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

Jonsson Comprehensive Cancer Center

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: docetaxel; Biological: trastuzumab; Drug: carboplatin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00068341

GENENTECH-H2269s

99-11-084

CDR0000321924

AVENTIS-GIA-11156

Details and patient eligibility

About

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.

Enrollment: 74 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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74 participants in 3 patient groups

Arm I (neoadjuvant therapy)

Experimental group

Description:

see intervention description

Treatment:

Drug: carboplatin

Biological: trastuzumab

Drug: docetaxel

Biological: trastuzumab

Arm II (neoadjuvant therapy)

Experimental group

Description:

please see intervention description

Treatment:

Drug: carboplatin

Biological: trastuzumab

Drug: docetaxel

Biological: trastuzumab

HER2/neu negative patients

Experimental group

Description:

please see intervention description

Treatment:

Drug: carboplatin

Drug: docetaxel