Vomiting: Change at C6D1 Number Analyzed 66 participants 171 participants
1.5  (18.0) -0.6  (15.9)
Nausea/Vomiting: Change at C7D1 Number Analyzed 58 participants 145 participants
2.6  (15.5) 2.2  (18.8)
Pain: Baseline Number Analyzed 160 participants 312 participants
28.0  (25.4) 27.1  (24.9)
Pain: Change at C2D1 Number Analyzed 147 participants 292 participants
-0.2  (24.0) -5.0  (20.8)
Pain: Change at C3D1 Number Analyzed 117 participants 260 participants
-3.7  (23.3) -3.5  (22.6)
Pain: Change at C4D1 Number Analyzed 100 participants 231 participants
-3.2  (24.7) -1.7  (24.2)
Pain: Change at C5D1 Number Analyzed 76 participants 207 participants
-3.3  (24.2) -4.3  (22.9)
Pain: Change at C6D1 Number Analyzed 66 participants 171 participants
-1.0  (23.0) -2.2  (22.5)
Pain: Change at C7D1 Number Analyzed 58 participants 145 participants
0.3  (23.5) -4.4  (19.8)
Physical Functioning: Baseline Number Analyzed 160 participants 311 participants
76.7  (19.9) 78.4  (18.8)
Physical Functioning: Change at C2D1 Number Analyzed 147 participants 292 participants
-1.1  (13.4) 1.6  (12.7)
Physical Functioning: Change at C3D1 Number Analyzed 117 participants 260 participants
2.0  (14.1) 0.8  (15.7)
Physical Functioning: Change at C4D1 Number Analyzed 100 participants 231 participants
1.5  (16.1) 0.3  (15.7)
Physical Functioning: Change at C5D1 Number Analyzed 76 participants 207 participants
2.0  (17.7) 1.0  (13.5)
Physical Functioning: Change at C6D1 Number Analyzed 66 participants 171 participants
0.9  (18.4) 1.1  (14.9)
Physical Functioning: Change at C7D1 Number Analyzed 58 participants 145 participants
1.6  (16.2) 0.6  (14.2)
Role Functioning: Baseline Number Analyzed 160 participants 312 participants
79.1  (24.6) 78.7  (24.0)
Role Functioning: Change at C2D1 Number Analyzed 147 participants 292 participants
-2.0  (19.3) 1.7  (21.5)
Role Functioning: Change at C3D1 Number Analyzed 117 participants 260 participants
-0.4  (23.4) -1.0  (23.9)
Role Functioning: Change at C4D1 Number Analyzed 100 participants 231 participants
0.3  (23.0) 0.4  (24.2)
Role Functioning: Change at C5D1 Number Analyzed 76 participants 207 participants
1.8  (22.5) -1.6  (21.6)
Role Functioning: Change at C6D1 Number Analyzed 66 participants 171 participants
-1.3  (23.8) -1.6  (23.4)
Role Functioning: Change at C7D1 Number Analyzed 58 participants 145 participants
-0.3  (22.6) 0.0  (22.9)
Social Functioning: Baseline Number Analyzed 160 participants 312 participants
83.2  (21.8) 81.2  (23.1)
Social Functioning: Change at C2D1 Number Analyzed 147 participants 292 participants
-0.8  (19.9) 2.7  (20.0)
Social Functioning: Change at C3D1 Number Analyzed 117 participants 259 participants
1.3  (21.9) -0.8  (23.2)
Social Functioning: Change at C4D1 Number Analyzed 100 participants 231 participants
1.8  (18.2) -0.5  (21.3)
Social Functioning: Change at C5D1 Number Analyzed 76 participants 207 participants
0.9  (19.4) -1.0  (23.3)
Social Functioning: Change at C6D1 Number Analyzed 66 participants 170 participants
-0.8  (20.1) -1.6  (23.4)
Social Functioning: Change at C7D1 Number Analyzed 58 participants 145 participants
0.6  (21.2) 0.1  (19.7)
11.Secondary Outcome
Title Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score
Hide Description EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of functional scales (body image, sexual enjoyment, sexual functioning, future perspective [FP]) and symptom scales (systemic side effects [SE], upset by hair loss, arm symptoms, breast symptoms). Questions used a 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Scores were averaged and transformed to a 0-100 scale. Higher scores for the functional scales indicated a higher/better level of functioning/healthy functioning. Higher scores for the symptom scales indicated worse symptoms.
Time Frame Baseline, C2D1 up to C7D1 (each cycle=28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants with PIK3CA-mutant tumors, regardless of whether they received any amount of study treatment. Data are reported for evaluable participants.
Arm/Group Title Placebo+Fulvestrant Taselisib+Fulvestrant
Hide Arm/Group Description:
Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28‑day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.
Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.
Overall Number of Participants Analyzed 176 340
Mean (Standard Deviation)
Unit of Measure: score on a scale
Arm Symptoms: Baseline Number Analyzed 152 participants 304 participants
15.5  (18.8) 19.3  (21.1)
Arm Symptoms: Change at C2D1 Number Analyzed 140 participants 282 participants
0.1  (17.4) -5.4  (15.6)
Arm Symptoms: Change at C3D1 Number Analyzed 111 participants 250 participants
-0.7  (19.5) -6.1  (17.4)
Arm Symptoms: Change at C4D1 Number Analyzed 95 participants 219 participants
-1.4  (21.9) -5.8  (15.8)
Arm Symptoms: Change at C5D1 Number Analyzed 72 participants 203 participants
0.8  (17.0) -6.6  (15.7)
Arm Symptoms: Change at C6D1 Number Analyzed 63 participants 167 participants
1.1  (20.8) -5.0  (18.5)
Arm Symptoms: Change at C7D1 Number Analyzed 57 participants 140 participants
-1.2  (19.7) -6.0  (15.2)
Body Image: Baseline Number Analyzed 149 participants 300 participants
82.0  (21.7) 80.8  (22.5)
Body Image: Change at C2D1 Number Analyzed 135 participants 276 participants
1.8  (14.9) 1.5  (16.5)
Body Image: Change at C3D1 Number Analyzed 106 participants 242 participants
1.6  (18.0) 1.1  (20.6)
Body Image: Change at C4D1 Number Analyzed 92 participants 214 participants
1.1  (17.8) 1.8  (20.6)
Body Image: Change at C5D1 Number Analyzed 68 participants 198 participants
0.2  (19.5) 0.0  (17.5)
Body Image: Change at C6D1 Number Analyzed 60 participants 164 participants
1.1  (21.0) 0.4  (18.2)
Body Image: Change at C7D1 Number Analyzed 54 participants 137 participants
5.6  (18.8) -0.3  (18.2)
Breast Symptoms: Baseline Number Analyzed 151 participants 304 participants
8.7  (14.6) 11.0  (14.1)
Breast Symptoms: Change at C2D1 Number Analyzed 139 participants 282 participants
0.0  (13.7) -3.0  (11.8)
Breast Symptoms: Change at C3D1 Number Analyzed 112 participants 250 participants
-0.8  (13.3) -3.5  (11.6)
Breast Symptoms: Change at C4D1 Number Analyzed 95 participants 220 participants
0.1  (14.2) -3.0  (11.8)
Breast Symptoms: Change at C5D1 Number Analyzed 72 participants 203 participants
-0.9  (14.5) -2.0  (11.7)
Breast Symptoms: Change at C6D1 Number Analyzed 63 participants 167 participants
1.7  (16.0) -2.0  (12.9)
Breast Symptoms: Change at C7D1 Number Analyzed 57 participants 140 participants
0.3  (12.6) -3.2  (13.1)
Future Perspective: Baseline Number Analyzed 152 participants 303 participants
47.4  (31.5) 47.3  (29.6)
Future Perspective: Change at C2D1 Number Analyzed 139 participants 281 participants
3.4  (30.1) 6.8  (27.4)
Future Perspective: Change at C3D1 Number Analyzed 111 participants 247 participants
5.1  (29.5) 4.3  (30.5)
Future Perspective: Change at C4D1 Number Analyzed 95 participants 220 participants
6.0  (30.7) 7.0  (29.2)
Future Perspective: Change at C5D1 Number Analyzed 72 participants 202 participants
6.0  (30.3) 5.0  (26.8)
Future Perspective: Change at C6D1 Number Analyzed 63 participants 167 participants
6.9  (28.8) 9.0  (31.4)
Future Perspective: Change at C7D1 Number Analyzed 57 participants 139 participants
12.9  (29.4) 7.0  (30.2)
Sexual Enjoyment: Baseline Number Analyzed 27 participants 61 participants
51.9  (26.7) 62.8  (26.6)
Sexual Enjoyment: Change at C2D1 Number Analyzed 17 participants 35 participants
5.9  (21.2) 0.0  (18.1)
Sexual Enjoyment: Change at C3D1 Number Analyzed 14 participants 26 participants
4.8  (22.1) 1.3  (24.0)
Sexual Enjoyment: Change at C4D1 Number Analyzed 8 participants 24 participants
-8.3  (15.4) 4.2  (24.7)
Sexual Enjoyment: Change at C5D1 Number Analyzed 7 participants 26 participants
-4.8  (23.0) 2.6  (29.7)
Sexual Enjoyment: Change at C6D1 Number Analyzed 5 participants 17 participants
-6.7  (14.9) -5.9  (24.3)
Sexual Enjoyment: Change at C7D1 Number Analyzed 5 participants 14 participants
-13.3  (29.8) 9.5  (20.4)
Sexual Functioning: Baseline Number Analyzed 142 participants 291 participants
89.6  (17.9) 89.9  (17.3)
Sexual Functioning: Change at C2D1 Number Analyzed 126 participants 267 participants
1.6  (11.0) 1.5  (14.2)
Sexual Functioning: Change at C3D1 Number Analyzed 98 participants 235 participants
1.4  (10.6) 1.8  (15.6)
Sexual Functioning: Change at C4D1 Number Analyzed 86 participants 203 participants
1.9  (15.4) 1.6  (13.9)
Sexual Functioning: Change at C5D1 Number Analyzed 63 participants 186 participants
-0.8  (20.6) 2.6  (15.1)
Sexual Functioning: Change at C6D1 Number Analyzed 55 participants 156 participants
2.4  (18.8) 2.7  (15.0)
Sexual Functioning: Change at C7D1 Number Analyzed 49 participants 132 participants
2.7  (18.1) 2.3  (15.7)
Systematic Therapy SEs: Baseline Number Analyzed 152 participants 304 participants
15.7  (14.2) 14.7  (12.0)
Systematic Therapy SEs: Change at C2D1 Number Analyzed 140 participants 282 participants
0.2  (11.4) 2.5  (11.0)
Systematic Therapy SEs: Change at C3D1 Number Analyzed 112 participants 250 participants
1.2  (14.4) 4.0  (13.6)
Systematic Therapy SEs: Change at C4D1 Number Analyzed 95 participants 220 participants
1.5  (13.2) 4.0  (13.3)
Systematic Therapy SEs: Change at C5D1 Number Analyzed 72 participants 203 participants
2.4  (13.8) 5.5  (14.1)
Systematic Therapy SEs: Change at C6D1 Number Analyzed 63 participants 167 participants
2.9  (15.2) 5.7  (15.6)
Systematic Therapy SEs: Change at C7D1 Number Analyzed 57 participants 140 participants
3.5  (16.7) 4.8  (15.0)
Upset by Hair Loss: Baseline Number Analyzed 33 participants 63 participants
23.2  (28.2) 27.0  (29.2)
Upset by Hair Loss: Change at C2D1 Number Analyzed 14 participants 31 participants
-11.9  (28.1) -4.3  (22.3)
Upset by Hair Loss: Change at C3D1 Number Analyzed 13 participants 29 participants
-7.7  (30.9) 0.0  (26.7)
Upset by Hair Loss: Change at C4D1 Number Analyzed 13 participants 27 participants
2.6  (16.5) 0.0  (29.2)
Upset by Hair Loss: Change at C5D1 Number Analyzed 8 participants 28 participants
0.0  (25.2) 10.7  (27.3)
Upset by Hair Loss: Change at C6D1 Number Analyzed 6 participants 26 participants
11.1  (27.2) 16.7  (30.2)
Upset by Hair Loss: Change at C7D1 Number Analyzed 8 participants 26 participants
4.2  (11.8) 14.1  (32.9)
Time Frame From randomization up to the 15 Oct 2017 data cutoff, approximately 2.5 years
Adverse Event Reporting Description The safety-evaluable population included all randomized participants who received at least one dose of taselisib or placebo or fulvestrant regardless of the PIK3CA-mutation status of their tumors and separately for the subgroups of participants with and without detectable PIK3CA-mutant tumors, with participants allocated to the treatment arm associated with the regimen actually received.
 
Arm/Group Title Placebo+Fulvestrant Taselisib+Fulvestrant
Hide Arm/Group Description Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28‑day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor. Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.
All-Cause Mortality
Placebo+Fulvestrant Taselisib+Fulvestrant
Affected / at Risk (%) Affected / at Risk (%)
Total   57/213 (26.76%)   101/416 (24.28%) 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo+Fulvestrant Taselisib+Fulvestrant
Affected / at Risk (%) Affected / at Risk (%)
Total   19/213 (8.92%)   133/416 (31.97%) 
Blood and lymphatic system disorders     
Pancytopenia  1  0/213 (0.00%)  1/416 (0.24%) 
Anaemia  1  1/213 (0.47%)  0/416 (0.00%) 
Cardiac disorders     
Atrial fibrillation  1  0/213 (0.00%)  2/416 (0.48%) 
Cardiac failure congestive  1  0/213 (0.00%)  1/416 (0.24%) 
Myocardial infarction  1  0/213 (0.00%)  1/416 (0.24%) 
Supraventricular tachycardia  1  0/213 (0.00%)  1/416 (0.24%) 
Gastrointestinal disorders     
Diarrhoea  1  0/213 (0.00%)  32/416 (7.69%) 
Colitis  1  0/213 (0.00%)  14/416 (3.37%) 
Vomiting  1  1/213 (0.47%)  4/416 (0.96%) 
Nausea  1  1/213 (0.47%)  3/416 (0.72%) 
Enterocolitis  1  0/213 (0.00%)  2/416 (0.48%) 
Pancreatitis acute  1  0/213 (0.00%)  2/416 (0.48%) 
Small intestinal obstruction  1  0/213 (0.00%)  2/416 (0.48%) 
Alcoholic pancreatitis  1  0/213 (0.00%)  1/416 (0.24%) 
Dyspepsia  1  0/213 (0.00%)  1/416 (0.24%) 
Dysphagia  1  0/213 (0.00%)  1/416 (0.24%) 
Enteritis  1  0/213 (0.00%)  1/416 (0.24%) 
Gastric ulcer  1  0/213 (0.00%)  1/416 (0.24%) 
Gastritis  1  0/213 (0.00%)  1/416 (0.24%) 
Gastroduodenitis  1  0/213 (0.00%)  1/416 (0.24%) 
Oesophageal ulcer  1  0/213 (0.00%)  1/416 (0.24%) 
Oesophagitis  1  0/213 (0.00%)  1/416 (0.24%) 
Pancreatitis  1  0/213 (0.00%)  1/416 (0.24%) 
Stomatitis  1  0/213 (0.00%)  1/416 (0.24%) 
General disorders     
Pyrexia  1  0/213 (0.00%)  3/416 (0.72%) 
Death  1  0/213 (0.00%)  2/416 (0.48%) 
Asthenia  1  0/213 (0.00%)  1/416 (0.24%) 
Chest discomfort  1  0/213 (0.00%)  1/416 (0.24%) 
Chest pain  1  0/213 (0.00%)  1/416 (0.24%) 
Fatigue  1  0/213 (0.00%)  1/416 (0.24%) 
Mucosal inflammation  1  0/213 (0.00%)  1/416 (0.24%) 
Pain  1  1/213 (0.47%)  0/416 (0.00%) 
Hepatobiliary disorders     
Cholelithiasis  1  0/213 (0.00%)  1/416 (0.24%) 
Hepatotoxicity  1  0/213 (0.00%)  1/416 (0.24%) 
Infections and infestations     
Pneumonia  1  1/213 (0.47%)  9/416 (2.16%) 
Sepsis  1  1/213 (0.47%)  5/416 (1.20%) 
Diarrhoea infectious  1  0/213 (0.00%)  3/416 (0.72%) 
Cellulitis  1  0/213 (0.00%)  2/416 (0.48%) 
Enterocolitis infectious  1  0/213 (0.00%)  2/416 (0.48%) 
Appendicitis perforated  1  0/213 (0.00%)  1/416 (0.24%) 
Atypical mycobacterial pneumonia  1  0/213 (0.00%)  1/416 (0.24%) 
Bronchitis  1  0/213 (0.00%)  1/416 (0.24%) 
Clostridium difficile colitis  1  0/213 (0.00%)  1/416 (0.24%) 
Cystitis escherichia  1  0/213 (0.00%)  1/416 (0.24%) 
Gastroenteritis  1  0/213 (0.00%)  1/416 (0.24%) 
Gastroenteritis viral  1  0/213 (0.00%)  1/416 (0.24%) 
Respiratory tract infection  1  0/213 (0.00%)  1/416 (0.24%) 
Skin infection  1  0/213 (0.00%)  1/416 (0.24%) 
Urinary tract infection  1  0/213 (0.00%)  1/416 (0.24%) 
Urosepsis  1  0/213 (0.00%)  1/416 (0.24%) 
Injury, poisoning and procedural complications     
Clavicle fracture  1  0/213 (0.00%)  1/416 (0.24%) 
Fall  1  0/213 (0.00%)  1/416 (0.24%) 
Femur fracture  1  0/213 (0.00%)  1/416 (0.24%) 
Joint dislocation  1  0/213 (0.00%)  1/416 (0.24%) 
Toxicity to various agents  1  0/213 (0.00%)  1/416 (0.24%) 
Wrist fracture  1  1/213 (0.47%)  0/416 (0.00%) 
Investigations     
Alanine aminotransferase increased  1  1/213 (0.47%)  2/416 (0.48%) 
Aspartate aminotransferase increased  1  1/213 (0.47%)  1/416 (0.24%) 
Metabolism and nutrition disorders     
Dehydration  1  1/213 (0.47%)  6/416 (1.44%) 
Hyperglycaemia  1  0/213 (0.00%)  6/416 (1.44%) 
Decreased appetite  1  0/213 (0.00%)  1/416 (0.24%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  0/213 (0.00%)  1/416 (0.24%) 
Back pain  1  0/213 (0.00%)  1/416 (0.24%) 
Coccydynia  1  0/213 (0.00%)  1/416 (0.24%) 
Rhabdomyolysis  1  0/213 (0.00%)  1/416 (0.24%) 
Muscle spasms  1  1/213 (0.47%)  0/416 (0.00%) 
Muscular weakness  1  1/213 (0.47%)  0/416 (0.00%) 
Osteonecrosis of jaw  1  1/213 (0.47%)  0/416 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Intracranial tumour haemorrhage  1  0/213 (0.00%)  1/416 (0.24%) 
Nervous system disorders     
Headache  1  0/213 (0.00%)  3/416 (0.72%) 
Cerebral haematoma  1  0/213 (0.00%)  1/416 (0.24%) 
Cerebrovascular accident  1  2/213 (0.94%)  1/416 (0.24%) 
Hypoaesthesia  1  0/213 (0.00%)  1/416 (0.24%) 
Transient ischaemic attack  1  0/213 (0.00%)  1/416 (0.24%) 
Trigeminal neuralgia  1  0/213 (0.00%)  1/416 (0.24%) 
Facial paralysis  1  1/213 (0.47%)  0/416 (0.00%) 
VIth nerve paralysis  1  1/213 (0.47%)  0/416 (0.00%) 
Psychiatric disorders     
Mental status changes  1  0/213 (0.00%)  2/416 (0.48%) 
Confusional state  1  0/213 (0.00%)  1/416 (0.24%) 
Renal and urinary disorders     
Acute kidney injury  1  0/213 (0.00%)  2/416 (0.48%) 
Haematuria  1  0/213 (0.00%)  1/416 (0.24%) 
Renal failure  1  0/213 (0.00%)  1/416 (0.24%) 
Respiratory, thoracic and mediastinal disorders     
Pneumonitis  1  1/213 (0.47%)  9/416 (2.16%) 
Acute respiratory failure  1  0/213 (0.00%)  1/416 (0.24%) 
Cough  1  0/213 (0.00%)  1/416 (0.24%) 
Dyspnoea  1  1/213 (0.47%)  1/416 (0.24%) 
Interstitial lung disease  1  0/213 (0.00%)  1/416 (0.24%) 
Pleural effusion  1  2/213 (0.94%)  1/416 (0.24%) 
Pulmonary embolism  1  0/213 (0.00%)  1/416 (0.24%) 
Respiratory failure  1  0/213 (0.00%)  1/416 (0.24%) 
Pleuritic pain  1  1/213 (0.47%)  0/416 (0.00%) 
Pulmonary oedema  1  1/213 (0.47%)  0/416 (0.00%) 
Skin and subcutaneous tissue disorders     
Pruritus  1  0/213 (0.00%)  1/416 (0.24%) 
Rash  1  0/213 (0.00%)  1/416 (0.24%) 
Rash generalised  1  0/213 (0.00%)  1/416 (0.24%) 
Rash maculo-papular  1  0/213 (0.00%)  1/416 (0.24%) 
Toxic skin eruption  1  0/213 (0.00%)  1/416 (0.24%) 
Swelling face  1  1/213 (0.47%)  0/416 (0.00%) 
Vascular disorders     
Embolism  1  0/213 (0.00%)  1/416 (0.24%) 
Embolism venous  1  0/213 (0.00%)  1/416 (0.24%) 
Hypertension  1  0/213 (0.00%)  1/416 (0.24%) 
Shock  1  0/213 (0.00%)  1/416 (0.24%) 
1
Term from vocabulary, MedDRA version 20.1
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%
Placebo+Fulvestrant Taselisib+Fulvestrant
Affected / at Risk (%) Affected / at Risk (%)
Total   190/213 (89.20%)   396/416 (95.19%) 
Blood and lymphatic system disorders     
Anaemia  1  18/213 (8.45%)  34/416 (8.17%) 
Neutropenia  1  8/213 (3.76%)  27/416 (6.49%) 
Gastrointestinal disorders     
Diarrhoea  1  42/213 (19.72%)  235/416 (56.49%) 
Nausea  1  52/213 (24.41%)  140/416 (33.65%) 
Vomiting  1  23/213 (10.80%)  76/416 (18.27%) 
Stomatitis  1  7/213 (3.29%)  82/416 (19.71%) 
Abdominal pain  1  19/213 (8.92%)  51/416 (12.26%) 
Dry mouth  1  16/213 (7.51%)  51/416 (12.26%) 
Constipation  1  31/213 (14.55%)  28/416 (6.73%) 
Dyspepsia  1  4/213 (1.88%)  31/416 (7.45%) 
Abdominal pain upper  1  6/213 (2.82%)  23/416 (5.53%) 
Gastrooesophageal reflux disease  1  3/213 (1.41%)  21/416 (5.05%) 
General disorders     
Fatigue  1  38/213 (17.84%)  100/416 (24.04%) 
Asthenia  1  39/213 (18.31%)  76/416 (18.27%) 
Mucosal inflammation  1  11/213 (5.16%)  43/416 (10.34%) 
Pyrexia  1  7/213 (3.29%)  41/416 (9.86%) 
Infections and infestations     
Urinary tract infection  1  8/213 (3.76%)  34/416 (8.17%) 
Upper respiratory tract infection  1  10/213 (4.69%)  23/416 (5.53%) 
Investigations     
Aspartate aminotransferase increased  1  13/213 (6.10%)  30/416 (7.21%) 
Alanine aminotransferase increased  1  9/213 (4.23%)  31/416 (7.45%) 
Weight decreased  1  4/213 (1.88%)  34/416 (8.17%) 
Blood alkaline phosphatase increased  1  12/213 (5.63%)  10/416 (2.40%) 
Metabolism and nutrition disorders     
Hyperglycaemia  1  18/213 (8.45%)  157/416 (37.74%) 
Decreased appetite  1  22/213 (10.33%)  109/416 (26.20%) 
Hypokalaemia  1  2/213 (0.94%)  24/416 (5.77%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  24/213 (11.27%)  53/416 (12.74%) 
Arthralgia  1  27/213 (12.68%)  47/416 (11.30%) 
Musculoskeletal pain  1  14/213 (6.57%)  34/416 (8.17%) 
Myalgia  1  13/213 (6.10%)  33/416 (7.93%) 
Pain in extremity  1  18/213 (8.45%)  25/416 (6.01%) 
Bone pain  1  17/213 (7.98%)  19/416 (4.57%) 
Muscle spasms  1  6/213 (2.82%)  30/416 (7.21%) 
Nervous system disorders     
Headache  1  25/213 (11.74%)  83/416 (19.95%) 
Dizziness  1  18/213 (8.45%)  41/416 (9.86%) 
Dysgeusia  1  6/213 (2.82%)  40/416 (9.62%) 
Psychiatric disorders     
Insomnia  1  16/213 (7.51%)  33/416 (7.93%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  28/213 (13.15%)  53/416 (12.74%) 
Dyspnoea  1  16/213 (7.51%)  42/416 (10.10%) 
Skin and subcutaneous tissue disorders     
Rash  1  16/213 (7.51%)  74/416 (17.79%) 
Pruritus  1  16/213 (7.51%)  45/416 (10.82%) 
Alopecia  1  6/213 (2.82%)  47/416 (11.30%) 
Dry skin  1  10/213 (4.69%)  32/416 (7.69%) 
Vascular disorders     
Hot flush  1  26/213 (12.21%)  22/416 (5.29%) 
Hypertension  1  11/213 (5.16%)  28/416 (6.73%) 
1
Term from vocabulary, MedDRA version 20.1
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: (+41) 616878333
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02340221     History of Changes
Other Study ID Numbers: GO29058
2014-003185-25 ( EudraCT Number )
First Submitted: January 13, 2015
First Posted: January 16, 2015
Results First Submitted: December 18, 2018
Results First Posted: January 25, 2019
Last Update Posted: June 11, 2019