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NCT05837455 · ClinicalTrials.gov registry record · Phase 2
NeoTAILOR: ABiomarker-directed Approach to Guide Neoadjuvant Therapy for Patients With Stage II/III ER-positive, HER2-negative Breast Cancer
A Phase 2 study of Breast Cancer and Cancer of the Breast, sponsored by Washington University School of Medicine.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 81
- Enrollment target
- 1
- Study location
NCT05837455 is a Phase 2 study of Breast Cancer and Cancer of the Breast that is actively recruiting participants, run by Washington University School of Medicine. The registered enrollment target is 81 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05837455, a Phase 2 study of Breast Cancer and Cancer of the Breast, is actively recruiting participants, sponsored by Washington University School of Medicine.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 81 participants
- Enrollment target
- 1
- Study location
Study Summary
This study aims to utilize a novel biomarker-driven approach to guide neoadjuvant treatment selection. It is the hypothesis that this will improve clinical response for postmenopausal women with clinical stage II/III ER-positive, HER2-negative breast cancer and identify those who may not require neoadjuvant chemotherapy, with a primary focus on outcomes in Black patients.
Conditions Studied
Interventions
- DRUG Anastrozole
- DEVICE VENTANA MIB-1 Ki67 assay
- DEVICE Oncotype DX® Recurrence Score
- DEVICE PAM50-based Prosigna breast cancer gene signature assay
- DRUG Combination anthracycline and/or taxane based treatment
Study Locations (1)
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2024-05-30 |
| Est. Completion | 2027-11-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05837455
The ClinicalTrials.gov registry entry for NCT05837455 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 81 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower). The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Anastrozole is the first listed.
NCT05837455 reports 1 study location spanning 1 distinct geographic area - top geographies include Missouri.
Frequently Asked Questions
What is clinical trial NCT05837455 about?
NCT05837455 is a clinical study titled "NeoTAILOR: ABiomarker-directed Approach to Guide Neoadjuvant Therapy for Patients With Stage II/III ER-positive, HER2-negative Breast Cancer". This study aims to utilize a novel biomarker-driven approach to guide neoadjuvant treatment selection. It is the hypothesis that this will improve clinical response for postmenopausal women with clinical stage II/III ER-positive, HER2-negative breast cancer and identify those who may not require neo...
What is the current status of trial NCT05837455?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 81 participants. The study started on 2024-05-30. Estimated completion is 2027-11-30.
What conditions does trial NCT05837455 study?
This clinical trial studies the following conditions: Breast Cancer, Cancer of the Breast.
What interventions are being tested in trial NCT05837455?
The interventions under investigation include: Anastrozole (DRUG), VENTANA MIB-1 Ki67 assay (DEVICE), Oncotype DX® Recurrence Score (DEVICE), PAM50-based Prosigna breast cancer gene signature assay (DEVICE), Combination anthracycline and/or taxane based treatment (DRUG).
Who is sponsoring clinical trial NCT05837455?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05837455 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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