Study on Pre-Operative Endocrine Therapy to Guide Radiation Decisions in Older Women with Early-Stage Breast Cancer
Sponsor: Shayna Showalter, MD
ClinicalTrials ID:NCT04272801
This study is exploring whether a short course of hormone therapy before surgery can help older women with early-stage estrogen receptor positive breast cancer decide if they need radiation treatment.
Patient Parameters
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Program Overview
This study is for women aged 65 and older who have early-stage estrogen receptor positive (ER+) breast cancer. Participants will receive hormone therapy for three months before their surgery to see how well they tolerate it. This information will help them and their doctors decide if they should skip radiation therapy after surgery. The study will use patient surveys to assess how well participants handle the hormone therapy.
Description
This study is testing a new approach for women aged 65 and older with early-stage ER+ breast cancer who are planning to have breast-conserving surgery. The study will give these women hormone therapy for three months before their surgery to see how well they tolerate it. The goal is to use this information to help decide if they can safely skip radiation therapy after surgery. Participants will fill out surveys about their experience with the hormone therapy, which will help doctors and patients make informed decisions about radiation treatment. Before starting the hormone therapy and again before surgery, both the patients and their doctors will discuss their preferences regarding radiation therapy. The study aims to see if knowing how well patients tolerate the hormone therapy affects their decision about radiation treatment.
Eligibility Criteria
Inclusion Criteria (Summary):
- ECOG performance status 0-2
- Diagnosed with anatomic stage I, ER positive, PR positive or negative, and HER2 non amplified invasive breast cancer and clinically negative nodes; any invasive breast cancer histologic subtype may be enrolled
- Tumor size ≤ 2 cm
- Patient has elected BCS as surgical choice
- Eligible to receive tamoxifen or an aromatase inhibitor
- Ability to take oral medication and be willing to adhere to the endocrine therapy for the 3 month period prior to BCS
Exclusion Criteria (Summary):
- Prior or current use of endocrine therapy for breast cancer
- History of ipsilateral breast radiation
- Pregnancy or lactation
- Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
- Current or planned use of a strong CYP2D6 inhibitor (e.g. Fluoxetine, Paroxetine) and is not able to receive an endocrine therapy agent that does not use the CYP2D6 pathway
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Virginia | 22908 | Charlottesville | Virginia |
| Virginia Commonwealth University Massey Cancer Center | 23298 | Richmond | Virginia |
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