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

This study has been completed.
Sponsor:
Collaborators:
Aventis Pharmaceuticals
Genentech
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00068341
First received: September 10, 2003
Last updated: June 6, 2014
Last verified: June 2014
  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 2

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:


Further study details as provided by Jonsson Comprehensive Cancer Center:

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: 80
Study Start Date: July 2003
Primary Completion Date: November 2013 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Jonsson Comprehensive Cancer Center
Aventis Pharmaceuticals
Genentech
Investigators
Principal Investigator: Helena R. Chang, MD, PhD Jonsson Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Jonsson Comprehensive Cancer Center
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: June 6, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Jonsson Comprehensive Cancer Center:
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
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 27, 2014