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

Last updated: January 6, 2026
Sponsor: Irada Ibrahim-zada
Overall Status: Active - Not Recruiting

Phase

2

Condition

Breast Cancer

Carcinoma

Cancer/tumors

Treatment

Tamoxifen

Letrozole 2.5mg

Anastrozole 1mg

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: 8
Treatment Group(s): 4
Primary Treatment: Tamoxifen
Phase: 2
Study Start date:
February 18, 2022
Estimated Completion Date:
June 09, 2026

Connect with a study center

  • University of Kentucky Markey Cancer Center

    Lexington, Kentucky 40536
    United States

    Site Not Available

  • University of Kentucky Markey Cancer Center

    Lexington 4297983, Kentucky 6254925 40536
    United States

    Site Not Available

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