NCT06806930 Predicting Response to Neoadjuvant Endocrine Therapy (Neo-PREDICT)
| NCT ID | NCT06806930 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | George Washington University |
| Condition | Breast Cancer Stage I |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2024-10-01 |
| Primary Completion | 2028-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 90 participants in total. It began in 2024-10-01 with a primary completion date of 2028-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06806930 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Breast Cancer Stage I. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06806930 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06806930 currently recruiting?
Yes, NCT06806930 is actively recruiting participants. Contact the research team at pchalasani@mfa.gwu.edu for enrollment information.
Where is the NCT06806930 trial being conducted?
This trial is being conducted at Washington D.C., United States.
Who is sponsoring the NCT06806930 clinical trial?
NCT06806930 is sponsored by George Washington University. The trial plans to enroll 90 participants.
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