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

Phase 2 Study of 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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Breast Carcinoma; HER2-negative Breast Cancer; Node-negative Breast Cancer
• Intervention / Treatment: Drug: Anastrozole 1mg; Drug: Letrozole 2.5mg; Drug: Exemestane 25 mg; Drug: Tamoxifen

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yvonne E Taul, RN; Phone Number: 859-323-2354; Email: yvonne.taul@uky.edu

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • Recruiting
      • University of Kentucky Markey Cancer Center
      • Contact: Erin E Burke, MD; Phone Number: 859-323-2222; Email: erin.burke@uky.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in margin status	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.	Baseline, 6-months after neoadjuvant treatment and surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Residual cancer burden	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	After neoadjuvant treatment and surgery (approximately 6 months from diagnosis)
Pattern of response	Pattern of response (pathologic complete response, concentric shrinking with similar cellularity, size unchanged with decreased cellularity, no treatment response)	After neoadjuvant treatment and surgery (approximately 6 months from diagnosis)
Change in satisfaction with cosmetic outcome	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.	After neoadjuvant treatment and surgery (approximately 6 months and 12 months post-surgery)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in largest caliper measurement	Largest caliper measurement (millimeters) on post-therapy imaging vs. largest final size of tumor	Baseline, 6-months after neoadjuvant treatment and surgery

Collaborators and Investigators

• Sponsor: Veronica Morgan Jones
• Investigators: Principal Investigator: Veronica M Jones, MD, University of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2022
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2036

Study Registration Dates

• First Submitted: November 24, 2021
• First Submitted That Met QC Criteria: December 8, 2021
• First Posted (Actual): December 9, 2021

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 26, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Early stage; Neoadjuvant endocrine therapy
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Hormone Antagonists; Bone Density Conservation Agents; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Estrogen Antagonists; Selective Estrogen Receptor Modulators; Estrogen Receptor Modulators; Letrozole; Tamoxifen; Anastrozole; Exemestane
• Other Study ID Numbers: MCC-21-BRE-54

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No