Phase II Study of Neoadjuvant Letrozole for Postmenopausal Women With Estrogen Receptor Positive Ductal Carcinoma In SITU (DCIS)
- To estimate the mean change in MRI tumor volume from pretreatment to completion of
preoperative endocrine therapy in estrogen receptor-positive (ER+) ductal carcinoma in
situ (DCIS), as well as to determine whether 3-month change in volume correlates with
- To assess radiographic-pathologic correlation between MRI findings and histopathology,
including the prevalence of occult invasive cancer in patients undergoing neoadjuvant
endocrine therapy for DCIS.
- To compare changes in MRI maximum lesion diameter and mammographic extent at baseline
and following treatment.
- To determine practice patterns of adjuvant hormonal and radiation therapy in patients
who complete neoadjuvant letrozole therapy for DCIS.
- To determine whether Ki67 is reduced with neoadjuvant letrozole treatment for DCIS, and
to compare the reduction in proliferation between radiographic responders and
- To identify baseline IHC and expression biomarkers predictive of response to treatment,
with response determined by extent of Ki67 reduction.
- To examine whether germline polymorphisms are associated with clinical endpoints,
including treatment-related toxicity or efficacy outcomes, or with expression of
biomarkers in serum or tumor.
- To assess quality-of-life and musculoskeletal symptoms associated with neoadjuvant
letrozole for ER+ DCIS.
OUTLINE: This is a multicenter study.
Patients receive neoadjuvant letrozole orally (PO) once daily (QD) for 3 months. Patients
then undergo MRI with an IV contrast. Patients with progressive disease discontinue
letrozole and undergo surgery. Patients with complete, partial, or stable disease continue
letrozole PO QD for an additional 3 months before undergoing another MRI and surgery.
Patients continue receiving letrozole until the day before surgery.
Surgery (mastectomy or lumpectomy) must be performed within 30 days of the 3- or 6-month
Patients' core biopsy specimen and surgical excision specimen may be collected for
Patients may complete the Menopause Specific Quality-of-Life Questionnaire (MEMOQOL), the
Brief Pain Inventory (BPI-SF), the Functional Assessment of Cancer Therapy - General
(FACT-G), the Self-Efficacy for Coping with Side Effects, the Medication Taking Behavior
(MMAS), and the Beliefs about Medicines Questionnaires at baseline and periodically during
After completion of study therapy, patients are followed up at 1, 3, and 6 months.
Masking: Open Label, Primary Purpose: Treatment
3-month and 6-month radiographic tumor volume
E. Shelley Hwang, MD, MPH
|Mayo Clinic Scottsdale||Scottsdale, Arizona 85259|
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|CCOP - Bay Area Tumor Institute||Oakland, California 94609-3305|
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill||Chapel Hill, North Carolina 27599-7570|
|St. Elizabeth Medical Center||Edgewood, Kentucky 41017|
|UCSF Helen Diller Family Comprehensive Cancer Center||San Francisco, California 94115|
|M. D. Anderson Cancer Center at University of Texas||Houston, Texas 77030-4009|
|Missouri Baptist Cancer Center||St. Louis, Missouri 63131|
|Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center||Columbus, Ohio 43210-1240|
|Pardee Memorial Hospital||Hendersonville, North Carolina 28791|
|Bethesda North Hospital||Cincinnati, Ohio 45242|
|Duke Cancer Institute||Durham, North Carolina 27710|