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Completed

NCT Number: NCT00068341

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

trastuzumab

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

Other names: Herceptin

carboplatin

Drug

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

docetaxel

Drug

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

Other names: Taxotere

Primary outcomes

  1. 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 outcomes

  1. Clinical Tumor Response by Physical Exam and Imaging Studies

    Time frame: 5 years

  2. Tumor Response Assessment

    Time frame: 5 years

    Measured by physical examination compared to breast mammography and MRI assessment

  3. Clinico-histologic Predictors of pCR (Pathologic Complete Response)

    Time frame: 5 years

  4. 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

Sponsors and collaborators

Lead sponsor

Jonsson Comprehensive Cancer Center

Other

Collaborators

  • Aventis Pharmaceuticals
  • Genentech, Inc.

Registry information

Official study title

Neoadjuvant Treatment and Molecular Characterization of Locally Advanced Breast Cancer

Important dates

Study start
2003
Primary completion
2013
Study completion
2013
First posted
Sep 11, 2003
Registry last updated
Sep 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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