Status:
ACTIVE_NOT_RECRUITING
Pre-Operative Window of Adjuvant Endocrine Therapy to Inform RT Decisions in Older Women With Early-Stage Breast Cancer
Lead Sponsor:
Shayna Showalter, MD
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer Female
Eligibility:
FEMALE
65+ years
Phase:
PHASE2
Brief Summary
This is a prospective multisite exploratory study for women ≥ 65 years of age with early stage estrogen receptor positive (ER+) breast cancer. These individuals will be treated with 3 months of pre-op...
Detailed Description
This single arm pilot study evaluates the use of pre-operative endocrine therapy in women with early stage ER+ breast cancer who are 65 years or older and are scheduled to have breast conservation sur...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2026
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT04272801
Start Date
April 7 2020
End Date
June 1 2026
Last Update
October 22 2025
Active Locations (2)
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1
University of Virginia
Charlottesville, Virginia, United States, 22908
2
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States, 23298