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 @ 7:45 PM
Ignite Modification Date:
2025-12-24 @ 7:45 PM
NCT ID:
NCT00008203
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed breast cancer
* Stage II with at least 10 lymph nodes involved with malignancy OR
* Stage III (any T3b-T4, N2 or N3, M0)
* Ineligible for other high priority national or institutional study
* No metastasis to brain (confirmed by CT or MRI)
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age:
* 18 to physiologic 65
Sex:
* Female
Menopausal status:
* Not specified
Performance status:
* ECOG 0-1
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Bilirubin less than 2 times normal
Renal:
* Creatinine less than 1.5 times normal
Cardiovascular:
* LVEF at least 45%
Other:
* HIV negative
* Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* At least 3 cycles of prior chemotherapy required
* Stage II patients must have completed 4-6 courses of doxorubicin and/or taxol-based adjuvant chemotherapy
* Stage III patients must have achieved complete or partial response to 4-6 courses of doxorubicin and/or taxol-based induction chemotherapy
* No other concurrent chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* Not specified
Surgery:
* Not specified
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00008203
Study Brief:
Protocol Section:
NCT00008203