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:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-24 @ 2:55 PM
NCT ID:
NCT00217659
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed breast cancer
* Recurrent or metastatic (stage IV) disease
* Patients with a local regional recurrence, including axillary and/or chest wall involvement, are eligible
* Measurable or non-measurable disease
* Brain metastases allowed provided they have been treated with surgery or radiotherapy AND have remained stable for ≥ 3 months
* Hormone receptor status:
* Estrogen receptor- OR progesterone receptor- positive disease by standard immunohistochemical techniques
PATIENT CHARACTERISTICS:
Age
* 18 and over
Sex
* Male
Performance status
* Zubrod 0-2
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* No evidence of severe or uncontrolled hepatic disease
Renal
* No evidence of severe or uncontrolled renal disease
Cardiovascular
* No evidence of severe or uncontrolled cardiac disease
Pulmonary
* No evidence of severe or uncontrolled respiratory disease
Other
* Fertile patients must use effective barrier-method contraception during and for 12 weeks after the completion of study treatment
* No known HIV positivity
* Able to receive oral medication
* Patients with a gastrointestinal tube are eligible
* No known hypersensitivity to luteinizing hormone-releasing hormone (LHRH), LHRH agonist analogues, or any components of the study drugs
* No active infection requiring systemic therapy
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer
* No evidence of other severe or uncontrolled systemic disease
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No concurrent prophylactic filgrastim (G-CSF) or other hematopoietic growth factors
Chemotherapy
* At least 14 days since prior chemotherapy for this cancer and recovered
* No more than 1 prior chemotherapy regimen for metastatic disease
* No concurrent chemotherapy
Endocrine therapy
* At least 14 days since prior hormonal therapy for this cancer and recovered
* Prior tamoxifen allowed
* No prior gonadotropin-releasing hormone antagonist, aromatase inhibitors, or fulvestrant
* No other concurrent hormonal therapy (e.g., estrogen-based therapies)
Radiotherapy
* See Disease Characteristics
* At least 14 days since prior radiotherapy for this cancer and recovered
* No concurrent radiotherapy
Surgery
* See Disease Characteristics
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00217659
Study Brief:
Protocol Section:
NCT00217659