Optimizing Pre-Surgery Treatment in HER2-Positive Early-Stage Breast Cancer
Sponsor: Rutgers, The State University of New Jersey
ClinicalTrials ID:NCT07402473
This clinical trial is exploring a new approach to improve treatment before surgery for patients with HER2-positive early-stage breast cancer. The study aims to find the best treatment plan by using a special test to guide therapy and monitor changes in cancer DNA and quality of life.
Patient Parameters
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Program Overview
This study is testing a new way to treat HER2-positive early-stage breast cancer before surgery. It uses a special test called HARPS to identify specific types of breast cancer. The goal is to see if this approach can improve survival rates and quality of life by tailoring treatment to each patient's cancer type. Researchers will also look at how changes in cancer DNA relate to treatment outcomes.
Description
The EUREKA study is a Phase II trial focused on improving pre-surgery treatment for patients with stage II-III HER2-positive breast cancer. The trial uses an adaptive design, meaning treatment is adjusted based on how well it works for each patient. Patients will be tested with the HARPS assay to determine if their cancer is HARPS-positive or HARPS-negative.
For HARPS-positive patients, treatment starts with dual HER2-targeted therapy (trastuzumab and pertuzumab) for 3 cycles. If the cancer responds, this continues for 6 cycles. If not, chemotherapy is added for 4 cycles, followed by 2 more cycles of HER2-targeted therapy before surgery.
For HARPS-negative patients with detectable cancer DNA, treatment includes 4 cycles of Taxane, platinum, trastuzumab, and pertuzumab. If cancer DNA clears, they receive 2 more cycles before surgery. If not, treatment is intensified with additional drugs.
The study will include 50 patients, split evenly between HARPS-positive and HARPS-negative groups.
Eligibility Criteria
Inclusion Criteria
- Tumor size over 2 cm or positive lymph nodes.
- Tumors must be HER2-positive.
- Known estrogen and progesterone receptor status.
- Enough tumor sample for HARPS testing.
- Cancer DNA collection before treatment.
- Ability to undergo breast MRI.
- Heart function above 50%.
- No prior anthracycline chemotherapy.
- Adequate blood cell counts and liver function.
- Restored bile flow if needed.
- Good kidney function.
- Ability to understand and consent to the study.
- Willingness to follow study visits and treatments.
- No cancer recurrence in the last 5 years, except certain skin or cervical cancers.
Exclusion Criteria
- Previous treatment for invasive breast cancer, except up to 1 cycle of HP.
- Advanced tumors (cT4 or cN3).
- Evidence of cancer spread.
- Cancer in both breasts.
- Other cancers in the last 5 years, except certain skin or cervical cancers.
- Heart function below 50%.
- Active liver disease.
- Conditions posing high risk according to the investigator.
- Severe nerve damage.
- Significant heart disease or recent heart attack.
- Serious wounds or fractures.
- Uncontrolled infections like HIV or hepatitis.
- Allergies to study drugs.
- Medical or psychiatric conditions preventing study participation.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| RWJBarnabas Health - Trinitas Hospital and Comprehensive Cancer Center | 07202 | Elizabeth | New Jersey |
| RWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton | 08690 | Hamilton | New Jersey |
| RWJBarnabas Health - Monmouth Medical Center | 07740 | Long Branch | New Jersey |
| Rutgers Cancer Institute | 08901 | New Brunswick | New Jersey |
| RWJBarnabas Health - Newark Beth Israel Medical Center | 07112 | Newark | New Jersey |
| RWJBarnabas Health - Robert Wood Johnson University Hospital, Somerset | 08876 | Somerville | New Jersey |
| RWJBarnabas Health - Community Medical Center | 08755 | Toms River | New Jersey |
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