Pre-Operative Window of Adjuvant Endocrine Therapy to Inform RT Decisions in Older Women With Early-Stage Breast Cancer
- Conditions
- Breast Cancer Female
- Registration Number
- NCT04272801
- Lead Sponsor
- Shayna Showalter, MD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- Female
- Target Recruitment
- 83
Inclusion Criteria (Summary):<br><br> - ECOG performance status 0-2<br><br> - Diagnosed with anatomic stage I, ER positive, PR positive or negative, and HER2 non<br> amplified invasive breast cancer and clinically negative nodes; any invasive breast<br> cancer histologic subtype may be enrolled<br><br> - Tumor size = 2 cm<br><br> - Patient has elected BCS as surgical choice<br><br> - Eligible to receive tamoxifen or an aromatase inhibitor<br><br> - Ability to take oral medication and be willing to adhere to the endocrine therapy<br> for the 3 month period prior to BCS<br><br>Exclusion Criteria (Summary):<br><br> - Prior or current use of endocrine therapy for breast cancer<br><br> - History of ipsilateral breast radiation<br><br> - Pregnancy or lactation<br><br> - Has a known additional malignancy that is progressing or requires active treatment.<br> Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of<br> the skin that has undergone potentially curative therapy or in situ cervical cancer.<br><br> - Current or planned use of a strong CYP2D6 inhibitor (e.g. Fluoxetine, Paroxetine)<br> and is not able to receive an endocrine therapy agent that does not use the CYP2D6<br> pathway
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in participant preference for adjuvant radiation treatment;Change in surgeon preference for adjuvant radiation treatment
- Secondary Outcome Measures
Name Time Method