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Status:

TERMINATED

Trastuzumab, Docetaxel, and Carboplatin in Treating Women With Stage II, Stage III, or Inflammatory Breast Cancer

Lead Sponsor:

University of Medicine and Dentistry of New Jersey

Collaborating Sponsors:

National Cancer Institute (NCI)

Aventis Pharmaceuticals

Conditions:

Breast Cancer

Eligibility:

FEMALE

18+ years

Phase:

PHASE2

Brief Summary

RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or...

Detailed Description

OBJECTIVES: Primary * Determine the antitumor activity of trastuzumab (Herceptin\^®), docetaxel, and carboplatin, as measured by tumor response rate, in women with previously untreated HER2/neu-posi...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed breast cancer, meeting 1 of the following stage criteria:
  • Stage IIB (T3, N0)
  • Stage IIIA (N0-N2)
  • Stage IIIB (T4, N0-2)
  • Stage IIIC
  • Inflammatory breast cancer
  • HER2/neu-positive disease by fluorescence in situ hybridization
  • Biopsy-accessible tumor
  • Measurable disease by physical examination or x-ray
  • No stage IV disease
  • Hormone receptor status:
  • Not specified
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 and over
  • Sex
  • Female
  • Menopausal status
  • Not specified
  • Performance status
  • ECOG 0-2
  • Life expectancy
  • At least 8 weeks
  • Hematopoietic
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Hepatic
  • Meets 1 of the following criteria:
  • SGOT and SGPT ≤ 5 times upper limit of normal (ULN) AND alkaline phosphatase normal
  • SGOT and SGPT ≤ 1.5 times ULN AND alkaline phosphatase ≤ 2.5 times ULN
  • SGOT and SGPT normal AND alkaline phosphatase ≤ 5 times ULN
  • Bilirubin normal
  • Renal
  • Creatinine normal
  • No pre-existing clinically significant renal disease that is not related to the malignancy
  • Cardiovascular
  • Ejection fraction ≥ 50% by MUGA
  • No pre-existing clinically significant cardiac disease that is not related to the malignancy
  • No history of congestive heart failure
  • Pulmonary
  • No pre-existing clinically significant pulmonary disease that is not related to the malignancy
  • Gastrointestinal
  • No severe malnutrition
  • No intractable emesis
  • Neurologic
  • No pre-existing clinically significant neurologic disease that is not related to the malignancy
  • No peripheral neuropathy ≥ grade 2
  • No nerve damage from diabetes
  • Other
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective non-hormonal contraception during and for 4 weeks after completion of study treatment
  • No known allergic reaction to study drugs
  • No active infection
  • No other malignancy except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • No other pre-existing clinically significant disease that is not related to the malignancy
  • No other serious or significant medical condition that would preclude study participation
  • No other contraindication to study treatment
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • No other concurrent immunotherapy
  • Chemotherapy
  • No prior chemotherapy for the malignancy
  • No other concurrent chemotherapy
  • Endocrine therapy
  • No concurrent hormonal therapy for the malignancy
  • Radiotherapy
  • No concurrent radiotherapy
  • Surgery
  • No concurrent surgery for the malignancy
  • Other
  • More than 2 weeks since prior and no concurrent herbal remedies or aspirin-containing products
  • No other concurrent investigational or commercial agents or therapies for the malignancy

Exclusion

    Key Trial Info

    Start Date :

    April 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    December 1 2008

    Estimated Enrollment :

    5 Patients enrolled

    Trial Details

    Trial ID

    NCT00118053

    Start Date

    April 1 2005

    End Date

    December 1 2008

    Last Update

    November 20 2013

    Active Locations (9)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 3 (9 locations)

    1

    Central Jersey Oncology Center, PA - East Brunswick

    East Brunswick, New Jersey, United States, 08816

    2

    CentraState Medical Center

    Freehold, New Jersey, United States, 07728

    3

    Cancer Institute of New Jersey at Hamilton

    Hamilton, New Jersey, United States, 08690

    4

    Mountainside Hospital Cancer Center

    Montclair, New Jersey, United States, 07042