Neoadjuvant Endocrine Therapy in ER-positive, HER2-negative Early Stage Breast Cancer

NCT05150652 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: MCC-21-BRE-54
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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; Node-negative Breast Cancer; HER2-negative Breast Cancer; Breast Carcinoma

Keywords

Neoadjuvant endocrine therapy; Early stage

Outcome Measures

Primary Outcomes (1)

• Change in margin status

  Evaluate the effect of neoadjuvant endocrine therapy (6-months course) on margin status of breast conservation surgery for women with early stage, low-risk breast cancer, defined as ER-positive, HER2-negative, node-negative breast carcinoma (single lesion only). Negative margin status is defined as no tumor on ink.

  Baseline, 6-months after neoadjuvant treatment and surgery

Secondary Outcomes (3)

• Residual cancer burden

  After neoadjuvant treatment and surgery (approximately 6 months from diagnosis)

• Pattern of response

  After neoadjuvant treatment and surgery (approximately 6 months from diagnosis)

• Change in satisfaction with cosmetic outcome

  After neoadjuvant treatment and surgery (approximately 6 months and 12 months post-surgery)

Other Outcomes (1)

• Change in largest caliper measurement

  Baseline, 6-months after neoadjuvant treatment and surgery

Study Arms (1)

Neoadjuvant Endocrine Therapy

EXPERIMENTAL

Participants will begin treatment with Anastrozole. If not tolerated well, participants will discontinue and begin treatment using Letrozole. If not tolerated well, participants will discontinue and begin treatment using Exemestane. If not tolerated well, participants will discontinue and begin treatment on Tamoxifen.

Drug: Anastrozole 1mg; Drug: Letrozole 2.5mg; Drug: Exemestane 25 mg; Drug: Tamoxifen

Interventions

Anastrozole 1mg DRUG

Participants will take 1mg of anastrozole once daily, orally, for up to six cycles of 28 days.

Also known as: Arimidex

Neoadjuvant Endocrine Therapy

Letrozole 2.5mg DRUG

Participants will take 2.5mg of Letrozole once daily, orally, for up to six cycles of 28 days.

Also known as: Femara

Neoadjuvant Endocrine Therapy

Exemestane 25 mg DRUG

Participants will take 25mg of Exemestane once daily, orally, for up to six cycles of 28 days.

Also known as: Aromasin

Neoadjuvant Endocrine Therapy

Tamoxifen DRUG

Participants will take 20mg of Tamoxifen once daily, orally, for up to six cycles of 28 days.

Also known as: Soltamox

Neoadjuvant Endocrine Therapy

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically confirmed invasive breast cancer, clinically stage I-II.
• Clinically lymph node negative
• Eligible for anti-endocrine treatment (per medical oncologist)
• Postmenopausal women
• Ability to understand and the willingness to sign a written informed consent document

You may not qualify if:

• Progesterone receptor negativity
• High grade tumor
• Synchronous non-breast malignancy
• Receiving any other investigational agents that could impact the efficacy of this trial regimen
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to Anastrozole, Letrozole, Exemestane, Tamoxifen or other agents used in study
• Uncontrolled intercurrent illness
• Medical, psychiatric or other condition and/or social situations that would limit compliance with study requirements

Sponsors & Collaborators

• Irada Ibrahim-zada: lead

Study Sites (1)

University of Kentucky Markey Cancer Center

Lexington, Kentucky, 40536, United States

Location

Related Publications (1)

• McDonald HG, Cassim EB, Harper MM, Burke EE, Marcinkowski EF, Cavnar MJ, Pandalai PK, Kim J. The Development of Investigator-Initiated Clinical Trials in Surgical Oncology. Surg Oncol Clin N Am. 2023 Jan;32(1):13-25. doi: 10.1016/j.soc.2022.07.003. Epub 2022 Nov 3.

  PMID: 36410913 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Anastrozole; Letrozole; exemestane; Tamoxifen

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Irada Ibrahim-zada, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: December 9, 2021
• Study Start: February 18, 2022
• Primary Completion: December 9, 2025
• Study Completion (Estimated): June 9, 2026
• Last Updated: January 7, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)