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NOT YET RECRUITING
NCT07402473
PHASE2

EUREKA Study:Phase 2 Study to Optimize Neoadjuvant Therapy in HER2-positive Early-stage Breast Cancer

Sponsor: Rutgers, The State University of New Jersey

View on ClinicalTrials.gov

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.

Official title: EUREKA Study: Phase 2 Study to Optimize Neoadjuvant Therapy in HER2-positive Early-stage Breast Cancer Using ctDNA and HARPS Biomarker Assay

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2026-03-01

Completion Date

2028-06-30

Last Updated

2026-02-11

Healthy Volunteers

No

Interventions

DRUG

Trastuzumab

Trastuzumab is a targeted antibody therapy used to treat HER2-positive breast and stomach cancers by blocking the growth-stimulating HER2 protein

DRUG

Pertuzumab

targeted therapy, a monoclonal antibody, used with other drugs (like trastuzumab and chemotherapy) to treat HER2-positive breast cancer, blocking HER2 proteins on cancer cells to stop their growth, and used for metastatic, locally advanced, or early-stage high-risk cases before or after surgery

DRUG

Docetaxel

will be used with HARPS Negative: intravenous chemotherapy medication used to treat breast, lung, prostate, gastric, and head/neck cancers

DRUG

Carboplatin

will be used with HARPS Negative: a platinum-based chemotherapy drug used primarily to treat advanced ovarian cancer, often in combination with other agents, as well as lung, head and neck, and brain cancers

Locations (7)

RWJBarnabas Health - Trinitas Hospital and Comprehensive Cancer Center

Elizabeth, New Jersey, United States

RWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton

Hamilton, New Jersey, United States

RWJBarnabas Health - Monmouth Medical Center

Long Branch, New Jersey, United States

Rutgers Cancer Institute

New Brunswick, New Jersey, United States

RWJBarnabas Health - Newark Beth Israel Medical Center

Newark, New Jersey, United States

RWJBarnabas Health - Robert Wood Johnson University Hospital, Somerset

Somerville, New Jersey, United States

RWJBarnabas Health - Community Medical Center

Toms River, New Jersey, United States