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Optimizing Treatment for HER2-Positive Early-Stage Breast Cancer

This study is looking at new ways to treat HER2-positive early-stage breast cancer. It uses a special test called HARPS to help decide the best treatment plan for you. Depending on your HARPS test results, you might receive a combination of targeted therapies like trastuzumab and pertuzumab, and/or chemotherapy drugs such as docetaxel or carboplatin. The study aims to find the most effective treatment while reducing side effects. We are also looking at how these treatments affect your quality of life. To join, you need to be between 18 and 90 years old, have HER2-positive breast cancer with a tumor size greater than 2cm or lymph node involvement, and your ER/PR status must be known. The study plans to enroll 50 participants, but its current status is unclear.

Study design
This is an open-label Phase 2 study, meaning you and your doctors will know which treatments you are receiving. It uses an adaptive design, adjusting treatment based on your tumor's HARPS test results.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored for up to 36 months after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07402473

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

Recruiting
PHASE2Ages 18–90InterventionalTreatment
Rutgers, The State University of New Jersey
~50 participants
Updated 2026-04-23 on ClinicalTrials.gov
What's tested:TrastuzumabPertuzumabDocetaxelCarboplatin

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) Assessed by CTCAE v5.0
Measured over up to 36 months

Conditions

HER2-positive Early-stage Breast Cancer

Explore related trials

Breast Carcinoma

Where it's being run

7 sites across 1 states
New Jersey7

Who to contact

Mridula A George
[email protected]
732-235-9692
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

ANC ≥ 1500/uL
platelet count ≥ 100,000/uL
hemoglobin ≥ 9.0 g/dL 10. Adequate hepatic function:
Total bilirubin ≤ 1.5 X ULN
AST (SGOT) ≤ 5 X ULN
ALT (SGPT) ≤ 5 X ULN 11. Patients with biliary obstruction must have restored biliary flow by placement of an endoscopic common bile duct stent or a percutaneous drainage. 12. Adequate renal function, Creatinine \< 1.5x institutional ULN or calculated creatinine clearance ≥ 50 mL/min as estimated using the Cockcroft-Gault formula. 13. Ability to understand the nature of this study protocol and give written informed consent. 14. Willingness and ability to comply with scheduled visits and treatment plans 15. Prior cancers allowed if no evidence of disease in last 5 years. Prior history of ipsilateral invasive breast cancers are not allowed.

What this trial measures

  • Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) Assessed by CTCAE v5.0up to 36 months

    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.