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 @ 1:13 AM
Ignite Modification Date:
2025-12-25 @ 1:13 AM
NCT ID:
NCT00003893
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed invasive breast cancer
* Early-stage disease
* No metastatic disease
* Complete surgical excision of tumor
* Planned use of adjuvant chemotherapy and radiotherapy
* If participating in the cosmetic outcome evaluation portion of the study, must have unilateral disease
* Hormone receptor status
* Not specified
PATIENT CHARACTERISTICS:
Age:
* Not specified
Sex:
* Female
Menopausal status:
* Not specified
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* Bone marrow function adequate
Hepatic:
* Hepatic function adequate
Renal:
* Renal function adequate
Cardiovascular:
* Cardiac function adequate
Other:
* No other prior malignancy except basal cell or squamous cell skin cancer or carcinoma in situ
* No other medical or social condition that would preclude study compliance
* Fit to receive both adjuvant chemotherapy and radiotherapy (administered either synchronously or sequentially)
* Not pregnant or nursing
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* See Disease Characteristics
* No prior chemotherapy
* No concurrent epirubicin and doxorubicin as a study combination chemotherapy regimen
Endocrine therapy:
* Prior or concurrent hormonal therapy allowed
* No concurrent tamoxifen if treated with methotrexate, mitomycin, and mitoxantrone as a study combination chemotherapy regimen
Radiotherapy:
* See Disease Characteristics
* No concurrent internal mammary chain irradiation
* No concurrent orthovoltage irradiation to the whole breast
Surgery:
* See Disease Characteristics
* Recovered from prior surgery
Other:
* Concurrent participation in another clinical trial allowed
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT00003893
Study Brief:
Protocol Section:
NCT00003893