Neoadjuvant Carboplatin, Weekly Abraxane and Trastuzumab in HER2+ Breast Cancer
Information source: Brown University
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer
Intervention: Carboplatin (Drug); nab-paclitaxel (Drug); trastuzumab (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: William Sikov Official(s) and/or principal investigator(s): William Sikov, MD, Principal Investigator, Affiliation: Brown University
Summary
Q3week carboplatin with weekly abraxane and trastuzumab as neoadjuvant therapy in resectable
and unresectable HER2+ (stage IIa-IIIb) breast cancer
Clinical Details
Official title: BrUOG-BR-211B q3week Carboplatin With Weekly Abraxane and Trastuzumab As Neoadjuvant Therapy in Resectable and Unresectable HER2+ (Stage IIa-IIIb) Breast Cancer
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: To determine the clinical and pathologic response rates, particularly the pCR/near pCR rate, observed following treatment with q3week carboplatin, weekly Abraxane and weekly trastuzumab in resectable and unresectable LABC;
Secondary outcome: Assess toxicities of regimen during treatment, including grade >2 neurotoxicity the incidence of subclinical and clinical cardiac toxicity
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 60 evaluable patients will be accrued to the study. We are assuming
an observed pCR (or near pCR) rate of 70%. Assuming no more than 10% of patients will be
inevaluable for the primary endpoint (pCR), we will have at least 54 evaluable patients.
With this number, we will have 90% power, with a 1-sided alpha error of 0. 05, to demonstrate
a pCR rate exceeding 50% for our novel regimen.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
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 < 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
Locations and Contacts
City of Hope, Duarte, California 91010, United States
Yale Smilow Cancer Center, New Haven, Connecticut 06437, United States
Rhode Island and The Miriam Hospital, Providence, Rhode Island 02912, United States
Roger Williams Medical Center, Providence, Rhode Island 02908, United States
Women and Infants Hospital, Providence, Rhode Island 02903, United States
Additional Information
Starting date: February 2008
Last updated: July 15, 2014
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