Predicting how hormone therapy before surgery affects breast cancer
Predicting Response to Neoadjuvant Endocrine Therapy (Neo-PREDICT)
This study is testing how hormone therapy before surgery can help people with early-stage breast cancer and what it means for their tumors.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | George Washington University Academic / other |
| Locations | 1 site (Washington D.C., District of Columbia) |
| Trial ID | NCT06806930 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals with invasive breast carcinoma at clinical stages I to III who are eligible for neoadjuvant endocrine therapy.
Not a fit: Patients with HER2 positive breast cancer or those not eligible for endocrine therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved personalized treatment strategies for patients with early-stage breast cancer.
How similar studies have performed: Other studies have shown promise in using neoadjuvant endocrine therapy for breast cancer, indicating that this approach is supported by prior research.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Washington D.C., District of Columbia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.