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Study identifier: NCT07402473 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Optimize Neoadjuvant Therapy in HER2-Positive Early-Stage Breast Cancer

Condition: HER2-positive Early-stage Breast Cancer  ·  Sponsor: Rutgers, The State University of New Jersey

PhasePhase 2
Planned participants50
Who can joinAll sexes, 18 Years to 90 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Mridula A George  ·  732-235-9692  ·  mridula@cinj.rutgers.edu

Always discuss trial participation with your own doctor first.

Locations (7)

RWJBarnabas Health - Trinitas Hospital and Comprehensive Cancer CenterElizabeth, New Jersey, United StatesRecruiting
RWJBarnabas Health - Robert Wood Johnson University Hospital, HamiltonHamilton, New Jersey, United StatesRecruiting
RWJBarnabas Health - Monmouth Medical CenterLong Branch, New Jersey, United StatesRecruiting
Rutgers Cancer InstituteNew Brunswick, New Jersey, United StatesRecruiting
RWJBarnabas Health - Newark Beth Israel Medical CenterNewark, New Jersey, United StatesRecruiting
RWJBarnabas Health - Robert Wood Johnson University Hospital, SomersetSomerville, New Jersey, United StatesRecruiting
RWJBarnabas Health - Community Medical CenterToms River, New Jersey, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT07402473