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 @ 3:01 AM
Ignite Modification Date:
2025-12-25 @ 3:01 AM
NCT ID:
NCT00771433
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of breast cancer
* Receiving 1 of the following neoadjuvant or adjuvant chemotherapy regimens:
* Six courses of epirubicin hydrochloride and docetaxel
* Six courses of fluorouracil, epirubicin hydrochloride, and cyclophosphamide (FEC) 100 or 3 courses of FEC 100 and 3 courses of docetaxel 100
* Must have received at least 2 chemotherapy regimens prior to study therapy
* No malignant hematological disease
* Hormone receptor status not specified
PATIENT CHARACTERISTICS:
* Menopausal status not specified
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No contraindications to standard neoadjuvant or adjuvant chemotherapy
* No known hypersensitivity to G-CSF or any of its components
* No patients deprived of liberty or under guardianship
* No psychological, familial, social, or geographical reasons preventing follow-up
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No concurrent participation in another experimental drug study
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00771433
Study Brief:
Protocol Section:
NCT00771433