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Trial record 18 of 168 for:    pertuzumab

Pertuzumab and Trastuzumab as Neoadjuvant Treatment in Patients With HER2-Positive Breast Cancer

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ClinicalTrials.gov Identifier: NCT01937117
Recruitment Status : Active, not recruiting
First Posted : September 9, 2013
Results First Posted : April 12, 2019
Last Update Posted : April 12, 2019
Sponsor:
Collaborators:
Translational Breast Cancer Research Consortium
Genentech, Inc.
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Procedure: Positron emission tomography (PET)
Drug: Trastuzumab
Drug: Pertuzumab
Enrollment 88
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Trastuzumab and Pertuzumab
Hide Arm/Group Description

Preoperative treatment with trastuzumab (8 mg/kg loading dose, then 6 mg/kg every 3 weeks, IV) and pertuzumab (840 mg as a loading dose, then 420 mg every 3 weeks, IV) every 3 weeks for 4 doses (total 12 weeks or 3 months of treatment) as assessed by Positron Emission Tomography (PET)

Positron emission tomography (PET): PET will be performed at baseline and on day 15

Trastuzumab: 8 mg/kg loading dose, then 6 mg/kg every 3 weeks, IV

Pertuzumab: 840 mg as a loading dose, then 420 mg every 3 weeks, IV

Period Title: Overall Study
Started 88
Completed 75
Not Completed 13
Reason Not Completed
Disease Progression             7
Physician Decision             4
Adverse Event             2
Arm/Group Title Trastuzumab and Pertuzumab
Hide Arm/Group Description

Preoperative treatment with trastuzumab (8 mg/kg loading dose, then 6 mg/kg every 3 weeks, IV) and pertuzumab (840 mg as a loading dose, then 420 mg every 3 weeks, IV) every 3 weeks for 4 doses (total 12 weeks or 3 months of treatment) as assessed by Positron Emission Tomography (PET)

Positron emission tomography (PET): PET will be performed at baseline and on day 15

Trastuzumab: 8 mg/kg loading dose, then 6 mg/kg every 3 weeks, IV

Pertuzumab: 840 mg as a loading dose, then 420 mg every 3 weeks, IV

Overall Number of Baseline Participants 88
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Standard Deviation)
Unit of measure:  Years
Number Analyzed 88 participants
58  (12.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 88 participants
Female
88
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 88 participants
Hispanic or Latino
5
   5.7%
Not Hispanic or Latino
79
  89.8%
Unknown or Not Reported
4
   4.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 88 participants
White
75
  85.2%
Black or African American
7
   8.0%
Other
6
   6.8%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 88 participants
88
 100.0%
Eastern Cooperative Oncology Group (ECOG) Performance Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 88 participants
0
76
  86.4%
1
12
  13.6%
[1]
Measure Description: The ECOG scale measures performance status, with scores ranging from 0-5; 0= fully active, performs without restriction, 1= can ambulate, but restricted in physically strenuous activity, 2= ambulatory and capable of self-care, but unable to work, active for >50% of waking hours, 3= limited self-care, confined to bed or chair for >50% of waking hours, 4= completely disabled, totally confined to bed/chair, 5= deceased
Baseline clinical tumor size   [1] 
Median (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 88 participants
3.7  (2)
[1]
Measure Description: Primary breast tumor size in centimeters (cm)
Clinical tumor T staging   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 88 participants
T1
0
   0.0%
T2
66
  75.0%
T3
19
  21.6%
T4
3
   3.4%
[1]
Measure Description: T refers to the extent (size) of the tumor and is based off the staging system used for breast cancer is the American Joint Committee on Cancer (AJCC). Staging is as follows: T1= tumor <= 2cm in greatest dimension, T2= tumor >2cm in greatest dimension, T3= tumor >5cm in greatest dimension, and T4= tumor of any size with direct extension to chest wall (T4a) or skin (T4b). A higher number reflects a more progressive stage.
Baseline clinical nodal status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 88 participants
Negative
45
  51.1%
Positive
43
  48.9%
[1]
Measure Description: Based from the American Joint Committee on Cancer (AJCC) TNM system, this measures whether participants spread to lymph nodes near the breast.
Clinical tumor N staging   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 88 participants
N0
45
  51.1%
N1
38
  43.2%
N2
3
   3.4%
N3
2
   2.3%
[1]
Measure Description: AJCC staging: N0= no regional lymph node (LN) metastasis ("mets"), N1= mets in movable ipsilateral axillary LN; N2= mets in ipsilateral axillary LNs fixed or matted, or in clinically apparent ipsilateral internal mammary LN without of clinically evident axillary LN mets; N3= mets in ipsilateral infraclavicular LN, or in clinically apparent ipsilateral internal mammary LNs and in the presence of clinically evident axillary LN mets; or mets in ipsilateral supraclavicular LN with or without axillary or internal mammary lymph node involvement. A higher number reflects a greater region of mets.
Baseline clinical stage   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 88 participants
Stage II
74
  84.1%
Stage III
14
  15.9%
[1]
Measure Description: Based on AJCC TNM staging (as described above): earliest stage breast cancers are stage 0 (carcinoma in situ). It then ranges from stage I (1) through IV (4), with a higher stage reflecting worse outcome. Stage I= T1N0M0, Stage II= T0N1M0, T1N1M0, T2N0M0, T2N1M0, T3N0M0, Stage III= T0N2M0, T1N2M0, T2N2M0, T3N1M0, T3N2M0, T4N0M0, T4N1M0, T4N2M0, anyTN3M0.
Tumor Grade   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 88 participants
Grade 2
22
  25.0%
Grade 3
66
  75.0%
[1]
Measure Description: Tumor grade measures how much the cancer cells look like normal cells. Grading is as follows: Grade 1 (well differentiated)= the cells are slower-growing, and look more like normal breast tissue; Grade 2 (moderately differentiated)= the cells are growing at a speed of and look like cells somewhere between grades 1 and 3, Grade 3 (poorly differentiated) = the cells look very different from normal cells and will probably grow and spread faster. A higher grade reflects a worse prognosis.
Additional neoadjuvant therapy   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 88 participants
Yes
25
  28.4%
No
59
  67.0%
N/A
4
   4.5%
[1]
Measure Description: Study treatment was pertuzumab and trastuzumab. If required by care team, participants could receive additional treatment, outside of the protocol, prior to surgery.
Surgery   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 88 participants
Mastectomy
51
  58.0%
Breast-conserving therapy
33
  37.5%
N/A
4
   4.5%
[1]
Measure Description: Type of surgical intervention received.
1.Primary Outcome
Title Percent Change in Standardized Uptake Value (SUV) as Measured by SULmax on [18F]Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET)
Hide Description SULmax is the maximum SUV corrected for lean body mass. Change in SULmax from baseline to Day 15 on FDG PET in correlation with pathological complete response (pCR) in patients treated with preoperative pertuzumab/trastuzumab. pCR was defined as no viable invasive cancer in breast and axilla by local pathology review. SULmax was measured via spherical volume over the target primary breast cancer tissue.
Time Frame Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
Data was evaluable in only 83/88 participants. 28/83 obtained pCR whereas 55/83 did not show pCR
Arm/Group Title Trastuzumab and Pertuzumab
Hide Arm/Group Description:

Preoperative treatment with trastuzumab (8 mg/kg loading dose, then 6 mg/kg every 3 weeks, IV) and pertuzumab (840 mg as a loading dose, then 420 mg every 3 weeks, IV) every 3 weeks for 4 doses (total 12 weeks or 3 months of treatment) as assessed by Positron Emission Tomography (PET)

Positron emission tomography (PET): PET will be performed at baseline and on day 15

Trastuzumab: 8 mg/kg loading dose, then 6 mg/kg every 3 weeks, IV

Pertuzumab: 840 mg as a loading dose, then 420 mg every 3 weeks, IV

Overall Number of Participants Analyzed 83
Mean (Standard Deviation)
Unit of Measure: percent reduction in SULmax
pCR Number Analyzed 28 participants
61.9  (22.3)
no pCR Number Analyzed 55 participants
34.3  (31.9)
2.Secondary Outcome
Title Change in ptDNA With Response
Hide Description To correlate PIK3CA mutation status and other genomic alterations (mutations/somatic rearrangements) qualitatively and quantitatively in plasma tumor DNA (ptDNA) with pCR
Time Frame 3 months
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Change in PI3K Pathway Activation With Response
Hide Description To correlate PI3K pathway activation (e.g. PTEN low and/or PIK3CA mutation, HER 1-4 expression and/or phosphorylation) in tumor samples and pCR
Time Frame 3 months
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Changes in Ki67 With Response
Hide Description To correlate baseline and change (day 15) in Ki67 with pCR
Time Frame 3 months
Outcome Measure Data Not Reported
Time Frame Up to 16 weeks (30 days after last dose of study drug)
Adverse Event Reporting Description Adverse events were collected at regular cycle visits (every 2-3 weeks) by investigator assessment and again at post-study follow-up.
 
Arm/Group Title Trastuzumab and Pertuzumab
Hide Arm/Group Description

Preoperative treatment with trastuzumab (8 mg/kg loading dose, then 6 mg/kg every 3 weeks, IV) and pertuzumab (840 mg as a loading dose, then 420 mg every 3 weeks, IV) every 3 weeks for 4 doses (total 12 weeks or 3 months of treatment) as assessed by Positron Emission Tomography (PET)

Positron emission tomography (PET): PET will be performed at baseline and on day 15

Trastuzumab: 8 mg/kg loading dose, then 6 mg/kg every 3 weeks, IV

Pertuzumab: 840 mg as a loading dose, then 420 mg every 3 weeks, IV

All-Cause Mortality
Trastuzumab and Pertuzumab
Affected / at Risk (%)
Total   0/88 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Trastuzumab and Pertuzumab
Affected / at Risk (%) # Events
Total   2/88 (2.27%)    
Gastrointestinal disorders   
Enterocolitis  1 [1]  1/88 (1.14%)  1
Injury, poisoning and procedural complications   
Sepsis  1 [1]  1/88 (1.14%)  2
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
[1]
Not related to study product.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4.4%
Trastuzumab and Pertuzumab
Affected / at Risk (%) # Events
Total   88/88 (100.00%)    
Gastrointestinal disorders   
Diarrhea  1  80/88 (90.91%)  80
Dyspepsia  1  5/88 (5.68%)  5
Mucositis  1  12/88 (13.64%)  12
Nausea  1  24/88 (27.27%)  24
General disorders   
Fatigue  1  30/88 (34.09%)  30
Chills  1  10/88 (11.36%)  10
Nervous system disorders   
Headache  1  13/88 (14.77%)  13
Dysgeusia  1  6/88 (6.82%)  6
Skin and subcutaneous tissue disorders   
Rash (NOS)  1  17/88 (19.32%)  17
Dry skin  1  5/88 (5.68%)  5
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title: Roisin Connolly
Organization: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Phone: (410) 614-9217
Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT01937117     History of Changes
Other Study ID Numbers: TBCRC 026
TBCRC026 ( Other Identifier: Translational Breast Cancer Research Consortium (TBCRC) )
NA_00080994 ( Other Identifier: JHMIRB )
First Submitted: September 3, 2013
First Posted: September 9, 2013
Results First Submitted: March 18, 2019
Results First Posted: April 12, 2019
Last Update Posted: April 12, 2019