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 @ 5:31 PM
Ignite Modification Date:
2025-12-24 @ 5:31 PM
NCT ID:
NCT00902668
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of invasive or in situ epithelial cancer of the breast
* Stage 0, I, or II (Tis, T1, or T2) disease
* Unifocal disease (single focus that can be encompassed by breast-conserving surgery)
* Has undergone prior surgical resection of the primary lesion (lumpectomy) and axillary nodal evaluation (if invasive disease is present)
* Negative surgical margins (≥ 1 mm)
* Planning to undergo radiotherapy with either standard external beam radiotherapy or accelerated partial breast irradiation (interstitial or balloon brachytherapy)
* No Paget disease of the nipple
* No evidence of distant metastases
* Hormone receptor status not specified
PATIENT CHARACTERISTICS:
* Menopausal status not specified
* Karnofsky performance status 70-100%
* Transaminases \< 3 times upper limit of normal (ULN)
* Creatine kinase \< 5 times ULN
* Creatinine clearance ≥ 30 mL/min
* Negative pregnancy test
* No active liver or muscle disease
* No history of collagen vascular disease (e.g., systemic lupus erythematosus, scleroderma, or dermatomyositis)
* History of prior malignancy allowed provided life expectancy is ≥ 4 years
* No major medical or psychiatric illness that, in the investigator's opinion, would prevent completion of study treatment or interfere with follow-up
* No contraindication to an HMG-coA-reductase inhibitor
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior radiotherapy to the breast, lung, or mediastinum
* Prior radiotherapy to the contralateral breast allowed
* No chemotherapy for ≥ 2 weeks prior to, during, and for ≥ 2 weeks after completion of radiotherapy
* No concurrent cytochrome P450 3A4 inhibitors
* Concurrent HMG-coA-reductase inhibitor allowed provided patient is able to switch to 20 mg of lovastatin per day
* Concurrent tamoxifen or an aromatase inhibitor allowed
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00902668
Study Brief:
Protocol Section:
NCT00902668