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Neoadjuvant Carboplatin, Weekly Abraxane and Trastuzumab in HER2+ Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Yale University
Information provided by (Responsible Party):
William Sikov, Brown University
ClinicalTrials.gov Identifier:
NCT00617942
First received: February 6, 2008
Last updated: April 21, 2013
Last verified: April 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Breast Cancer
 Drug: Carboplatin
Drug: nab-paclitaxel
Drug: trastuzumab
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Brown University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess toxicities of regimen during treatment, including grade >2 neurotoxicity the incidence of subclinical and clinical cardiac toxicity [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: February 2008
Estimated Study Completion Date: December 2017
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phase II
Drug: Carboplatin, Abraxane, Trastuzumab
 Drug: Carboplatin
Carboplatin AUC 6
Other Name: Abraxane (nab-paclitaxel), Herceptin (trastuzumab)
Drug: nab-paclitaxel
Abraxane 100 mg/m2
Other Name: Abraxane (nab-paclitaxel)
Drug: trastuzumab
trastuzumab 2 mg/kg
Other Name: Herceptin (trastuzumab)

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00617942

Locations
United States, California
City of Hope
Duarte, California, United States, 91010
United States, Rhode Island
Brown University Oncology Group
Providence, Rhode Island, United States, 02912
Sponsors and Collaborators
William Sikov
Yale University
Investigators
Principal Investigator: William Sikov, MD Brown University
  More Information

No publications provided

Responsible Party: William Sikov, Principle Investigator, Brown University
ClinicalTrials.gov Identifier: NCT00617942     History of Changes
Other Study ID Numbers: BrUOG-BR-211B
Study First Received: February 6, 2008
Last Updated: April 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Brown University:
Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Carboplatin
Paclitaxel
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on June 17, 2013