Pre-operative endocrine therapy for older women with early-stage breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase III, multisite exploratory study focuses on women aged 65 and older with early-stage estrogen receptor positive (ER+) breast cancer. Participants will be randomly assigned to either receive 90 days of pre-operative endocrine therapy or proceed directly to breast cancer surgery without prior treatment. The study aims to assess the tolerance and compliance to endocrine therapy through patient-reported outcomes. The goal is to determine if pre-operative therapy can inform decisions regarding the necessity of radiation therapy post-surgery.

Why it matters

Who can join: the full rules

Inclusion Criteria (summary):

* Diagnosis of ER+, PR +/-, and HER2- non amplified invasive breast cancer and clinically negative nodes
* ECOG performance status 0-2
* Females, aged ≥ 65 years
* Patient is eligible for BCS and opted for BCS
* Patient is a candidate for radiation therapy
* Patient is a candidate for endocrine therapy (tamoxifen or an aromatase inhibitor)
* Ability to take oral medication and be willing to adhere to endocrine therapy for the 3-month period prior to BCS
* Agreement to adhere to Lifestyle Considerations (details in protocol) throughout study duration
* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria:

* Bilateral synchronous breast cancer
* Multicentric disease
* Prior use of Tamoxifen or aromatase inhibitors
* History of ipsilateral breast radiation therapy
* Has a known additional malignancy that is progressing and/or requires active treatment with cytotoxic chemotherapy or radiation therapy. Malignancies deemed stable and low risk for complication per investigator's judgment may be allowed after discussion with multi-site PI.
* Current or planned use of a strong CYP2D6 inhibitor (e.g., Fluvoxamine, Paroxetine) and is not able to receive an endocrine therapy agent that does not use the CYP2D6 pathway.

Where it's running

• Yale University
  New Haven, Connecticut, United States Recruiting
• University of Virginia
  Charlottesville, Virginia, United States Recruiting
• University of Virginia Community Health
  Culpeper, Virginia, United States Recruiting
• INOVA Schar Cancer
  Fairfax, Virginia, United States Recruiting
• Riverside Health System
  Newport News, Virginia, United States Recruiting
• Virginia Commonwealth University
  Richmond, Virginia, United States Recruiting

Study contacts

• Principal investigator: Shayna L Showalter, MD — University of Virginia
• Study coordinator: Meagan Miller
• Email: aey8fc@uvahealth.org
• Phone: 434-243-8101

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.