Clinical trial NCT00068341: Docetaxel and Carboplatin With or Without Trastuzumab Before Surgery in Treating Women With Locally Advanced Breast Cancer
Official title: Neoadjuvant Treatment and Molecular Characterization of Locally Advanced Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage II breast cancer
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: Aventis Pharmaceuticals
name: Genentech, Inc.
First posted: 2003-09-11
Enrollment: 74
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Evaluate the Objective Response Rate of Patients Treated With Taxotere/Carboplatin With or Without Herceptin Preoperatively.
timeFrame: 5 years
Secondary outcomes:
measure: Clinical Tumor Response by Physical Exam and Imaging Studies
timeFrame: 5 years
measure: Tumor Response Assessment
timeFrame: 5 years
measure: Clinico-histologic Predictors of pCR (Pathologic Complete Response)
timeFrame: 5 years
measure: Pathologic Nodal Status
timeFrame: 5 years
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
state: Arkansas
city: Los Angeles
country: United States
facility: USC/Norris Comprehensive Cancer Center and Hospital
state: California
city: Los Angeles
country: United States
facility: Jonsson Comprehensive Cancer Center at UCLA
state: California
city: Pomona
country: United States
facility: Wilshire Oncology Medical Group, Incorporated - Pomona
state: California
Study officials:
affiliation: Jonsson Comprehensive Cancer Center
name: Helena R. Chang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: