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 @ 11:32 PM
Ignite Modification Date:
2025-12-24 @ 11:32 PM
NCT ID:
NCT00006256
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Stage II or III invasive breast cancer
* Prior breast conserving surgery (lumpectomy or quadrantectomy) with ipsilateral axillary lymph node dissection required
* No prior contralateral breast cancer
* No metastatic disease
* Prior ductal carcinoma in situ or lobular carcinoma in situ of the breast allowed unless treated with radiation or chemotherapy
* Doxorubicin and cyclophosphamide adjuvant chemotherapy completed within past 3 weeks
* Candidate for definitive radiotherapy
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Sex:
* Female
Menopausal status:
* Not specified
Performance status:
* ECOG 0-1
Life expectancy:
* Not specified
Hematopoietic:
* WBC at least 3,000/mm3
* Granulocyte count at least 2,000/mm3
* Platelet count at least 100,000/mm3
Hepatic:
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* ALT/AST no greater than 1.5 times ULN
Renal:
* Creatinine no greater than 1.5 mg/dL
Cardiovascular:
* No concurrent poorly controlled ischemic heart disease or congestive heart failure
* LVEF at least 45% by MUGA scan or echocardiogram
Pulmonary:
* No concurrent severe chronic obstructive or restrictive pulmonary disease
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No concurrent severe medical or psychiatric illness
* No concurrent severe diabetes mellitus
* No other prior malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix treated with local excision
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No concurrent filgrastim (G-CSF)
Chemotherapy:
* See Disease Characteristics
* Prior tamoxifen allowed
* No concurrent tamoxifen
Endocrine therapy:
* Not specified
Radiotherapy:
* No prior radiation to the breast
Surgery:
* Recovered form prior surgery
Other:
* No concurrent adjuvant therapy on another clinical trial
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00006256
Study Brief:
Protocol Section:
NCT00006256