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NCT06806930 · ClinicalTrials.gov registry record · Phase 2
Predicting Response to Neoadjuvant Endocrine Therapy (Neo-PREDICT)
A Phase 2 study of Breast Cancer Stage II and Breast Cancer Stage III, sponsored by George Washington University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 90
- Enrollment target
- 1
- Study location
NCT06806930: Recruiting Phase 2 study of Breast Cancer Stage II and Breast Cancer Stage III, sponsored by George Washington University.
NCT06806930 is a Phase 2 study of Breast Cancer Stage II and Breast Cancer Stage III that is actively recruiting participants, run by George Washington University. The registered enrollment target is 90 participants, below the 178-participant average among 22 other Breast Cancer Stage II trials with a reported enrollment target (49% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06806930, a Phase 2 study of Breast Cancer Stage II and Breast Cancer Stage III, is actively recruiting participants, sponsored by George Washington University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 90 participants
- Enrollment target
- 1
- Study location
Study 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
Primary Outcome
Response to neoadjuvant endocrine therapy is defined as clear margins (defined as greater than 1mm) measured in the surgical pathology report. The proportion of women in each cohort with response will be estimated with exact 95% binomial confidence intervals. This is a categorical outcome (Success/Failure). Success is defined as clear margins \>1mm; Failure is defined as margins ≤1mm.
Conditions Studied
Interventions
- DRUG Neoadjuvant endocrine therapy
Study Locations (1)
District of Columbia
- George Washington-Medical Faculty Associates - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2024-10-01 |
| Est. Completion | 2028-10 |
| Phase | Phase 2 |
What NCT06806930 shows while recruiting
NCT06806930 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 178-participant average among 22 other Breast Cancer Stage II trials with a reported enrollment target (49% lower).
The record links to 4 conditions, with Breast Cancer Stage II appearing as the primary indexed condition, and to 1 intervention - of which Neoadjuvant endocrine therapy is the first listed.
NCT06806930 reports a single indexed study location in District of Columbia.
Frequently Asked Questions
What is clinical trial NCT06806930 about?
NCT06806930 is a clinical study titled "Predicting Response to Neoadjuvant Endocrine Therapy (Neo-PREDICT)". 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 ...
What is the current status of trial NCT06806930?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 2024-10-01. Estimated completion is 2028-10.
What conditions does trial NCT06806930 study?
This clinical trial studies the following conditions: Breast Cancer Stage II, Breast Cancer Stage III, Breast Cancer Stage I, Carcinoma, Breast.
What interventions are being tested in trial NCT06806930?
The interventions under investigation include: Neoadjuvant endocrine therapy (DRUG).
Who is sponsoring clinical trial NCT06806930?
This trial is sponsored by George Washington University, which has 133 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06806930 being conducted?
This trial has 1 study location across District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer Stage II
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06806930's enrollment target sits among peer trials
90 11th of 22 higher than 11 of 22 other Breast Cancer Stage II trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer Stage II trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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