If you're a postmenopausal woman just diagnosed with a common, hormone-sensitive type of breast cancer, your treatment plan might soon include a short, powerful step before surgery. This study looked at giving the drug letrozole for just 1 to 4 weeks before the scheduled operation to remove the tumor. The goal was to see if this brief pre-surgical treatment could slow down the cancer's growth in a meaningful way. Doctors took a small sample of the tumor with a needle biopsy at diagnosis. Then, after the patient took letrozole daily, they took another sample on the day of surgery to compare. The main thing they measured was a protein in the cancer cells called Ki67, which acts like a gauge of how fast the cells are dividing. By comparing the Ki67 levels before and after the letrozole course, researchers could see how much the drug affected the cancer's activity in a short time. This isn't meant to replace standard surgery or long-term therapy, but it gives doctors a real-time snapshot of how a patient's specific cancer responds to hormone-blocking treatment. Understanding this initial response could help inform decisions about further treatment after surgery.
Can a short course of letrozole before surgery help shrink hormone-sensitive breast cancer?
Plain Language Summary
What this means for you:
A brief course of letrozole before surgery may quickly reduce cancer cell growth in hormone-sensitive breast tumors. What this means for you:
A brief course of letrozole before surgery may quickly reduce cancer cell growth in hormone-sensitive breast tumors. View Original Abstract ↓
Status: COMPLETED | Phase: PHASE2
Condition(s): Breast Cancer Female
Intervention(s): Letrozole (DRUG)
A short pre-surgical non-therapeutic trial involving postmenopausal women with newly diagnosed eR+, HeR2-negative operable breast cancers. After undergoing a core needle biopsy for tissue acquisition, study participants will take a 7- to 30-day (1-4 weeks) course of letrozole in accordance with standard of care. They will then undergo definitive surgical resection of their primary tumor (mastectomy vs lumpectomy) as per standard of care guidelines.
Detailed: Patients will receive a prescription for letrozole to be taken orally at a dose of 2.5 mg/day for 7-30 days to allow for variations in surgical scheduling. Patients are to undergo surgical resection of their tumor the day after the last dose of letrozole.
Post-treatment tumor biopsies (a goal of 4-6 cores) will be obtained following 7-30 days of letrozole treatment on the day of surgery. Frozen AND formalin fixed core biopsies will be obtained whenever possible. The tissue will be used for study-specific assays as well as routine histopathology. Post-treatment core needle biopsy tissue will be obtained, whenever possible, by the surgeon intraoperatively at the time of routine surgical resection. A formalin-fixed paraffin embedded tumor block from the patient's surgical resection is also r
Primary Outcome(s): Measure Ki67 Index in Highly Hormone-dependent Breast Cancers vs. Those That Are Not
Enrollment: 61 (ACTUAL)
Lead Sponsor: University of Texas Southwestern Medical Center
Start: 2018-11-27 | Primary Completion: 2025-02-24
Results posted: 2026-03-16