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 @ 3:46 AM
Ignite Modification Date:
2025-12-25 @ 3:46 AM
NCT ID:
NCT00003902
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically proven adenocarcinoma of the breast
* Phase I: Measurable or evaluable disease
* Phase II: Bidimensionally measurable disease
* No CNS metastases
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age:
* 65 and over
Sex:
* Female
Menopausal status:
* Postmenopausal
Performance status:
* ECOG/SAKK 0-2
Life expectancy:
* At least 12 weeks
Hematopoietic:
* Normal peripheral blood counts
Hepatic:
* AST no greater than 2 times upper limit of normal (ULN) (no greater than 3 times ULN if liver metastases present)
Renal:
* Creatinine no greater than 1.5 times ULN
Other:
* No other prior or concurrent malignancy except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix
* No peripheral neuropathy grade 2 or higher
* No cognitive impairment or severe psychiatric disorder
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* More than 6 months since prior adjuvant chemotherapy
* No prior chemotherapy for metastatic or locally advanced disease
* No other concurrent chemotherapy
Endocrine therapy:
* Prior hormonal therapy for metastatic disease allowed
* No continuous concurrent steroids
* No concurrent systemic endocrine therapy for breast cancer
* No other concurrent endocrine therapy
Radiotherapy:
* No concurrent radiotherapy involving greater than 30% of bone marrow or mucosa
* Radiotherapy to nonindicator lesion allowed
Surgery:
* Not specified
Other:
* Bisphosphonates allowed if indicator lesion in nonbone site
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
65 Years
Study:
NCT00003902
Study Brief:
Protocol Section:
NCT00003902