Neoadjuvant Endocrine Therapy in ER-positive, HER2-negative Early Stage Breast Cancer
NCT05150652 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8
Last updated 2026-01-07
Summary
The goal of this study is to access whether treatment of early state estrogen-rich breast cancers with neoadjuvant endocrine therapy will result in higher rates of margin negativity on lumpectomy specimen.
Conditions
- Breast Cancer
- HER2-negative Breast Cancer
- Node-negative Breast Cancer
- Breast Carcinoma
Interventions
- DRUG
-
Anastrozole 1mg
Participants will take 1mg of anastrozole once daily, orally, for up to six cycles of 28 days.
- DRUG
-
Letrozole 2.5mg
Participants will take 2.5mg of Letrozole once daily, orally, for up to six cycles of 28 days.
- DRUG
-
Exemestane 25 mg
Participants will take 25mg of Exemestane once daily, orally, for up to six cycles of 28 days.
- DRUG
-
Tamoxifen
Participants will take 20mg of Tamoxifen once daily, orally, for up to six cycles of 28 days.
Sponsors & Collaborators
-
Irada Ibrahim-zada
lead OTHER
Principal Investigators
-
Irada Ibrahim-zada, MD · University of Kentucky
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 99 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-02-18
- Primary Completion
- 2025-12-09
- Completion
- 2026-06-09
- FDA Drug
- Yes
Countries
- United States
Study Locations
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