Optimize Neoadjuvant Therapy in HER2-Positive Early-Stage Breast Cancer
Recruiting
Phase 2
Interventional Study
HER2-positive Early-stage Breast Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 90
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 50 (estimated)
- Sponsor
- Rutgers, The State University of New Jersey · Other
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About This Trial
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 (…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Inclusion Criteria
1. Tumor size greater than 2cm or lymph node positive by imaging or clinical exam (cT2-T3 N0-2)
2. Tumors must be HER2 positive either by IHC (3+) or by IHC 2+ and FISH positive.
3. Patient must have known estrogen receptor (ER) and progesterone recep…
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