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

Phase 2Active Not RecruitingNCT05150652

Irada Ibrahim-zada8 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Cancer HER2-negative Breast Cancer Node-negative Breast Cancer Breast Carcinoma

Interventions

Anastrozole 1mgDRUG

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

Letrozole 2.5mgDRUG

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

Exemestane 25 mgDRUG

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Kentucky Markey Cancer Center

Lexington, Kentucky, United States

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

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

Time frame: 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)

Time frame: 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.

Data from ClinicalTrials.gov

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