Status:
COMPLETED
Carboplatin, Abraxane, Avastin as Neoadjuvant Therapy for Her2-Negative Breast Cancer
Lead Sponsor:
William Sikov MD
Collaborating Sponsors:
Yale University
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
In the MDACC/BrUOG neoadjuvant trial with weekly paclitaxel followed by Fluorouracil Plus Doxorubicin and Cyclophosphamide (FAC), the pathologic complete response (pCR) rate in HER2(-) patients was 20...
Detailed Description
See above brief summary
Eligibility Criteria
Inclusion
- Eligibility criteria
- Inclusion criteria:
- Histologically documented adenocarcinoma of the breast
- ANC \> 1000 cells
- Female; age \> 18
- Zubrod PS 0-1
- Platelets \> 100,000
- Stage IIA-IIIB disease
- Total bilirubin \< 1.5 ULN
- No evidence of any metastatic disease
- Serum Creatinine \< 1.5 gm/dl
- No prior systemic therapy for breast cancer or Creat Cl \> 30 ml/min
- Not pregnant or lactating
- Serum ALT \< 2.0 ULN
- ER, PR and HER2 status required
- LVEF (MUGA/echo WNL)
- No baseline \> 2 neuropathy
- Urine protein: creat ratio \< 1.0
- HER2-negative - either IHC 0-1+ or FISH ratio \< 2.0
- Hemoglobin \> 9 gm/dl
- (FISH testing is required for all HER2 2-3+ tumors by IHC)
- Exclusion criteria:
- No Histologically documented adenocarcinoma of the breast
- No-ANC \> 1000 cells
- Female; age \< 18
- Zubrod PS \> 0-1
- Platelets \< 100,000
- Stage IV disease
- Total bilirubin \> 1.5 ULN
- metastatic disease
- Serum Creatinine \> 1.5 gm/dl
- prior systemic therapy for breast cancer or Creat Cl \> 30 ml/min
- pregnant or lactating
- Serum ALT \> 2.0 ULN baseline \> 2 neuropathy
- Urine protein: creat ratio \>1.0
- HER2-positive
- Hemoglobin \< 9 gm/dl
Exclusion
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 15 2014
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00723125
Start Date
September 1 2008
End Date
May 15 2014
Last Update
April 29 2021
Active Locations (5)
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1
Bridgeport Hospital
Bridgeport, Connecticut, United States, 06610
2
Yale Smilow Cancer Center
New Haven, Connecticut, United States, 06519
3
Rhode Island Hsopital
Providence, Rhode Island, United States, 02903
4
Women and Infants
Providence, Rhode Island, United States, 02905