Study on Predicting Response to Hormone Therapy Before Surgery for Breast Cancer (Neo-PREDICT)

Sponsor: George Washington University

Sponsor score: 0

ClinicalTrials ID:NCT06806930

This clinical trial is exploring how breast cancer responds to hormone-blocking therapy given before surgery. It aims to understand the effects of this treatment on early-stage breast cancer and predict outcomes based on specific tumor characteristics.

Patient Parameters

Parameter	Options

Program Overview

The purpose of this study is to find out how breast cancer responds to hormone-blocking therapy, known as endocrine therapy, when given before surgery. This type of treatment is called neoadjuvant therapy. The study will also try to predict a score that helps understand the tumor's response to this therapy. Participants with early-stage breast cancer (Stage I-III) who are eligible for this type of therapy will be part of the study. They will receive hormone therapy as part of their regular cancer care and provide blood and tissue samples to see how the therapy affects the tumor. The study duration can range from 2 weeks to 1 year, depending on how long the therapy is given and when surgery is scheduled.

Eligibility Criteria

Inclusion Criteria

Understand the study and its details.
Be able to sign a consent form.
Have a confirmed diagnosis of invasive breast cancer.
Have Stage I to III breast cancer.
Be a candidate for surgery.
Have a tumor with more than 10% estrogen receptor-positive cells.
Have HER2 negative or low breast cancer.
Be able to take oral medication.
Be willing to attend scheduled visits and follow the treatment plan.
Be 21 years or older.

Exclusion Criteria

Unable to take hormone therapy as required.
Unable to follow study procedures.

Locations

FACILITY	ZIP	CITY	STATE
George Washington-Medical Faculty Associates	20037	Washington	District of Columbia

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