Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2025-12-25 @ 2:52 AM
NCT ID:
NCT00321633
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT00321633
Study Brief:
Protocol Section:
NCT00321633