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

Sponsor: Veronica Morgan Jones

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05150652

Patient View

This study evaluates neoadjuvant endocrine therapy's impact on margin negativity in lumpectomy specimens. Eligible participants are postmenopausal women with stage I-II, ER-positive, HER2-negative breast cancer, and no lymph node involvement. Interventions include daily oral doses of Anastrozole, Letrozole, Exemestane, or Tamoxifen for up to six 28-day cycles. Participants must consent to join.

Patient Parameters

Program Overview

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 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

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