This trial is active, not recruiting.

Condition breast cancer
Treatments letrozole, conventional surgery
Phase phase 2
Sponsor Washington University School of Medicine
Collaborator National Cancer Institute (NCI)
Start date October 2003
End date March 2007
Trial size 115 participants
Trial identifier NCT00084396, CDR0000361963, P30CA091842, R01CA095614, UCSF-02755, UCSF-H8409-21398-04, WU-03-0586


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 shrink the tumor so that it can be removed.

PURPOSE: This phase II trial is studying how well neoadjuvant letrozole works in treating postmenopausal women who are undergoing surgery for estrogen-receptor positive or progesterone-receptor positive stage II, stage IIIA, or stage IIIB breast cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Masking open label
Primary purpose treatment
conventional surgery

Primary Outcomes

Predictive model for response as assessed by gene expression profiling
time frame:

Secondary Outcomes

Response rate
time frame:
Changes in Ki67 proliferation rates
time frame:
Rate of improvement in surgical outcomes
time frame:
Long-term outcomes
time frame:
time frame:
Mechanisms of resistance
time frame:

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title A Phase 2 Trial Of 4 Months Preoperative Letrozole 2.5 mg Daily For Postmenopausal Women With Estrogen Receptor Positive And/Or Progesterone Receptor Positive T2, T3, T4a-c, N0-2, M0 Breast Cancer- Novel Biomarkers for Aromatase Inhibitor Therapy
Principal investigator Michael Naughton, M.D.
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 breast cancer treated with neoadjuvant letrozole. Secondary - Determine the response rate in patients treated with this drug. - Determine changes in Ki67 proliferation rates in patients treated with this drug. - Determine the rate of improvement in surgical outcomes in patients treated with this drug. - Determine the long-term outcomes in patients treated with this drug. - Determine the safety of this drug in these patients. - Determine mechanisms of resistance to this drug in these patients. OUTLINE: This is a multicenter study. Patients receive neoadjuvant oral letrozole once daily for 16 weeks in the absence of disease progression. Patients then undergo breast surgery one day after the last dose of letrozole. Patients with partial response after 16 weeks may continue to receive letrozole for an additional 8 weeks before undergoing breast surgery. Patients are followed within 4 weeks after definitive surgery and then annually for 10 years. PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Washington University School of Medicine.