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

Recruiting now · Phase 2

Conditions studied: HER2-positive Early-stage Breast Cancer

In brief

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.

Key facts

Study ID

NCT07402473

Run by

Rutgers, The State University of New Jersey

People needed

50

Starts

2026-03-26

Expected to finish

2028-06-30

Last updated by the study team

2026-04-23

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Patient must have adequate tumor for HARPS testing.
• Patients must have ctDNA collection prior to treatment on trial.
• Patient must be able to do breast MRI as determined by the study
• Baseline LVEF > 50% (Most recent within the last 5 years)
• No prior history of systemic treatment with anthracyclines-based chemotherapy.
• Adequate bone marrow function:
• ANC ≥ 1500/uL
• platelet count ≥ 100,000/uL
• hemoglobin ≥ 9.0 g/dL
• Adequate hepatic function:
• Total bilirubin ≤ 1.5 X ULN
• AST (SGOT) ≤ 5 X ULN
• ALT (SGPT) ≤ 5 X ULN
• Patients with biliary obstruction must have restored biliary flow by placement of an endoscopic common bile duct stent or a percutaneous drainage.
• Adequate renal function, Creatinine < 1.5x institutional ULN or calculated creatinine clearance ≥ 50 mL/min as estimated using the Cockcroft-Gault formula.
• Ability to understand the nature of this study protocol and give written informed consent.
• Willingness and ability to comply with scheduled visits and treatment plans
• Prior cancers allowed if no evidence of disease in last 5 years. Prior history of ipsilateral invasive breast cancers are not allowed.

You may not qualify if…

• Previous treatment with chemotherapy, anti-HER2 therapy, radiation therapy, or endocrine therapy for invasive breast cancer. Exception: patients can start upto 1 cycle of HP prior to starting treatment on study.
• cT4 and/or cN3 tumors
• Evidence of metastatic disease by routine clinical assessment
• Bilateral breast cancer
• History of other malignancy within the last five years prior to first dose of study drug administration, except for curatively treated basal and squamous cell carcinoma of the skin and/or in situ cervical carcinoma
• Left ventricular ejection fraction (LVEF) below 50% as determined by multiple-gated acquisition (MUGA) scan or echocardiography (ECHO)
• No active liver disease.
• Any condition including the presence of laboratory abnormalities, which, in the opinion of the investigator places the subject at unacceptable risk if he/she were to participate in the study.
• Pre-existing sensory neuropathy > grade 1.
• Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 6 months.
• Serious non-healing wound, ulcer, or bone fracture
• Patient with uncontrolled and/ or active infection with HIV, Hepatitis B or Hepatitis C.
• Patient who has a history of allergy or hypersensitivity to any of the study drugs.
• Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study

Where it is running

• RWJBarnabas Health - Trinitas Hospital and Comprehensive Cancer Center — Elizabeth, New Jersey, United States (enrolling)
• RWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton — Hamilton, New Jersey, United States (enrolling)
• RWJBarnabas Health - Monmouth Medical Center — Long Branch, New Jersey, United States (enrolling)
• Rutgers Cancer Institute — New Brunswick, New Jersey, United States (enrolling)
• RWJBarnabas Health - Newark Beth Israel Medical Center — Newark, New Jersey, United States (enrolling)
• RWJBarnabas Health - Robert Wood Johnson University Hospital, Somerset — Somerville, New Jersey, United States (enrolling)
• RWJBarnabas Health - Community Medical Center — Toms River, New Jersey, United States (enrolling)

Full record on ClinicalTrials.gov

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