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Preoperative Cisplatin and Bevacizumab in ER-, PR-, HER2 Negative Breast Cancer

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ClinicalTrials.gov Identifier: NCT00580333
Recruitment Status : Completed
First Posted : December 24, 2007
Results First Posted : March 31, 2017
Last Update Posted : May 26, 2021
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Genentech, Inc.
Information provided by (Responsible Party):
Steven J Isakoff, MD, PhD, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Drug: cisplatin
Drug: bevacizumab
Drug: doxorubicin
Drug: cyclophosphamide
Drug: paclitaxel
Enrollment 51
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cisplatin/Avastin
Hide Arm/Group Description

cisplatin: Preoperatively: Given intravenously on day one of the treatment cycle (once every 3 weeks) for four cycles

bevacizumab: Preoperatively: Given intravenously on day 1 of the treatment cycle (once every three weeks) for three cycles Postoperatively: Intravenously for four 2-week cycles (once every two weeks) and after the 8 weeks (study doctor will determine course of treatment) for an additional four 2-week cycles with or with out paclitaxel

doxorubicin: Postoperative: Given intravenously for four 2-week cycles

cyclophosphamide: Postoperative: Given intravenously for four two-week cycles

paclitaxel: Postoperative: 8 weeks after postoperative chemotherapy regimen (study doctor will determine course of treatment) paclitaxel for four 2-week cycles (once every two weeks)

Period Title: Overall Study
Started 51
Completed 51
Not Completed 0
Arm/Group Title Cisplatin/Avastin
Hide Arm/Group Description

Cisplatin 75mg/m2 every 3 weeks, neoadjuvant bevacizumab 15mg/m2 every 3 weeks, neoadjuvant doxorubicin, adjuvant (optional) cyclophosphamide , adjuvant (optional) paclitaxel, adjuvant (optional)

cisplatin: Preoperatively: Given intravenously on day one of the treatment cycle (once every 3 weeks) for four cycles

bevacizumab: Preoperatively: Given IV on day 1 of the treatment cycle (once every three weeks) for three cycles Postoperatively: Intravenously for four 2-week cycles (once every two weeks) and after the 8 weeks (study doctor will determine course of treatment) for an additional four 2-week cycles with or with out paclitaxel

doxorubicin: Postoperative: Given intravenously for four 2-week cycles

cyclophosphamide: Postoperative: Given intravenously for four two-week cycles

paclitaxel: Postoperative: 8 weeks after postoperative chemotherapy regimen (study doctor will determine course of treatment) paclitaxel for four 2-week cycles (once every two weeks)

Overall Number of Baseline Participants 51
Hide Baseline Analysis Population Description
stage 2 or 3 triple negative breast cancer
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 51 participants
50
(30 to 66)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants
<=18 years
0
   0.0%
Between 18 and 65 years
50
  98.0%
>=65 years
1
   2.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants
Female
51
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 51 participants
51
1.Primary Outcome
Title Pathologic Complete Response Rate After Preoperative Therapy With Cisplatin and Bevacizumab in ER-, PR-, Human Epidermal Growth Factor Receptor 2 (HER2) -Negative Early Breast Cancer.
Hide Description The goal of this measure was to determine the pathologic complete response rate (Miller-Payne (MP) score 5) after preoperative therapy with cisplatin and bevacizumab in ER-, PR-, HER2-negative early breast cancer.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cisplatin/Avastin
Hide Arm/Group Description:

Cisplatin 75mg/m2 every 3 weeks, neoadjuvant bevacizumab 15mg/m2 every 3 weeks, neoadjuvant doxorubicin, adjuvant (optional) cyclophosphamide , adjuvant (optional) paclitaxel, adjuvant (optional)

cisplatin: Preoperatively: Given intravenously on day one of the treatment cycle (once every 3 wks) for four cycles

bevacizumab: Preoperatively: Given intravenously on day 1 of the treatment cycle (once every three wks) for three cycles Postoperatively: Intravenously for four 2-week cycles (once every two weeks) and after the 8 weeks (study doctor will determine course of treatment) for an additional four 2-week cycles with or with out paclitaxel

doxorubicin: Postoperative: Given intravenously for four 2-week cycles

cyclophosphamide: Postoperative: Given intravenously for four two-week cycles

paclitaxel: Postoperative: 8 weeks after postoperative chemotherapy regimen (study doctor will determine course of treatment) paclitaxel for four 2-week cycles (once every two week

Overall Number of Participants Analyzed 51
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
16
(7 to 29)
2.Secondary Outcome
Title Clinical Overall and Complete Response Rates After Preoperative Therapy With Cisplatin and Bevacizumab
Hide Description 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 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cisplatin/Avastin
Hide Arm/Group Description:

Cisplatin 75mg/m2 every 3 weeks, neoadjuvant bevacizumab 15mg/m2 every 3 weeks, neoadjuvant doxorubicin, adjuvant (optional), cyclophosphamide , adjuvant (optional), paclitaxel, adjuvant (optional)

cisplatin: Preoperatively: Given intravenously on day one of the treatment cycle (once every 3 weeks) for four cycles

bevacizumab: Preoperatively: Given intravenously on day 1 of the treatment cycle (once every 3 weeks) for 3 cycles Postoperatively: Intravenously for four 2-week cycles (once every two weeks) and after the 8 weeks (study doctor will determine course of treatment) for an additional four 2-week cycles with or with out paclitaxel

doxorubicin: Postoperative: Given intravenously for four 2-week cycles

cyclophosphamide: Postoperative: Given intravenously for four two-week cycles

paclitaxel: Postoperative: 8 weeks after postoperative chemotherapy regimen (study doctor will determine course of treatment) paclitaxel for four 2-week cycles (once every two week

Overall Number of Participants Analyzed 51
Measure Type: Count of Participants
Unit of Measure: Participants
CR
12
  23.5%
OR = CR+PR
39
  76.5%
3.Secondary Outcome
Title Toxicity of Administering Bevacizumab in Combination With Standard Adjuvant Chemotherapy.
Hide Description Number of patients who were unable to receive all cycles of chemotherapy on time for toxicity reasons.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
analyzed the 43 patients who completed 4 cycles of neoadjuvant therapy and started post-operative treatment
Arm/Group Title Cisplatin/Avastin
Hide Arm/Group Description:

Cisplatin 75mg/m2 every 3 weeks, neoadjuvant bevacizumab 15mg/m2 every 3 weeks, neoadjuvant doxorubicin, adjuvant (optional), cyclophosphamide , adjuvant (optional), paclitaxel, adjuvant (optional)

cisplatin: Preoperatively: Given intravenously on day one of the treatment cycle (once every 3 weeks) for four cycles

bevacizumab: Preoperatively: Given intravenously on day 1 of the treatment cycle (once every 3 weeks) for 3 cycles Postoperatively: Intravenously for four 2-week cycles (once every two weeks) and after the 8 weeks (study doctor will determine course of treatment) for an additional four 2-week cycles with or with out paclitaxel

doxorubicin: Postoperative: Given intravenously for four 2-week cycles

cyclophosphamide: Postoperative: Given intravenously for four two-week cycles

paclitaxel: Postoperative: 8 weeks after postoperative chemotherapy regimen (study doctor will determine course of treatment) paclitaxel for four 2-week cycles (once every two week

Overall Number of Participants Analyzed 43
Measure Type: Count of Participants
Unit of Measure: Participants
8
  18.6%
4.Secondary Outcome
Title Patients With Miller-Payne (MP) Score 3, 4, or 5 Response
Hide Description To describe a panel of molecular assays for an association with clinical response and, if feasible, with pathologic complete response (pCR) in ER-, PR-, HER2-negative subjects treated with cisplatin and bevacizumab in the preoperative setting. A Miller-Payne (MP) score of 3 indicates a decrease in the size of the cancer by 30% to 90%. A MP score of 4 indicates marked decrease in the size of the cancer by greater than 90%. A MP score of 5 indicates there is no residual cancer remaining (the same as a pathologic complete response).
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cisplatin/Avastin
Hide Arm/Group Description:

Cisplatin 75mg/m2 every 3 weeks, neoadjuvant bevacizumab 15mg/m2 every 3 weeks, neoadjuvant doxorubicin, adjuvant (optional), cyclophosphamide , adjuvant (optional), paclitaxel, adjuvant (optional)

cisplatin: Preoperatively: Given intravenously on day one of the treatment cycle (once every 3 weeks) for four cycles

bevacizumab: Preoperatively: Given intravenously on day 1 of the treatment cycle (once every 3 weeks) for 3 cycles Postoperatively: Intravenously for four 2-week cycles (once every two weeks) and after the 8 weeks (study doctor will determine course of treatment) for an additional four 2-week cycles with or with out paclitaxel

doxorubicin: Postoperative: Given intravenously for four 2-week cycles

cyclophosphamide: Postoperative: Given intravenously for four two-week cycles

paclitaxel: Postoperative: 8 weeks after postoperative chemotherapy regimen (study doctor will determine course of treatment) paclitaxel for four 2-week cycles (once every two week

Overall Number of Participants Analyzed 51
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
45
(31 to 60)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cisplatin/Avastin
Hide Arm/Group Description

Cisplatin 75mg/m2 every 3 weeks, neoadjuvant bevacizumab 15mg/m2 every 3 weeks, neoadjuvant doxorubicin, adjuvant (optional) cyclophosphamide , adjuvant (optional) paclitaxel, adjuvant (optional)

cisplatin: Preoperatively: Given intravenously on day one of the treatment cycle (once every 3 wks) for four cycles

bevacizumab: Preoperatively: Given intravenously on day 1 of the treatment cycle (once every three wks) for three cycles Postoperatively: Intravenously for four 2-week cycles (once every two weeks) and after the 8 weeks (study doctor will determine course of treatment) for an additional four 2-week cycles with or with out paclitaxel

doxorubicin: Postoperative: Given intravenously for four 2-week cycles

cyclophosphamide: Postoperative: Given intravenously for four two-week cycles

paclitaxel: Postoperative: 8 weeks after postoperative chemotherapy regimen (study doctor will determine course of treatment) paclitaxel for four 2-week cycles (once every two week

All-Cause Mortality
Cisplatin/Avastin
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Cisplatin/Avastin
Affected / at Risk (%)
Total   0/51 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cisplatin/Avastin
Affected / at Risk (%)
Total   51/51 (100.00%) 
Gastrointestinal disorders   
nausea   35/51 (68.63%) 
General disorders   
fatigue   36/51 (70.59%) 
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. Steven Isakoff
Organization: Massachusetts General Hospital
Phone: 617 726 6500
EMail: sisakoff@partners.org
Layout table for additonal information
Responsible Party: Steven J Isakoff, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00580333    
Other Study ID Numbers: 06-202
AVF36335 ( Other Identifier: Genentech )
First Submitted: December 20, 2007
First Posted: December 24, 2007
Results First Submitted: April 2, 2014
Results First Posted: March 31, 2017
Last Update Posted: May 26, 2021