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NOT YET RECRUITING
NCT07394946
PHASE2

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

Sponsor: Cancer Care Hospital & Research Centre Foundation, Lahore

View on ClinicalTrials.gov

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

Official title: Neo-Adjuvant Endocrine Therapy in Post-Menopausal Hormone Receptor Positive HER 2 Neu Negative Node Positive Early-Stage Breast Cancer Patients With One Year of Letrozole.

Key Details

Gender

FEMALE

Age Range

18 Years - 69 Years

Study Type

INTERVENTIONAL

Enrollment

126

Start Date

2026-06

Completion Date

2029-07

Last Updated

2026-02-20

Healthy Volunteers

No

Interventions

DRUG

Letrozole

Letrozole is an oral aromatase inhibitor administered at a dose of 2.5 mg once daily for one year. It is used as neoadjuvant therapy in postmenopausal women with early-stage, hormone receptor-positive (ER+/PR+), HER2-negative, node-positive breast cancer to reduce tumor size and axillary lymph node involvement before surgery.

Locations (1)

Cancer Care Hospital and Research Centre Foundation

Lahore, Punjab Province, Pakistan