Docetaxel and Carboplatin With or Without Trastuzumab Before Surgery in Treating Women With Locally Advanced Breast Cancer - Full Text View

Sponsor:	University of California, Los Angeles
Collaborators:	National Cancer Institute (NCI) Aventis Pharmaceuticals Genentech
Information provided by:	University of California, Los Angeles
ClinicalTrials.gov Identifier:	NCT00068341

Purpose

RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether docetaxel and carboplatin are more effective with or without trastuzumab in treating breast cancer.

PURPOSE: This randomized phase II trial is studying how well giving docetaxel together with carboplatin and trastuzumab before surgery works compared to docetaxel and carboplatin alone before surgery in treating women with locally advanced breast cancer.

Condition	Intervention	Phase
Breast Cancer	Biological: trastuzumab Drug: carboplatin Drug: docetaxel	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Neoadjuvant Treatment and Molecular Characterization of Locally Advanced Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Carboplatin Docetaxel Trastuzumab

U.S. FDA Resources

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:

Evaluate the objective response rate of patients treated with Taxotere/carboplatin with or without Herceptin preoperatively. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Establish profiles of biomarkers that predict chemoresponsiveness of tumors, using methods for conventional pathology studies and experimental molecular analysis. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
To establish profiles of angiogenic mediators of locally advanced breast cancer and its impact in drug response and prognosis. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Study the role of HER-2/neu and LRP/major vault protein in chemotherapy-induced tumor response [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Determine unique gene expression patterns of responder and nonresponder tumors to the prescribed neoadjuvant chemotherapy, using DNA-microarray hybridization techniques [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment:	92
Study Start Date:	July 2003
Estimated Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm I (neoadjuvant therapy) see intervention description	Drug: carboplatin Cycle 1-8 Day 1 or 2 AUC = 6 IV Drug: docetaxel Cycle 1-8 Day 1 or 2: 75 mg/m2 IV Other Name: Taxotere Biological: trastuzumab Cycle 1-4 pre-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV Cycle 5-7 post-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV Other Name: Herceptin
Experimental: Arm II (neoadjuvant therapy) please see intervention description	Biological: trastuzumab Cycle 5-7 post-op only Day 1 4mg/kg IV Day 8, 15 2mg/kg IV Cycle 8 Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV Other Name: Herceptin Drug: carboplatin Cycle 1-8 Day 1 or 2 AUC = 6 IV Drug: docetaxel Cycle 1-8 Day 1 or 2: 75 mg/m2 IV Other Name: Taxotere
Experimental: HER2/neu negative patients please see intervention description	Drug: carboplatin Cycle 1-8 Day 1 or 2 AUC = 6 IV Drug: docetaxel Cycle 1-8 Day 1 or 2: 75 mg/m2 IV Other Name: Taxotere

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Confirmed infiltrating adenocarcinoma of the breast
Primary breast cancer > 5cm, or skin/chest wall involvement, any N, without evidence of metastasis.
No prior radiation to the involved breast
ECOG performance status 0-2
Age 18 years to 80 years
Absolute Neutrophil count > 1500 cell/μl, platelet count > 100000 cells/μl and hemoglobin > 9 g/dl
All liver function tests < upper limit of normal
Serum creatinine < 2.0 mg/dl
Normal left ventricular ejection fraction (LVEF) as determined by MUGA scan or echocardiogram
HER-2/neu status is determined by a FISH test. [FISH (+) is HER-2/neu (+)]
If female of childbearing potential, pregnancy test is negative
If premenopausal and not surgically sterilized, the patient agrees to use effective birth control method for the duration of the study
Informed consent has been obtained

Exclusion Criteria:

Non-confirmed infiltrating adenocarcinoma breast cancer
Evidence of metastasis
Previous chemotherapy using the drugs proposed in this study, specifically Herceptin®, Taxotere®, and/or Carboplatin
Prior radiation to the involved breast
Recent breast cancer drug therapy within last 5 years of any form
History of allergy to polysorbate or castor oil
Ongoing active infection
Concurrent life-limiting disease with a life expectancy of less than one year
Past or current history of other malignancy within the past 5 years which could affect the diagnosis or assessment of breast cancer, except for curatively treated non-melanoma skin cancer and/or in situ carcinoma of the cervix
Pregnancy, nursing, fertile women who do not use birth control device
Inability to give informed consent
Patients with pre-existing peripheral neuropathy > grade 2

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00068341

Locations

United States, Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089-9181
Wilshire Oncology Medical Group, Incorporated - Pomona
Pomona, California, United States, 91767-3021

Sponsors and Collaborators

University of California, Los Angeles

National Cancer Institute (NCI)

Aventis Pharmaceuticals

Genentech

Investigators

Principal Investigator:

Helena R. Chang, MD, PhD

Jonsson Comprehensive Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Helena R. Chang, Jonsson Comprehensive Cancer Center at UCLA
ClinicalTrials.gov Identifier:	NCT00068341 History of Changes
Other Study ID Numbers:	CDR0000321924, P30CA016042, UCLA-9911084, AVENTIS-GIA-11156, GENENTECH-H2269s
Study First Received:	September 10, 2003
Last Updated:	November 4, 2010
Health Authority:	United States: Federal Government; United States: Food and Drug Administration; United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:

stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage II breast cancer

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Docetaxel

Trastuzumab
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012