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

Last updated: March 25, 2025
Sponsor: Irada Ibrahim-zada
Overall Status: Active - Recruiting

Phase

2

Condition

Cancer/tumors

Breast Cancer

Carcinoma

Treatment

Exemestane 25 mg

Tamoxifen

Letrozole 2.5mg

Clinical Study ID

NCT05150652
MCC-21-BRE-54
  • Ages 18-99
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 consentdocument

Exclusion

Exclusion Criteria:

  • Progesterone receptor negativity

  • High grade tumor

  • Synchronous non-breast malignancy

  • Receiving any other investigational agents that could impact the efficacy of thistrial regimen

  • History of allergic reactions attributed to compounds of similar chemical orbiologic composition to Anastrozole, Letrozole, Exemestane, Tamoxifen or otheragents used in study

  • Uncontrolled intercurrent illness

  • Medical, psychiatric or other condition and/or social situations that would limitcompliance with study requirements

Study Design

Total Participants: 70
Treatment Group(s): 4
Primary Treatment: Exemestane 25 mg
Phase: 2
Study Start date:
February 18, 2022
Estimated Completion Date:
October 31, 2036

Connect with a study center

  • University of Kentucky Markey Cancer Center

    Lexington, Kentucky 40536
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.