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 @ 1:25 AM
Ignite Modification Date:
2025-12-25 @ 1:25 AM
NCT ID:
NCT00295893
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically proven infiltrating ductal or lobular breast carcinoma
* Stage II or III disease
* Inflammatory breast cancer allowed
* Hormone-receptor status not specified
PATIENT CHARACTERISTICS:
* ECOG performance status \< 2
* Male or female
* Menopausal status not specified (for female patients)
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Bilirubin normal (except for patient's with Gilbert's disease)
* Creatinine ≤ 1.2 mg/dL
* Creatinine clearance ≥ 70 mL/min
* Ejection fraction ≥ 50% on MUGA
* No neuropathy ≥ grade 1
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective nonhormonal contraception
* No prior malignant disease within the past 5 years, excluding:
* Squamous cell or basal cell skin carcinoma
* Stage I or in situ cervical carcinoma
* No noninvasive (in situ) breast carcinoma within the past 5 years
PRIOR CONCURRENT THERAPY:
* At least 5 years since prior antiestrogen treatment for any indication other than breast cancer prevention (tamoxifen, raloxifene, or an aromatase inhibitor)
* No prior radiotherapy to the chest wall
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00295893
Study Brief:
Protocol Section:
NCT00295893