Neoadjuvant Carboplatin, Weekly Abraxane and Trastuzumab in HER2+ Breast Cancer - Full Text View

Sponsors and Collaborators:	Brown University Yale University
Information provided by:	Brown University
ClinicalTrials.gov Identifier:	NCT00617942

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 II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
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:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Paclitaxel Carboplatin Trastuzumab

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 ]

Estimated Enrollment:	60
Study Start Date:	February 2008
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Phase II: Experimental Drug: Carboplatin, Abraxane, Trastuzumab	Drug: Carboplatin Carboplatin AUC 6 Drug: nab-paclitaxel Abraxane 100 mg/m2 Drug: trastuzumab trastuzumab 2 mg/kg

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

Contacts

Contact: Teresa A Kennedy, RN,CCRA	401-383-3000	Teresa_Kennedy@Brown.edu
Contact: william Sikov, MD	401-793-7151	WSikov@Lifespan.org

Locations

United States, Rhode Island
Brown University Oncology Group	Recruiting
Providence, Rhode Island, United States, 02912
Principal Investigator: William Sikov, MD

Sponsors and Collaborators

Brown University

Yale University

Investigators

Principal Investigator:

William Sikov, MD

Brown University

More Information

No publications provided

Responsible Party:	Miriam Hospital ( Dr. William Sikov )
Study ID Numbers:	BrUOG-BR-211B
Study First Received:	February 6, 2008
Last Updated:	January 27, 2009
ClinicalTrials.gov Identifier:	NCT00617942 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Brown University:

Breast Cancer

Study placed in the following topic categories:

Skin Diseases
Paclitaxel
Tubulin Modulators
Trastuzumab
Breast Neoplasms

Antimitotic Agents
Carboplatin
Antineoplastic Agents, Phytogenic
Breast Diseases

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Skin Diseases
Antineoplastic Agents
Mitosis Modulators
Breast Neoplasms
Carboplatin
Antimitotic Agents
Pharmacologic Actions

Neoplasms
Neoplasms by Site
Paclitaxel
Therapeutic Uses
Tubulin Modulators
Trastuzumab
Antineoplastic Agents, Phytogenic
Breast Diseases

ClinicalTrials.gov processed this record on September 10, 2009