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

This study has been completed.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Aventis Pharmaceuticals
Genentech, Inc.
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00068341
First received: September 10, 2003
Last updated: February 3, 2017
Last verified: March 2016
  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: No masking
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 ]

    Objective response rate of patients treated with Taxotere/carboplatin with or without Herceptin preoperatively. Objective response equals the combination of complete response (CR), partial response (PR) and marginal response (MR).

    Tumor size was assessed by (1) physical examination, (2) mammography and (3) MRI. 5 response groups: complete response (CR), partial response (PR), marginal response (MR), stable disease (SD) & disease progression (DP). Pathologic response assigned into 2 groups: pCR and non-pCR. pCR-no evidence of residual invasive disease in specimen.



Secondary Outcome Measures:
  • Clinical Tumor Response by Physical Exam and Imaging Studies [ Time Frame: 5 years ]
  • Tumor Response Assessment [ Time Frame: 5 years ]
    Measured by physical examination compared to breast mammography and MRI assessment

  • Clinico-histologic Predictors of pCR (Pathologic Complete Response) [ Time Frame: 5 years ]
  • Pathologic Nodal Status [ Time Frame: 5 years ]
    According to Primary Tumor Response Pathologic lymph node status N0 Axillary and other nearby lymph nodes do not have cancer (when looked at under a microscope) N1 Micrometastases (very small clusters of cancer) OR 1-3 axillary lymph nodes have cancer AND/OR Internal mammary nodes have tiny amounts of cancer found on sentinel node biopsy N2 4-9 axillary lymph nodes have cancer OR Internal mammary nodes have cancer, but axillary lymph nodes do not have cancer N3 10 or more axillary lymph nodes have cancer OR Infraclavicular (under the clavicle) nodes have cancer OR Internal mammary nodes have cancer plus 1 or more axillary lymph nodes have cancer OR 4 or more axillary lymph nodes have cancer plus internal mammary nodes have cancer or micrometastases found on sentinel node biopsy OR Supraclavicular (above the clavicle) nodes have cancer


Enrollment: 74
Study Start Date: July 2003
Study Completion Date: November 2013
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   (Adult, Senior)
Sexes 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 (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
  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
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089-9181
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
Wilshire Oncology Medical Group, Incorporated - Pomona
Pomona, California, United States, 91767-3021
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Aventis Pharmaceuticals
Genentech, Inc.
Investigators
Principal Investigator: Helena R. Chang, MD, PhD Jonsson Comprehensive Cancer Center
  More Information

Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00068341     History of Changes
Other Study ID Numbers: CDR0000321924
P30CA016042 ( US NIH Grant/Contract Award Number )
UCLA-9911084
AVENTIS-GIA-11156
GENENTECH-H2269s
Study First Received: September 10, 2003
Results First Received: February 11, 2016
Last Updated: February 3, 2017

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
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 25, 2017