MedTrace Logo

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

NCT07394946 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2026-02-20

No results posted yet for this study

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

Conditions

  • Hormone Receptor-Positive, HER2-Negative, Node Positive Breast Cancer

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.

Sponsors & Collaborators

  • Cancer Care Hospital & Research Centre Foundation, Lahore

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2027-07-31
Completion
2029-07-31

Countries

  • Pakistan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07394946 on ClinicalTrials.gov