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

Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 99 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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 consent document

Exclusion Criteria

  • 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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Neoadjuvant Endocrine Therapy 		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
    Participants will take 1mg of anastrozole once daily, orally, for up to six cycles of 28 days.
    Other names:
    • Arimidex
  • Drug: Letrozole 2.5mg
    Participants will take 2.5mg of Letrozole once daily, orally, for up to six cycles of 28 days.
    Other names:
    • Femara
  • Drug: Exemestane 25 mg
    Participants will take 25mg of Exemestane once daily, orally, for up to six cycles of 28 days.
    Other names:
    • Aromasin
  • Drug: Tamoxifen
    Participants will take 20mg of Tamoxifen once daily, orally, for up to six cycles of 28 days.
    Other names:
    • Soltamox

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky Markey Cancer Center
Lexington, Kentucky 40536
Contact:
Erin E Burke, MD
859-323-2222
erin.burke@uky.edu

More Details

NCT ID
NCT05150652
Status
Recruiting
Sponsor
Veronica Morgan Jones

Study Contact

Yvonne E Taul, RN
859-323-2354
yvonne.taul@uky.edu