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.
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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…
Contacts

Mridula A George

732-235-9692

mridula@cinj.rutgers.edu

CONTACT