RECRUITING

Predicting Response to Neoadjuvant Endocrine Therapy (Neo-PREDICT)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to determine how the duration of hormone blocking (endocrine) therapy given prior to surgery (called "neoadjuvant" treatment) affects breast cancer. The main questions the trial aims is answer are: 1. How breast cancer responds to endocrine therapy given prior to surgery? 2. To predict tumor pre-operative endocrine prognostic index (PEPI) score for subjects enrolled in cohort B or C Participants with early-stage breast cancer (Stage I-III) who are eligible for Neoadjuvant Endocrine Therapy (NET) will be enrolled in the study. Participants will: * receive endocrine therapy as part of regular care for breast cancer * consent to samples of blood and tissue evaluation to determine how endocrine therapy effects the tumor * participate in this research anywhere from 2 weeks to 1 year, depending on duration of endocrine therapy and when surgery will be performed

Official Title

Predicting Response to Neoadjuvant Endocrine Therapy (Neo-PREDICT)

Quick Facts

Study Start:2024-10-03
Study Completion:2028-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06806930

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Be capable of understanding the investigational nature of the study and all pertinent aspects of the study
  2. * Be capable of signing and providing written consent in accordance with institutional and federal guidelines
  3. * Histologically or cytologically confirmed diagnosis of invasive carcinoma of the breast
  4. * Clinical stage 1 to 3 breast cancer
  5. * Candidate for surgical resection
  6. * Estrogen receptor \> 10% positive stained cells based on most recent tumor biopsy and documented by a local laboratory or medical record.
  7. * 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.
  8. * Ability to take oral medication
  9. * Be willing and able to comply with scheduled visits, treatment plan, and follow up with research staff
  10. * Age ≥ 21 years
  1. * Inability to comply taking NET
  2. * Inability to comply to study procedures

Contacts and Locations

Study Contact

Pavani Chalasani, MD
CONTACT
202-741-2277
pchalasani@mfa.gwu.edu

Study Locations (Sites)

George Washington-Medical Faculty Associates
Washington, District of Columbia, 20037
United States

Collaborators and Investigators

Sponsor: George Washington University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-03
Study Completion Date2028-10

Study Record Updates

Study Start Date2024-10-03
Study Completion Date2028-10

Terms related to this study

Keywords Provided by Researchers

  • breast
  • cancer
  • HER2
  • carcinoma

Additional Relevant MeSH Terms

  • Breast Cancer Stage I
  • Breast Cancer Stage II
  • Breast Cancer Stage III
  • Carcinoma, Breast