Letrozole in Post-Menopausal Patients With Operable Hormone-Sensitive Breast Cancer

What this trial studies

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.

Conditions in scope

• Breast Cancer Female

Interventions

• Letrozole (Drug) — Patients will receive a prescription for letrozole to be taken orally 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…

Who can join

Women only · Ages 18 Years and up

Inclusion criteria

• See ClinicalTrials.gov for full inclusion criteria.

Exclusion criteria

• Patients must provide informed written consent
• ECOG performance status 0-2.
• Clinical stage operable I, II or III invasive mammary carcinoma, which is ER-positive by IHC and HER2-negative by Herceptest (0 or 1+) or not amplified by in situ hybridization as per routine clinical testing.
• Patients who have measurable residual tumor at the primary site
• Patients who will undergo surgical treatment with either segmental resection or total mastectomy
• Measurable tumor. Measurable disease: a mass that can be reproducibly measured by physical exam, mammogram or ultrasound and is at least 1 cm in size
• Post-menopausal female subjects ≥18 years of age, as defined by any of the following:
• Subjects at least 55 years of age;

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Completed
• Study type: Interventional
• Phase: PHASE2
• Start date: 2018-11-27
• Primary completion: 2025-02-24
• Last update posted: 2026-03-16
• First posted: 2018-11-20

Sponsor & contact

Lead sponsor: University of Texas Southwestern Medical Center (Other)

Collaborators: Cancer Prevention Research Institute of Texas

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Measure Ki67 Index in Highly Hormone-dependent Breast Cancers vs. Those That Are Not (Within 8 to 30 days)
  Ki67 index measured 1-4 weeks after therapy with letrozole to segregate hormone receptor-positive breast cancers that are highly hormone-dependent vs. those that are not

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.