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 (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-pos

Trial Details

NCT ID
NCT07402473
Phase
PHASE2
Sponsor
Rutgers, The State University of New Jersey
Status
RECRUITING
Cancer Type
HER2 Positive Breast Cancer
Interventions
  • Trastuzumab
  • Pertuzumab
  • Docetaxel
  • Carboplatin
Locations (sample)
  • Elizabeth, New Jersey, United States|40.66399,-74.2107
  • Hamilton, New Jersey, United States|40.20706,-74.08125
  • Long Branch, New Jersey, United States|40.30428,-73.99236
  • New Brunswick, New Jersey, United States|40.48622,-74.45182
  • Newark, New Jersey, United States|40.73566,-74.17237

Key Eligibility Criteria

  • Inclusion Criteria
  • Tumor size greater than 2cm or lymph node positive by imaging or clinical exam (cT2-T3 N0-2)
  • Tumors must be HER2 positive either by IHC (3+) or by IHC 2+ and FISH positive.
  • Patient must have known estrogen receptor (ER) and progesterone receptor (PR) status locally determined prior to study entry

For full eligibility, visit ClinicalTrials.gov.

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