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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: Recruiting Phase 2 study of Breast Cancer and Cancer of the Breast, sponsored by Washington University School of Medicine.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
* ORR is defined as patients achieving clinical complete response (CR) or partial response (PR) according to RECIST v1.1. * Complete Response (CR): disappearance of all target and non-target lesions. Residual lesions thought to be non-malignant should be further investigated before CR can be accepted. * Partial Response (PR): ≥30% decrease in the sum of measures of target lesions, taking as reference the baseline sum of diameters. Non-target lesions must be non-PD.
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 |
What NCT05837455 shows while recruiting
NCT05837455 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT05837455's enrollment target sits among peer trials
81 644th of 1224 higher than 577 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer 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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