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 @ 9:21 PM
Ignite Modification Date:
2025-12-24 @ 9:21 PM
NCT ID:
NCT00028704
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed locally advanced breast cancer
* T3 inoperable, N0-N2
* Any T, N2
* T4, N0-N2
* Inflammatory breast carcinoma
* Prior treatment with 4-6 courses of standard induction chemotherapy or active investigational regimens completed within the past 4 weeks
* Residual tumor size less than 5 cm
* No fixed axillary lymph nodes
* No multifocal or bilateral breast cancer
* No clinical suspicion of extensive ductal carcinoma in situ
* No unresolved skin edema
* No distant metastases (including ipsilateral supraclavicular node)
* Positive bone scan allowed provided there are no bone metastases on x-ray
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age:
* Any age
Sex:
* Female
Menopausal status:
* Not specified
Performance status:
* WHO 0-1
Life expectancy:
* Not specified
Hematopoietic:
* Neutrophil count at least 2,000/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin less than 1.5 times normal
* SGOT and SGPT no greater than 2 times normal
* Alkaline phosphatase no greater than 2 times normal
Renal:
* Creatinine less than 1.5 times normal
Other:
* No other prior or concurrent malignancy except adequately treated squamous cell or basal cell skin cancer or adequately treated cone-biopsied carcinoma in situ of the cervix
* No serious underlying medical illness that would preclude study
* No psychiatric or addictive disorder that would preclude study
* No contraindication to study treatment
* Not pregnant
* Fertile patients must use effective barrier contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* See Disease Characteristics
Endocrine therapy:
* No concurrent hormonal replacement therapy
* No concurrent oral contraceptives
Radiotherapy:
* See Disease Characteristics
* No prior radiotherapy for breast cancer
Surgery:
* No prior surgery for breast cancer other than biopsy for diagnosis confirmation
Other:
* No other prior systemic therapy for breast cancer
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT00028704
Study Brief:
Protocol Section:
NCT00028704