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Status:

COMPLETED

Carboplatin or Docetaxel in Treating Women With Metastatic Genetic Breast Cancer

Lead Sponsor:

University College London Hospitals

Conditions:

brca1 Mutation Carrier

brca2 Mutation Carrier

Eligibility:

FEMALE

Phase:

PHASE2

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as carboplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is...

Detailed Description

OBJECTIVES: Primary * Compare the safety and effectiveness of carboplatin vs docetaxel in women with metastatic breast cancer and the BRCA1 or BRCA2 gene mutation. Secondary * Compare time to dise...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed breast cancer
  • BRCA1 or BRCA2 mutation carrier
  • Metastatic disease
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
  • Stable, treated brain metastases allowed provided other sites of measurable disease are present
  • Patients with bone metastases who are currently receiving bisphosphonates for palliation are eligible provided other sites of measurable disease are present
  • Patients who have not received anthracycline-based chemotherapy in the adjuvant setting may receive a non-taxane, anthracycline regimen as the first-line metastatic treatment and enter the trial at confirmed progression (second-line)
  • No bone-limited disease
  • No disease suitable for endocrine therapy alone
  • Hormone receptor status not specified
  • PATIENT CHARACTERISTICS:
  • Menopausal status not specified
  • Sex: female
  • WHO performance status 0-2
  • Life expectancy ≥ 3 months
  • AST and/or ALT ≤ 5 times upper limit of normal (ULN) (≤ 3 if alkaline phosphatase \> 5 times ULN)
  • Glomerular filtration rate ≥ 30 mL/min
  • Normal urea and creatinine
  • Normal hematological and biochemical studies
  • Normal bilirubin
  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for 6 months after completion of study treatment
  • Negative pregnancy test
  • No known allergy to platinum compounds or mannitol
  • No known sensitivity to taxanes
  • No other malignancy within the past 10 years except adequately treated in situ carcinoma of the cervix or basal cell or squamous cell carcinoma of the skin
  • No sensory or motor neuropathy \> grade 1
  • No other serious uncontrolled medical conditions or concurrent medical illness that would preclude study compliance
  • No contraindication to chemotherapy
  • PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics
  • At least 12 months since prior taxane therapy
  • No prior chemotherapy with a platinum drug, unless treatment was for a non-breast cancer-related disease more than 10 years ago

Exclusion

    Key Trial Info

    Start Date :

    September 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    Estimated Enrollment :

    148 Patients enrolled

    Trial Details

    Trial ID

    NCT00321633

    Start Date

    September 1 2005

    Last Update

    August 26 2013

    Active Locations (25)

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

    Page 1 of 7 (25 locations)

    1

    Royal Melbourne Hospital

    Parkville, Victoria, Australia, 3050

    2

    Soroka University Medical Center

    Beersheba, Israel, 84101

    3

    Naharia Hospital

    Nahariya, Israel

    4

    Chaim Sheba Medical Center

    Tel Litwinsky, Israel, 52621