Predicting how hormone therapy before surgery affects 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 clinical trial aims to evaluate the effectiveness of neoadjuvant endocrine therapy in patients with early-stage breast cancer (Stages I-III) prior to surgical intervention. Participants will receive hormone-blocking treatment as part of their standard care and will provide blood and tissue samples to assess the therapy's impact on their tumors. The study will focus on predicting the tumor's pre-operative endocrine prognostic index (PEPI) score based on the response to the therapy. The duration of participation will vary from 2 weeks to 1 year, depending on the length of the therapy and timing of surgery.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Be capable of understanding the investigational nature of the study and all pertinent aspects of the study
* Be capable of signing and providing written consent in accordance with institutional and federal guidelines
* Histologically or cytologically confirmed diagnosis of invasive carcinoma of the breast
* Clinical stage 1 to 3 breast cancer
* Candidate for surgical resection
* Estrogen receptor \> 10% positive stained cells based on most recent tumor biopsy and documented by a local laboratory or medical record.
* HER2 negative or HER2 low breast cancer based on the most recent tumor biopsy and documented by a local laboratory or medical record. HER2 negative tumor is defined per American Society of Clinical Oncology and the College of American Pathologists guidelines, 2018. Patients with HER2 low tumors are eligible as long as patients are not candidates for any HER2 directed therapy.
* Ability to take oral medication
* Be willing and able to comply with scheduled visits, treatment plan, and follow up with research staff
* Age ≥ 21 years

Exclusion Criteria:

* Inability to comply taking NET
* Inability to comply to study procedures

Where it's running

• George Washington-Medical Faculty Associates
  Washington D.C., District of Columbia, United States Recruiting

Study contacts

• Study coordinator: Pavani Chalasani, MD
• Email: pchalasani@mfa.gwu.edu
• Phone: 202-741-2277

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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.