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NCT07402473 · ClinicalTrials.gov registry record · Phase 2
Optimize Neoadjuvant Therapy in HER2-Positive Early-Stage Breast Cancer
A Phase 2 study, sponsored by Rutgers, The State University of New Jersey.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
NCT07402473: Recruiting Phase 2 study, sponsored by Rutgers, The State University of New Jersey.
NCT07402473 is a Phase 2 study that is actively recruiting participants, run by Rutgers, The State University of New Jersey. The registered enrollment target is 50 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07402473, a Phase 2 study, is actively recruiting participants, sponsored by Rutgers, The State University of New Jersey.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
Study Summary
This is an open-label phase 2 study to evaluate the pCR rate in patients diagnosed with HER2 positive breast cancer treated on an adaptive clinical trial design. Tumors will undergo testing using a novel molecular phosphoprotein-based biomarker assay, HER2 Activation Response Predictive Signature (HARPS) to identify HARPS-positive breast cancers. To assess 3-year invasive disease-free survival (iDFS) in patients with HARPS-positive and HARPS-negative HER2-positive breast cancer. To correlate changes in ctDNA with treatment outcomes in patients with HARPS-positive and HARPS-negative HER2-positive breast cancer. To understand the changes in quality of life (QOL) measure in patients with HARPS-positive HER2-positive breast cancer treated using an adaptive neoadjuvant trial design.
Primary Outcome
The HARPS assay will be used to identify patients with HARPS positive and HARPS-negative HER2-positive breast cancer. Patients with Stage I-III who meet the specified eligibility criteria would be enrolled in the adaptive clinical trial. The study aims to understand whether the HARPS assay can help optimize the treatment regimen for patients diagnosed with HER2 positive breast cancer. The study will evaluate the pCR rates in patients treated with the adaptive trial regimen. The hypothesis of t
Interventions
- DRUG Trastuzumab
- DRUG Carboplatin
- DRUG Docetaxel
- DRUG Pertuzumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2026-03-26 |
| Est. Completion | 2028-06-30 |
| Phase | Phase 2 |
What NCT07402473 shows while recruiting
NCT07402473 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 4 interventions - of which Trastuzumab is the first listed.
NCT07402473 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07402473 about?
NCT07402473 is a clinical study titled "Optimize Neoadjuvant Therapy in HER2-Positive Early-Stage Breast Cancer". This is an open-label phase 2 study to evaluate the pCR rate in patients diagnosed with HER2 positive breast cancer treated on an adaptive clinical trial design. Tumors will undergo testing using a novel molecular phosphoprotein-based biomarker assay, HER2 Activation Response Predictive Signature (...
What is the current status of trial NCT07402473?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2026-03-26. Estimated completion is 2028-06-30.
What interventions are being tested in trial NCT07402473?
The interventions under investigation include: Trastuzumab (DRUG), Carboplatin (DRUG), Docetaxel (DRUG), Pertuzumab (DRUG).
Who is sponsoring clinical trial NCT07402473?
This trial is sponsored by Rutgers, The State University of New Jersey, which has 413 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07402473's enrollment target sits among peer trials
50 1195th of 2000 higher than 740 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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