Status:
COMPLETED
Neoadjuvant Carboplatin, Weekly Abraxane and Trastuzumab in HER2+ Breast Cancer
Lead Sponsor:
William Sikov MD
Collaborating Sponsors:
Yale University
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
Q3week carboplatin with weekly abraxane and trastuzumab as neoadjuvant therapy in resectable and unresectable HER2+ (stage IIa-IIIb) breast cancer
Detailed Description
Our goal is to develop an induction chemotherapy regimen that will have a pCR rate above 50% in HER2+ patients without exposing patients to the toxicity of an anthracycline-based regimen. A minimum of...
Eligibility Criteria
Inclusion
- 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 \< or = ULN
- No evidence of metastatic disease Not pregnant or lactating
- No prior systemic therapy for this breast cancer
- Serum Creatinine \< 1.5 mg/dl or Creat Cl \> 30 ml/min
- Serum ALT \< 2.5 x ULN
- ER, PR and HER2 status required
- LVEF (MUGA/echo)WNL
- No baseline \> 2 neuropathy
- Hemoglobin \> 9.0 gm/dl
- HER2+, defined by IHC 3+ or FISH ratio \> 2.0
Exclusion
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00617942
Start Date
February 1 2008
End Date
December 1 2015
Last Update
June 11 2020
Active Locations (5)
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1
City of Hope
Duarte, California, United States, 91010
2
Yale Smilow Cancer Center
New Haven, Connecticut, United States, 06437
3
Women and Infants Hospital
Providence, Rhode Island, United States, 02903
4
Roger Williams Medical Center
Providence, Rhode Island, United States, 02908