drugset / Trial / NCT07394946

Neoadjuvant Letrozole in Postmenopausal Women With Hormone Receptor-Positive, HER2-Negative, Node Positive, Early-Stage Breast Cancer.

NCT07394946

Phase 2 Not yet recruiting 126 enrolled Cancer Care Hospital & Research Centre Foundation, Lahore
NaSingle-groupOpen-labelTreatment

Summary

The goal of this clinical trial is to learn whether letrozole, a hormone therapy drug, is effective in treating early-stage, hormone receptor-positive, HER2-negative breast cancer that has spread to nearby lymph nodes in postmenopausal women. The study will also evaluate the safety of taking letrozole for one year before surgery. The main questions this study aims to answer are: Can one year of letrozole eliminate cancer from the underarm (axillary) lymph nodes? Can treatment with letrozole reduce the need for extensive lymph node surgery? How safe and tolerable is long-term letrozole treatment? This is a single-arm study, meaning all participants will receive letrozole. There is no placebo or comparison group. Participants will: Take letrozole 2.5 mg by mouth once daily for one year Attend regular clinic visits for physical exams, blood tests, and imaging studies Undergo surgery after completing treatment Be followed for up to two years to monitor cancer recurrence and survival

Timeline

Start
2026-06
Primary completion
2027-07
Completion
2029-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Letrozole Other / unclassified 2.5 mg Oral