Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments carboplatin, nab-paclitaxel, trastuzumab
Phase phase 2
Target HER2
Sponsor William Sikov
Collaborator Yale University
Start date February 2008
End date August 2012
Trial size 60 participants
Trial identifier NCT00617942, BrUOG-BR-211B

Summary

Q3week carboplatin with weekly abraxane and trastuzumab as neoadjuvant therapy in resectable and unresectable HER2+ (stage IIa-IIIb) breast cancer

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Drug: Carboplatin, Abraxane, Trastuzumab
carboplatin Abraxane (nab-paclitaxel), Herceptin (trastuzumab)
Carboplatin AUC 6
nab-paclitaxel Abraxane (nab-paclitaxel)
Abraxane 100 mg/m2
trastuzumab Herceptin (trastuzumab)
trastuzumab 2 mg/kg

Primary Outcomes

Measure
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;
time frame: 1 year

Secondary Outcomes

Measure
Assess toxicities of regimen during treatment, including grade >2 neurotoxicity the incidence of subclinical and clinical cardiac toxicity
time frame: 1 year

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

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
Principal investigator William Sikov, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by Brown University.