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Trastuzumab and Pertuzumab or Bevacizumab With Combination Chemotherapy in Treating Patients With Stage II-III Breast Cancer

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ClinicalTrials.gov Identifier: NCT01959490
Recruitment Status : Completed
First Posted : October 10, 2013
Results First Posted : March 5, 2019
Last Update Posted : March 5, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Conditions Stage II Breast Cancer
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Interventions Biological: trastuzumab
Biological: Pertuzumab
Drug: docetaxel
Drug: carboplatin
Drug: doxorubicin
Drug: cyclophosphamide
Drug: paclitaxel
Drug: Bevacizumab
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cohort 1P (HER2 Positive) Cohort 1T (HER2 Positive) Cohort II (HER2 Negative)
Hide Arm/Group Description Patients receive a run-in Pertuzumab treatment of 840 mg IV over 60 minutes on day -14 followed by Trastuzumab IV over 30-60 minutes and Pertuzumab IV over 30-60 minutes, docetaxel IV, and carboplatin IV on day 1. Treatment repeats very 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients receive a run-in Trastuzumab treatment of 8 mg/kg IV over 90 minutes on day -14 followed by Trastuzumab IV over 30-60 minutes and Pertuzumab IV over 30-60 minutes, Docetaxel IV, and Carboplatin IV on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients receive Bevacizumab IV over 30-60 minutes on day 1 of weeks

1, 3, 5, 7, 9, and 11; Doxorubicin IV and Cyclophosphamide IV over 30-60 minutes on day 1 of weeks 1, 3, 5, and 7; and Paclitaxel IV over 3 hours on day 1 of weeks 9, 11, 13, and 15.

Period Title: Overall Study
Started 5 6 5
Completed 5 6 5
Not Completed 0 0 0
Arm/Group Title Cohort 1P (HER2 Positive) Cohort 1T (HER2 Positive) Cohort II (HER2 Negative) Total
Hide Arm/Group Description Patients receive a run-in Pertuzumab treatment of 840 mg IV over 60 minutes on day -14 followed by Trastuzumab IV over 30-60 minutes and Pertuzumab IV over 30-60 minutes, docetaxel IV, and carboplatin IV on day 1. Treatment repeats very 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity Patients receive a run-in Trastuzumab treatment of 8 mg/kg IV over 90 minutes on day -14 followed by Trastuzumab IV over 30-60 minutes and Pertuzumab IV over 30-60 minutes, Docetaxel IV, and Carboplatin IV on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients receive Bevacizumab IV over 30-60 minutes on day 1 of weeks 1, 3, 5, 7, 9, and 11; Doxorubicin IV and Cyclophosphamide IV over 30-60 minutes on day 1 of weeks 1, 3, 5, and 7; and Paclitaxel IV over 3 hours on day 1 of weeks 9, 11, 13, and 15. Total of all reporting groups
Overall Number of Baseline Participants 5 6 5 16
Hide Baseline Analysis Population Description
All participants enrolled in study
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 6 participants 5 participants 16 participants
30-39 years
0
   0.0%
1
  16.7%
0
   0.0%
1
   6.3%
40-49 years
1
  20.0%
2
  33.3%
1
  20.0%
4
  25.0%
50-59 years
3
  60.0%
1
  16.7%
0
   0.0%
4
  25.0%
60-69 years
0
   0.0%
1
  16.7%
4
  80.0%
5
  31.3%
70-79 years
1
  20.0%
1
  16.7%
0
   0.0%
2
  12.5%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 6 participants 5 participants 16 participants
Female
5
 100.0%
6
 100.0%
5
 100.0%
16
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 6 participants 5 participants 16 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
5
 100.0%
6
 100.0%
5
 100.0%
16
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 6 participants 5 participants 16 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
  20.0%
2
  33.3%
0
   0.0%
3
  18.8%
White
4
  80.0%
4
  66.7%
5
 100.0%
13
  81.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants 6 participants 5 participants 16 participants
5 6 5 16
1.Primary Outcome
Title Number of Patients With a Pathological Complete Response (pCR) Who Received Targeted Therapy With Trastuzumab and Pertuzumab or Bevacizumab Predicted by Genomically-derived Molecular Subtypes.
Hide Description Number of patients with a pathological complete response (pCR) who received targeted therapy with trastuzumab and pertuzumab or bevacizumab predicted by genomically-derived molecular subtypes (HER2 positive or HER2 negative. pCR is defined as absence of invasive cancer in breast or lymph nodes after neoadjuvant chemotherapy.
Time Frame Up to 30 days after last cycle of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All participants enrolled in study and who received treatment.
Arm/Group Title Cohort 1P (HER2 Positive) Cohort 1T (HER2 Positive) Cohort II (HER2 Negative)
Hide Arm/Group Description:
Patients receive a run-in Pertuzumab treatment of 840 mg IV over 60 minutes on day -14 followed by Trastuzumab IV over 30-60 minutes and Pertuzumab IV over 30-60 minutes, docetaxel IV, and carboplatin IV on day 1. Treatment repeats very 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
Patients receive a run-in Trastuzumab treatment of 8 mg/kg IV over 90 minutes on day -14 followed by Trastuzumab IV over 30-60 minutes and Pertuzumab IV over 30-60 minutes, Docetaxel IV, and Carboplatin IV on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients receive Bevacizumab IV over 30-60 minutes on day 1 of weeks

1, 3, 5, 7, 9, and 11; Doxorubicin IV and Cyclophosphamide IV over 30-60 minutes on day 1 of weeks 1, 3, 5, and 7; and Paclitaxel IV over 3 hours on day 1 of weeks 9, 11, 13, and 15.

Overall Number of Participants Analyzed 5 6 5
Measure Type: Count of Participants
Unit of Measure: Participants
4
  80.0%
6
 100.0%
3
  60.0%
2.Secondary Outcome
Title The Number of HER2 Positive Patients With a Pathological Complete Response (pCR) Predicted by a Trastuzumab and Pertuzumab Response Signature
Hide Description [Not Specified]
Time Frame Up to 30 days after last cycle of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected
Arm/Group Title Cohort 1P (HER2 Positive) Cohort 1T (HER2 Positive) Cohort II (HER2 Negative)
Hide Arm/Group Description:
Patients receive a run-in Pertuzumab treatment of 840 mg IV over 60 minutes on day -14 followed by Trastuzumab IV over 30-60 minutes and Pertuzumab IV over 30-60 minutes, docetaxel IV, and carboplatin IV on day 1. Treatment repeats very 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
Patients receive a run-in Trastuzumab treatment of 8 mg/kg IV over 90 minutes on day -14 followed by Trastuzumab IV over 30-60 minutes and Pertuzumab IV over 30-60 minutes, Docetaxel IV, and Carboplatin IV on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients receive Bevacizumab IV over 30-60 minutes on day 1 of weeks

1, 3, 5, 7, 9, and 11; Doxorubicin IV and Cyclophosphamide IV over 30-60 minutes on day 1 of weeks 1, 3, 5, and 7; and Paclitaxel IV over 3 hours on day 1 of weeks 9, 11, 13, and 15.

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title The Number of HER2 Negative Patients With a pCR Predicted by the TGF-B Response Signature
Hide Description [Not Specified]
Time Frame Up to 30 days after last cycle of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected
Arm/Group Title Cohort 1P (HER2 Positive) Cohort 1T (HER2 Positive) Cohort II (HER2 Negative)
Hide Arm/Group Description:
Patients receive a run-in Pertuzumab treatment of 840 mg IV over 60 minutes on day -14 followed by Trastuzumab IV over 30-60 minutes and Pertuzumab IV over 30-60 minutes, docetaxel IV, and carboplatin IV on day 1. Treatment repeats very 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
Patients receive a run-in Trastuzumab treatment of 8 mg/kg IV over 90 minutes on day -14 followed by Trastuzumab IV over 30-60 minutes and Pertuzumab IV over 30-60 minutes, Docetaxel IV, and Carboplatin IV on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients receive Bevacizumab IV over 30-60 minutes on day 1 of weeks

1, 3, 5, 7, 9, and 11; Doxorubicin IV and Cyclophosphamide IV over 30-60 minutes on day 1 of weeks 1, 3, 5, and 7; and Paclitaxel IV over 3 hours on day 1 of weeks 9, 11, 13, and 15.

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title The Number of HER2 Positive Patients With a pCR Predicted by the AKT Signature and IGF Signature.
Hide Description [Not Specified]
Time Frame Up to 30 days after last cycle of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected
Arm/Group Title Cohort 1P (HER2 Positive) Cohort 1T (HER2 Positive) Cohort II (HER2 Negative)
Hide Arm/Group Description:
Patients receive a run-in Pertuzumab treatment of 840 mg IV over 60 minutes on day -14 followed by Trastuzumab IV over 30-60 minutes and Pertuzumab IV over 30-60 minutes, docetaxel IV, and carboplatin IV on day 1. Treatment repeats very 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
Patients receive a run-in Trastuzumab treatment of 8 mg/kg IV over 90 minutes on day -14 followed by Trastuzumab IV over 30-60 minutes and Pertuzumab IV over 30-60 minutes, Docetaxel IV, and Carboplatin IV on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients receive Bevacizumab IV over 30-60 minutes on day 1 of weeks

1, 3, 5, 7, 9, and 11; Doxorubicin IV and Cyclophosphamide IV over 30-60 minutes on day 1 of weeks 1, 3, 5, and 7; and Paclitaxel IV over 3 hours on day 1 of weeks 9, 11, 13, and 15.

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title The Number of Patients With a pCR Predicated by Copy Number Alterations.
Hide Description [Not Specified]
Time Frame Up to 30 days after last cycle of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected
Arm/Group Title Cohort 1P (HER2 Positive) Cohort 1T (HER2 Positive) Cohort II (HER2 Negative)
Hide Arm/Group Description:
Patients receive a run-in Pertuzumab treatment of 840 mg IV over 60 minutes on day -14 followed by Trastuzumab IV over 30-60 minutes and Pertuzumab IV over 30-60 minutes, docetaxel IV, and carboplatin IV on day 1. Treatment repeats very 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
Patients receive a run-in Trastuzumab treatment of 8 mg/kg IV over 90 minutes on day -14 followed by Trastuzumab IV over 30-60 minutes and Pertuzumab IV over 30-60 minutes, Docetaxel IV, and Carboplatin IV on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients receive Bevacizumab IV over 30-60 minutes on day 1 of weeks

1, 3, 5, 7, 9, and 11; Doxorubicin IV and Cyclophosphamide IV over 30-60 minutes on day 1 of weeks 1, 3, 5, and 7; and Paclitaxel IV over 3 hours on day 1 of weeks 9, 11, 13, and 15.

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title The Number of Patients With a pCR Predicted by Changes in Texture on Breast DCE-MRI After a Two-week “run-in” Treatment With Trastuzumab, Pertuzumab, or Bevacizumab
Hide Description Determine if changes in regularity and entropy range predict pCR and in an exploratory fashion determine if specific texture features exist in each molecular subtype that predict pCR.
Time Frame At 2 weeks after start of run-in period
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected
Arm/Group Title Cohort 1P (HER2 Positive) Cohort 1T (HER2 Positive) Cohort II (HER2 Negative)
Hide Arm/Group Description:
Patients receive a run-in Pertuzumab treatment of 840 mg IV over 60 minutes on day -14 followed by Trastuzumab IV over 30-60 minutes and Pertuzumab IV over 30-60 minutes, docetaxel IV, and carboplatin IV on day 1. Treatment repeats very 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
Patients receive a run-in Trastuzumab treatment of 8 mg/kg IV over 90 minutes on day -14 followed by Trastuzumab IV over 30-60 minutes and Pertuzumab IV over 30-60 minutes, Docetaxel IV, and Carboplatin IV on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients receive Bevacizumab IV over 30-60 minutes on day 1 of weeks

1, 3, 5, 7, 9, and 11; Doxorubicin IV and Cyclophosphamide IV over 30-60 minutes on day 1 of weeks 1, 3, 5, and 7; and Paclitaxel IV over 3 hours on day 1 of weeks 9, 11, 13, and 15.

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Other Pre-specified Outcome
Title Descriptive Statistics of PET/CT Scan
Hide Description Qualitative and quantitative image analysis will be performed and descriptively summarized. For the 10 patients in the PET/CT sub-study of cohort 1.
Time Frame Up to 30 days after last cycle of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Outcome not determined because low accrual prevented appropriate analysis and calculation of the prediction measure.
Arm/Group Title Cohort 1P (HER2 Positive) Cohort 1T (HER2 Positive) Cohort II (HER2 Negative)
Hide Arm/Group Description:
Patients receive a run-in Pertuzumab treatment of 840 mg IV over 60 minutes on day -14 followed by Trastuzumab IV over 30-60 minutes and Pertuzumab IV over 30-60 minutes, docetaxel IV, and carboplatin IV on day 1. Treatment repeats very 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
Patients receive a run-in Trastuzumab treatment of 8 mg/kg IV over 90 minutes on day -14 followed by Trastuzumab IV over 30-60 minutes and Pertuzumab IV over 30-60 minutes, Docetaxel IV, and Carboplatin IV on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients receive Bevacizumab IV over 30-60 minutes on day 1 of weeks

1, 3, 5, 7, 9, and 11; Doxorubicin IV and Cyclophosphamide IV over 30-60 minutes on day 1 of weeks 1, 3, 5, and 7; and Paclitaxel IV over 3 hours on day 1 of weeks 9, 11, 13, and 15.

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Up to 30 days after last cycle of treatment
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cohort 1P (HER2 Positive) Cohort 1T (HER2 Positive) Cohort II (HER2 Negative)
Hide Arm/Group Description Patients receive a run-in Pertuzumab treatment of 840 mg IV over 60 minutes on day -14 followed by Trastuzumab IV over 30-60 minutes and Pertuzumab IV over 30-60 minutes, docetaxel IV, and carboplatin IV on day 1. Treatment repeats very 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients receive a run-in Trastuzumab treatment of 8 mg/kg IV over 90 minutes on day -14 followed by Trastuzumab IV over 30-60 minutes and Pertuzumab IV over 30-60 minutes, Docetaxel IV, and Carboplatin IV on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients receive Bevacizumab IV over 30-60 minutes on day 1 of weeks

1, 3, 5, 7, 9, and 11; Doxorubicin IV and Cyclophosphamide IV over 30-60 minutes on day 1 of weeks 1, 3, 5, and 7; and Paclitaxel IV over 3 hours on day 1 of weeks 9, 11, 13, and 15.

All-Cause Mortality
Cohort 1P (HER2 Positive) Cohort 1T (HER2 Positive) Cohort II (HER2 Negative)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Cohort 1P (HER2 Positive) Cohort 1T (HER2 Positive) Cohort II (HER2 Negative)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/5 (20.00%)      0/6 (0.00%)      1/5 (20.00%)    
Blood and lymphatic system disorders       
Anemia * 1  0/5 (0.00%)  0 0/6 (0.00%)  0 1/5 (20.00%)  1
Febrile neutropenia * 1  0/5 (0.00%)  0 0/6 (0.00%)  0 1/5 (20.00%)  1
Gastrointestinal disorders       
Diarrhea * 1  1/5 (20.00%)  1 0/6 (0.00%)  0 0/5 (0.00%)  0
Investigations       
Neutrophil count decreased * 1  0/5 (0.00%)  0 0/6 (0.00%)  0 1/5 (20.00%)  1
White blood cell decreased * 1  0/5 (0.00%)  0 0/6 (0.00%)  0 1/5 (20.00%)  1
Nervous system disorders       
Syncope * 1  1/5 (20.00%)  1 0/6 (0.00%)  0 0/5 (0.00%)  0
Vascular disorders       
Hypotension * 1  1/5 (20.00%)  1 0/6 (0.00%)  0 0/5 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE v4.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cohort 1P (HER2 Positive) Cohort 1T (HER2 Positive) Cohort II (HER2 Negative)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/5 (100.00%)      3/6 (50.00%)      4/5 (80.00%)    
Blood and lymphatic system disorders       
Anemia * 1  1/5 (20.00%)  1 0/6 (0.00%)  0 0/5 (0.00%)  0
Cardiac disorders       
Sinus tachycardia * 1  1/5 (20.00%)  1 0/6 (0.00%)  0 0/5 (0.00%)  0
Ventricular tachycardia * 1  0/5 (0.00%)  0 1/6 (16.67%)  1 0/5 (0.00%)  0
Ear and labyrinth disorders       
Hearing impaired * 1  0/5 (0.00%)  0 0/6 (0.00%)  0 1/5 (20.00%)  1
Infections and infestations       
Urinary tract infection * 1  1/5 (20.00%)  1 0/6 (0.00%)  0 0/5 (0.00%)  0
Investigations       
Lymphocyte count decreased * 1  1/5 (20.00%)  1 2/6 (33.33%)  2 2/5 (40.00%)  7
Neutrophil count decreased * 1  1/5 (20.00%)  1 0/6 (0.00%)  0 1/5 (20.00%)  1
Weight loss * 1  1/5 (20.00%)  1 0/6 (0.00%)  0 0/5 (0.00%)  0
White blood cell decreased * 1  1/5 (20.00%)  1 0/6 (0.00%)  0 3/5 (60.00%)  4
Metabolism and nutrition disorders       
Hypokalemia * 1  0/5 (0.00%)  0 1/6 (16.67%)  1 0/5 (0.00%)  0
Vascular disorders       
Hypertension * 1  2/5 (40.00%)  8 3/6 (50.00%)  6 1/5 (20.00%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE v4.0
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Paula Silverman
Organization: Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Phone: 1-800-641-2422
Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01959490     History of Changes
Other Study ID Numbers: CASE14112
NCI-2013-01422 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CASE 14112 ( Other Identifier: Case Comprehensive Cancer Center )
P30CA043703 ( U.S. NIH Grant/Contract )
First Submitted: August 16, 2013
First Posted: October 10, 2013
Results First Submitted: January 8, 2019
Results First Posted: March 5, 2019
Last Update Posted: March 5, 2019