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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

Page last updated: August 20, 2015

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