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

NCT ID: NCT00068341

Last Updated: 2020-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-07-31
• Study Completion Date: 2013-11-30

Brief Summary

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I (neoadjuvant therapy)

see intervention description

Group Type: EXPERIMENTAL

carboplatin

Intervention Type: DRUG

Cycle 1-8 Day 1 or 2 AUC = 6 IV

docetaxel

Intervention Type: DRUG

Cycle 1-8 Day 1 or 2: 75 mg/m2 IV

trastuzumab

Intervention Type: BIOLOGICAL

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

Arm II (neoadjuvant therapy)

please see intervention description

Group Type: EXPERIMENTAL

trastuzumab

Intervention Type: BIOLOGICAL

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

carboplatin

Intervention Type: DRUG

Cycle 1-8 Day 1 or 2 AUC = 6 IV

docetaxel

Intervention Type: DRUG

Cycle 1-8 Day 1 or 2: 75 mg/m2 IV

HER2/neu negative patients

please see intervention description

Group Type: EXPERIMENTAL

carboplatin

Intervention Type: DRUG

Cycle 1-8 Day 1 or 2 AUC = 6 IV

docetaxel

Intervention Type: DRUG

Cycle 1-8 Day 1 or 2: 75 mg/m2 IV

Interventions

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

Intervention Type: BIOLOGICAL

carboplatin

Cycle 1-8 Day 1 or 2 AUC = 6 IV

Intervention Type: DRUG

docetaxel

Cycle 1-8 Day 1 or 2: 75 mg/m2 IV

Intervention Type: DRUG

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

Intervention Type: BIOLOGICAL

Other Intervention Names

Herceptin; Taxotere; Herceptin

Eligibility 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 (Electrocochleography) 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 (Multiple Gated Acquisition) scan or echocardiogram
• HER-2/neu status is determined by a FISH (Fluorescence in situ hybridization) 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Aventis Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Jonsson Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Helena R. Chang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Jonsson Comprehensive Cancer Center

Locations

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, United States

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, United States

Wilshire Oncology Medical Group, Incorporated - Pomona

Pomona, California, United States

Countries

United States

Other Identifiers

CDR0000321924

Identifier Type: -

Identifier Source: secondary_id

AVENTIS-GIA-11156

Identifier Type: -

Identifier Source: secondary_id

GENENTECH-H2269s

Identifier Type: -

Identifier Source: secondary_id

99-11-084

Identifier Type: -

Identifier Source: org_study_id