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Paclitaxel, Trastuzumab, and Pertuzumab in the Treatment of Metastatic HER2-Positive Breast Cancer

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ClinicalTrials.gov Identifier: NCT01276041
Recruitment Status : Completed
First Posted : January 13, 2011
Results First Posted : August 3, 2020
Last Update Posted : August 3, 2020
Sponsor:
Collaborators:
Genentech, Inc.
University of Pennsylvania
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Intervention Drug: pertuzumab in combination with trastuzumab and paclitaxel
Enrollment 70
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pertuzumab in Combination With Trastuzumab and Paclitaxel
Hide Arm/Group Description This is a phase II study of pertuzumab in combination with trastuzumab and paclitaxel for the treatment of patients with Stage IV HER2 (+) breast cancer.
Period Title: Overall Study
Started 70
Completed 67
Not Completed 3
Reason Not Completed
Adverse Event             2
Protocol Violation             1
Arm/Group Title Pertuzumab in Combination With Trastuzumab and Paclitaxel
Hide Arm/Group Description This is a phase II study of pertuzumab in combination with trastuzumab and paclitaxel for the treatment of patients with Stage IV HER2 (+) breast cancer.
Overall Number of Baseline Participants 70
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 70 participants
52
(26 to 84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants
Female
70
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants
Hispanic or Latino
8
  11.4%
Not Hispanic or Latino
62
  88.6%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants
American Indian or Alaska Native
0
   0.0%
Asian
9
  12.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
15
  21.4%
White
43
  61.4%
More than one race
0
   0.0%
Unknown or Not Reported
3
   4.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 70 participants
70
 100.0%
1.Primary Outcome
Title Percentage of Patients Who Are Progression Free at 6 Months or Later.
Hide Description Patients who are considered progression-free at 6 months are deemed successes. Failures are those patients who progressed before the 6 month mark. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pertuzumab in Combination With Trastuzumab and Paclitaxel
Hide Arm/Group Description:
This is a phase II study of pertuzumab in combination with trastuzumab and paclitaxel for the treatment of patients with Stage IV HER2 (+) breast cancer.
Overall Number of Participants Analyzed 70
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of partcipants
86
(75 to 93)
2.Secondary Outcome
Title Number of Participants by Response Rate Using the RECIST Criteria (Version 1.1)
Hide Description Extent of disease evaluation will consist of a CT of chest and abdomen +/- pelvis. Bone scan and PET are optional. Every 4th cycle, this can be done within +/- 2 weeks. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.",
Time Frame every 4th cycle CT of chest and abdomen +/- pelvis up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pertuzumab in Combination With Trastuzumab and Paclitaxel
Hide Arm/Group Description:
This is a phase II study of pertuzumab in combination with trastuzumab and paclitaxel for the treatment of patients with Stage IV HER2 (+) breast cancer.
Overall Number of Participants Analyzed 70
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response
15
  21.4%
Partial Response
27
  38.6%
Stable Disease
17
  24.3%
Progression of Disease
1
   1.4%
Not Evaulable
10
  14.3%
3.Secondary Outcome
Title Number of Participants Evaluated for Cardiac Safety
Hide Description We will also assess the LVEF at baseline and after every 4th cycle of treatment with an ECHO with a strain imaging analysis. When an ECHO cannot be done, a MUGA scan may be done.Patients who have surpassed the 6 month period may complete ECHO with strain imaging analysis or MUGA every 6 months +/- 1 month starting from the most recent ECHO scan date. This study will use the NCI Common Toxicity Criteria (CTC) AE version 4.0 for toxicity.
Time Frame baseline and every 4th cycle of treatment up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pertuzumab in Combination With Trastuzumab and Paclitaxel
Hide Arm/Group Description:
This is a phase II study of pertuzumab in combination with trastuzumab and paclitaxel for the treatment of patients with Stage IV HER2 (+) breast cancer.
Overall Number of Participants Analyzed 70
Measure Type: Count of Participants
Unit of Measure: Participants
70
 100.0%
4.Secondary Outcome
Title Number of Participants Evaluated With Toxicity
Hide Description This study will use the NCI Common Toxicity Criteria (CTC) AE version 4.0 for toxicity.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pertuzumab in Combination With Trastuzumab and Paclitaxel
Hide Arm/Group Description:
This is a phase II study of pertuzumab in combination with trastuzumab and paclitaxel for the treatment of patients with Stage IV HER2 (+) breast cancer.
Overall Number of Participants Analyzed 70
Measure Type: Count of Participants
Unit of Measure: Participants
70
 100.0%
Time Frame 2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pertuzumab in Combination With Trastuzumab and Paclitaxel
Hide Arm/Group Description This is a phase II study of pertuzumab in combination with trastuzumab and paclitaxel for the treatment of patients with Stage IV HER2 (+) breast cancer.
All-Cause Mortality
Pertuzumab in Combination With Trastuzumab and Paclitaxel
Affected / at Risk (%)
Total   36/70 (51.43%) 
Hide Serious Adverse Events
Pertuzumab in Combination With Trastuzumab and Paclitaxel
Affected / at Risk (%)
Total   18/70 (25.71%) 
Cardiac disorders   
Cardiac arrest   1/70 (1.43%) 
Pericardial effusion   1/70 (1.43%) 
Ear and labyrinth disorders   
Ear pain   1/70 (1.43%) 
Eye disorders   
Blurred vision   1/70 (1.43%) 
Eye disorders - Other, specify   2/70 (2.86%) 
Gastrointestinal disorders   
Abdominal Pain   5/70 (7.14%) 
Colitis   1/70 (1.43%) 
Diarrhea   2/70 (2.86%) 
Nausea   2/70 (2.86%) 
General disorders   
Death NOS   1/70 (1.43%) 
Edema limbs   1/70 (1.43%) 
Fatigue   3/70 (4.29%) 
Fever   3/70 (4.29%) 
Gait disturbance   1/70 (1.43%) 
Non-cardiac chest pain   1/70 (1.43%) 
Hepatobiliary disorders   
Cholecystitis   1/70 (1.43%) 
Infections and infestations   
Breast infection   1/70 (1.43%) 
Infections and infestations - other, specify   2/70 (2.86%) 
Sepsis   1/70 (1.43%) 
Skin infection   3/70 (4.29%) 
Injury, poisoning and procedural complications   
Hip fracture   1/70 (1.43%) 
Infusion related reaction   1/70 (1.43%) 
Investigations   
Alanine aminotransferase increased   1/70 (1.43%) 
Aspartate aminotransferase increased   1/70 (1.43%) 
Lipase increased   1/70 (1.43%) 
Serum amylase increased   1/70 (1.43%) 
Metabolism and nutrition disorders   
Anorexia   1/70 (1.43%) 
Dehydration   1/70 (1.43%) 
Hypocalcemia   1/70 (1.43%) 
Hypomagnesemia   1/70 (1.43%) 
Musculoskeletal and connective tissue disorders   
Chest wall pain   1/70 (1.43%) 
Generalized muscle weakness   1/70 (1.43%) 
Muscle weakness lower limb   1/70 (1.43%) 
Musculoskeletal & conn tissue disorder Other, spec   1/70 (1.43%) 
Nervous system disorders   
Dizziness   1/70 (1.43%) 
Edema cerebral   2/70 (2.86%) 
Headache   3/70 (4.29%) 
Hydrocephalus   1/70 (1.43%) 
Nervous system disorders - other, specify   1/70 (1.43%) 
Seizure   2/70 (2.86%) 
Syncope   1/70 (1.43%) 
Psychiatric disorders   
Confusion   1/70 (1.43%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea   2/70 (2.86%) 
Pleural effusion   1/70 (1.43%) 
Pneumothorax   1/70 (1.43%) 
Skin and subcutaneous tissue disorders   
Skin & subcutaneous tissue disorders Other, spec   1/70 (1.43%) 
Vascular disorders   
Hematoma   1/70 (1.43%) 
Hypertension   2/70 (2.86%) 
Hypotension   1/70 (1.43%) 
Thromboembolic event   2/70 (2.86%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pertuzumab in Combination With Trastuzumab and Paclitaxel
Affected / at Risk (%)
Total   67/70 (95.71%) 
Eye disorders   
Xerophthalmia   33/70 (47.14%) 
Epiphora   30/70 (42.86%) 
Gastrointestinal disorders   
Diarrhea   60/70 (85.71%) 
Nausea   42/70 (60.00%) 
Mucositis   37/70 (52.86%) 
Dyspepsia   30/70 (42.86%) 
General disorders   
Fatigue   62/70 (88.57%) 
Peripheral edema   36/70 (51.43%) 
Investigations   
AST/ALT elevation   51/70 (72.86%) 
Metabolism and nutrition disorders   
Anorexia   28/70 (40.00%) 
Musculoskeletal and connective tissue disorders   
Arthralgia   42/70 (60.00%) 
Nervous system disorders   
Peripheral neuropathy   59/70 (84.29%) 
Respiratory, thoracic and mediastinal disorders   
Cough   43/70 (61.43%) 
Epistaxis   29/70 (41.43%) 
Dyspnea   28/70 (40.00%) 
Skin and subcutaneous tissue disorders   
Alopecia   57/70 (81.43%) 
Dry skin   44/70 (62.86%) 
Acneiform rash   38/70 (54.29%) 
Hand-foot syndrome   27/70 (38.57%) 
Vascular disorders   
Hot flashes   36/70 (51.43%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Chau Dang, MD
Organization: Memorial Sloan Kettering Cancer Center
Phone: 914-367-7181
EMail: dangc@mskcc.org
Layout table for additonal information
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01276041    
Other Study ID Numbers: 10-142
First Submitted: January 6, 2011
First Posted: January 13, 2011
Results First Submitted: June 30, 2020
Results First Posted: August 3, 2020
Last Update Posted: August 3, 2020