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RecruitingPhase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 90 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Treatment response will be monitored by ctDNA and MRI breast."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a treatment plan used before surgery for early-stage HER2-positive breast cancer, which has high levels of a protein called HER2. It uses a tumor test called HARPS to help guide treatment and checks whether treatment clears cancer from the breast and lymph nodes. It also tracks cancer return, cancer DNA in blood, and quality of life.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Your tumor must be larger than 2 centimeters, or cancer must be found in nearby lymph nodes, within the study’s stage limits.
  • Tests must show HER2-positive cancer. Your tumor’s estrogen and progesterone hormone receptor test results must also be known.
  • You must have enough tumor tissue for HARPS testing and give a blood sample for cancer DNA testing before study treatment.
  • You must be able to have a breast MRI scan.
  • Your heart must pump out more than 50% of its blood with each beat, based on a test within the past 5 years.
  • Your blood counts, liver, and kidneys must meet study limits. Any blocked bile duct must have drainage restored.
  • You must not have had anthracyclines, a type of chemotherapy, or invasive breast cancer in the same breast before.
  • You must understand the study, give written consent, and be willing and able to follow the visit and treatment plans.

Who can't join

  • Past chemotherapy, HER2-targeted treatment, radiation, or hormone treatment for invasive breast cancer. Up to one cycle of the HER2 treatment called HP is allowed before study treatment.
  • Cancer in both breasts, cancer that has spread to distant parts of the body, or tumors in the more advanced local stages called cT4 or cN3.
  • Another cancer within the past 5 years, except certain skin cancers or early cervical cancer treated to cure them.
  • Heart pumping below 50%, serious heart disease, poorly controlled heart rhythm problems, or a heart attack within the past 6 months.
  • Active liver disease or an active or uncontrolled infection with HIV, hepatitis B, or hepatitis C.
  • Nerve damage affecting feeling that is more than mild, or a serious wound, sore, or broken bone that is not healing.
  • An allergy to any study drug.
  • Any medical condition, mental health condition, or abnormal lab result that makes joining unsafe or prevents participation.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Inclusion Criteria 1. Tumor size greater than 2cm or lymph node positive by imaging or clinical exam (cT2-T3 N0-2) 2. Tumors must be HER2 positive either by IHC (3+) or by IHC 2+ and FISH positive. 3. Patient must have known estrogen receptor (ER) and progesterone receptor (PR) status locally determined prior to study entry 4. Patient must have adequate tumor for HARPS testing. 5. Patients must have ctDNA collection prior to treatment on trial. 6. Patient must be able to do breast MRI as determined by the study 7. Baseline LVEF \> 50% (Most recent within the last 5 years) 8. No prior history of systemic treatment with anthracyclines-based chemotherapy. 9. Adequate bone marrow function: * 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. Exclusion Criteria: 1. 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. 2. cT4 and/or cN3 tumors 3. Evidence of metastatic disease by routine clinical assessment 4. Bilateral breast cancer 5. 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 6. Left ventricular ejection fraction (LVEF) below 50% as determined by multiple-gated acquisition (MUGA) scan or echocardiography (ECHO) 7. No active liver disease. 8. 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. 9. Pre-existing sensory neuropathy \> grade 1. 10. 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. 11. Serious non-healing wound, ulcer, or bone fracture 12. Patient with uncontrolled and/ or active infection with HIV, Hepatitis B or Hepatitis C. 13. Patient who has a history of allergy or hypersensitivity to any of the study drugs. 14. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study

Study sites (7)

NJ