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Active, Not Recruiting

NCT Number: NCT05150652

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Breast Cancer Breast Carcinoma Breast Diseases Breast Neoplasms HER2-negative Breast Cancer Neoplasms Neoplasms by Site Node-negative Breast Cancer Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

University of Kentucky Markey Cancer Center

Lexington, Kentucky, 40536, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anastrozole 1mg

Drug

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

Other names: Arimidex

Letrozole 2.5mg

Drug

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

Other names: Femara

Exemestane 25 MG

Drug

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

Other names: Aromasin

Tamoxifen

Drug

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

Other names: Soltamox

Primary outcomes

  1. Change in margin status

    Time frame: Baseline, 6-months after neoadjuvant treatment and surgery

    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.

Secondary outcomes

  1. Residual cancer burden

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

    The following parameters are required from pathologic examination in order to calculate Residual Cancer Burden (RCB) after neoadjuvant treatment: Primary tumor bed area, overall cancer cellularity (as percentage of area), percentage of cancer that is in situ disease, number of positive lymph nodes and diameter of largest metastasis. These parameters are filled in in the calculator that is available online to calculate the Residual Cancer Burden index: http://www3.mdanderson.org/app/medcalc/index.cfm?pagename=jsconvert3

  2. Pattern of response

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

    Pattern of response (pathologic complete response, concentric shrinking with similar cellularity, size unchanged with decreased cellularity, no treatment response)

  3. Change in satisfaction with cosmetic outcome

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

    The Breast-Q© is a patient reported outcome measure for breast surgery that measures patient reported satisfaction and quality of life (QOL) developed by Memorial Sloan Kettering Cancer Center. It is comprised of 10 scales that address: 1) psychosocial well-being, 2) sexual well-being, 3) satisfaction with breasts, 4) physical well-being, 5) adverse effects of radiation, 6) satisfaction with information - breast surgeon, 7) satisfaction with information - radiation oncologist, 8) satisfaction with surgeon, 9) satisfaction with medical team, 10) satisfaction with office staff. Each module is scored from 0-100 where higher scores reflect a better outcome.

Other outcomes

  1. Change in largest caliper measurement

    Time frame: Baseline, 6-months after neoadjuvant treatment and surgery

    Largest caliper measurement (millimeters) on post-therapy imaging vs. largest final size of tumor

Sponsors and collaborators

Lead sponsor

Irada Ibrahim-zada

Other

Registry information

Official study title

Phase 2 Study of Neoadjuvant Endocrine Therapy in ER-positive, HER2-negative Early Stage Breast Cancer

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Dec 9, 2021
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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