Letrozole in Treating Postmenopausal Women With Ductal Carcinoma in Situ

Status: Recruiting
Diagnosis: Breast: Early Stage Disease
NCT ID: NCT01439711 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-309


RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by blocking the use of estrogen by the tumor cells or by lowering the amount of estrogen the body makes. PURPOSE: This phase II trial is studying how well letrozole works in treating women with ductal carcinoma in situ.


Conducting Institutions:
Brigham and Women's Hospital, Dana-Farber Cancer Institute

Overall PI:
Mehra Golshan, MD, Brigham and Women's Hospital

Site-responsible Investigators:

Dana-Farber Cancer Institute: Breast Cancer Nursing Team, 617-632-3478

Eligibility Criteria

DISEASE CHARACTERISTICS: - Pathologic confirmation of ductal carcinoma in situ (DCIS) without invasive cancer of the female breast with diagnosis rendered on core biopsy only, completed within 60 days before registration - Patients diagnosed with DCIS on the basis of surgical biopsy are not eligible for this study - Disease stage Tis, N0, M0 - All patients must have had a diagnostic core biopsy with clip placed at time of biopsy or prior to baseline MRI - Diagnostic tissue available for correlative studies - DCIS must express estrogen receptor, as determined by immunohistochemical methods on the diagnostic pathology sample, according to the local institution's standard protocol - Greater than or equal to 1% cells will be considered to be positive - Measurable disease - Mammographic extent of calcifications must be accurately measurable in at least one dimension with each lesion ≥ 1 cm and ≤ 5 cm - DCIS must be visible on MRI without radiographic evidence of invasive cancer - Patients with palpable DCIS or adenopathy are not eligible to participate PATIENT CHARACTERISTICS: - Patients must be postmenopausal* defined as: - Age ≥ 55 years and one year or more of amenorrhea - Age < 55 years and one year or more of amenorrhea, with an estradiol assay < 20 pg/mL - Surgical menopause with bilateral oophorectomy (at least 28 days must elapse from surgery to time of study registration) NOTE: *The use of GnRH analogs to achieve postmenopausal status is not allowed. - ECOG performance status 0 or 1 - ANC ≥ 1,000/μL - Platelet count ≥ 100,000/μL - Serum creatinine ≤ 1.7 mg/dL - Bilirubin ≤ 2.0 mg/dL - AST/ALT ≤ 2.5 times upper limit of normal - Serum estradiol level assay < 20 pg/mL - Required for patients < 55 years of age and one year or more of amenorrhea - Not pregnant or nursing - No contraindications to breast MRI - Women diagnosed with osteoporosis may participate in this trial provided they are receiving appropriate therapy PRIOR CONCURRENT THERAPY: - No prior surgical excision in the index breast for ductal carcinoma in situ (DCIS) or invasive cancer - Any exogenous hormone therapy must be completed 4 weeks prior to registration - Any patients with a history of tamoxifen or raloxifene use will be excluded - No prior neoadjuvant/adjuvant therapy for breast cancer
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