Status:
COMPLETED
Neoadjuvant Letrozole in Treating Postmenopausal Women With Estrogen-Receptor Positive and/or Progesterone-Receptor Positive Stage II, Stage IIIA, or Stage IIIB Breast Cancer
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by reducing the production of estrogen. Giving letrozole before surgery may...
Detailed Description
OBJECTIVES: Primary * Develop a predictive model of response (based on gene expression profiling) in postmenopausal women with estrogen- and/or progesterone-receptor positive stage II, IIIA, or IIIB...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed infiltrating adenocarcinoma of the breast by core needle biopsy
- Clinical stage T2-T4a-c, N0-2, M0
- Palpable and measurable disease
- Previously untreated disease
- Benefits from neoadjuvant therapy that would improve surgical outcome AND meets criteria for 1 of the following:
- Marginal candidate for lumpectomy (e.g., lumpectomy feasible but patient at risk for positive margins or poor cosmetic outcome) AND patient desires breast-conserving surgery
- Ineligible for lumpectomy due to size of primary tumor, but modified radical mastectomy feasible AND patient desires breast-conserving surgery
- Inoperable disease AND systemic therapy required for disease to become operable by modified radical mastectomy
- Bilateral primary tumors allowed provided both tumors are consistent with entry criteria
- No inflammatory carcinoma (defined as peau d' orange affecting at least one third of the breast)
- Direct extension of the tumor to the skin allowed
- No metastatic breast disease, except isolated ipsilateral supraclavicular lymphadenopathy
- Hormone receptor status:
- Estrogen- and/or progesterone-receptor positive disease based on 10% or more nuclear staining of the invasive component of the tumor
- PATIENT CHARACTERISTICS:
- Age
- Postmenopausal
- Sex
- Female
- Menopausal status
- Postmenopausal, defined as meeting 1 of the following criteria:
- Cessation of menstrual periods for at least 1 year
- Bilateral surgical oophorectomy
- Follicle-stimulating hormone and estradiol levels in the postmenopausal range
- Performance status
- ECOG 0-2
- Life expectancy
- Not specified
- Hematopoietic
- Not specified
- Hepatic
- No severe liver dysfunction that would preclude study participation
- Renal
- Not specified
- Other
- Willing and able to provide biopsy material
- Willing to undergo breast surgery after neoadjuvant treatment
- No condition (e.g., confusion, infirmity, or alcoholism) that would preclude study compliance
- No other concurrent active and progressive invasive malignancies
- No other concurrent severe disease that would preclude study participation
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- No concurrent immunotherapy or biological response modifiers for breast cancer
- Chemotherapy
- No prior chemotherapy for breast cancer
- No concurrent chemotherapy for breast cancer
- Endocrine therapy
- At least 2 weeks since prior hormone replacement therapy or phytoestrogenic herbal, alternative, or over-the-counter (OTC) sex hormone remedies
- No prior hormonal agents for breast cancer
- No prior aromatase inhibitors, tamoxifen, raloxifene, or other antiestrogen or selective estrogen receptor modulators
- No concurrent drugs known to affect sex hormone status, including hormone replacement therapy or phytoestrogenic herbal, alternative, or OTC remedies
- No other concurrent endocrine therapy for breast cancer
- Radiotherapy
- No prior radiotherapy for breast cancer
- No concurrent radiotherapy for breast cancer
- Surgery
- Prior sentinel node biopsy allowed
- No other concurrent surgery for breast cancer
- Other
- More than 30 days since prior non-approved or experimental drugs
- Concurrent bisphosphonates for osteoporosis allowed
- No other concurrent treatment for breast cancer
Exclusion
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT00084396
Start Date
October 1 2003
End Date
September 1 2016
Last Update
September 26 2016
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110