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

NCT07402473 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 042507Pro2025002581
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

HER2-positive Early-stage Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) Assessed by CTCAE v5.0

  The HARPS assay will be used to identify patients with HARPS positive and HARPS-negative HER2-positive breast cancer. Patients with Stage I-III who meet the specified eligibility criteria would be enrolled in the adaptive clinical trial. The study aims to understand whether the HARPS assay can help optimize the treatment regimen for patients diagnosed with HER2 positive breast cancer. The study will evaluate the pCR rates in patients treated with the adaptive trial regimen. The hypothesis of the study is that the adaptive treatment regimen will help improve pCR rates in patients diagnosed HER2-positive breast cancer based on the HARPS status of the tumor.

  up to 36 months

Study Arms (1)

HARPS POSITIVE COHORT

EXPERIMENTAL

Arm A HARPS POSITIVE COHORT PART A: Patients with HARPS positive HER2 positive breast cancer will be treated with trastuzumab and pertuzumab for three cycles. PART B: Patients who have adequate treatment response after 3 cycles, continue trastuzumab and pertuzumab every 3 weeks for a minimum of 8 cycles in the neoadjuvant setting ARM B: HARPS-NEGATIVE COHORT Patients with HARPS negative tumors must have baseline detectable ctDNA. If patients do not have detectable ctDNA, they will be taken off study. These patients will be replaced.

Drug: Trastuzumab; Drug: Pertuzumab; Drug: Docetaxel; Drug: Carboplatin

Interventions

Trastuzumab DRUG

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

HARPS POSITIVE COHORT

Pertuzumab DRUG

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

HARPS POSITIVE COHORT

Docetaxel DRUG

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

HARPS POSITIVE COHORT

Carboplatin DRUG

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

HARPS POSITIVE COHORT

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (7)

RWJBarnabas Health - Trinitas Hospital and Comprehensive Cancer Center

Elizabeth, New Jersey, 07202, United States

RECRUITING

RWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton

Hamilton, New Jersey, 08690, United States

RECRUITING

RWJBarnabas Health - Monmouth Medical Center

Long Branch, New Jersey, 07740, United States

RECRUITING

Rutgers Cancer Institute

New Brunswick, New Jersey, 08901, United States

RECRUITING

RWJBarnabas Health - Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

RECRUITING

RWJBarnabas Health - Robert Wood Johnson University Hospital, Somerset

Somerville, New Jersey, 08876, United States

RECRUITING

RWJBarnabas Health - Community Medical Center

Toms River, New Jersey, 08755, United States

RECRUITING

MeSH Terms

Interventions

Trastuzumab; pertuzumab; Docetaxel; Carboplatin

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Central Study Contacts

Mridula A George

CONTACT

732-235-9692; mridula@cinj.rutgers.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Program Director, Breast

Model Details: The study is a single arm phase 2 study, which will evaluate optimization of neoadjuvant chemotherapy in patients with stage II-III HER2-positive breast cancer. Tumors will undergo testing using HARPS assay to identify HARPS-positive HER2-positive breast cancers. Patients will also have ctDNA monitored to identify patients that are at increased risk of recurrence.

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 11, 2026
• Study Start: March 26, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

US (7)