HER2-positive Early-stage Breast CancerPhase 2EUREKANCT07402473
Optimize Neoadjuvant Therapy in HER2-Positive Early-Stage Breast Cancer
A Phase 2 study testing Trastuzumab, Pertuzumab and Docetaxel in people with HER2-positive Early-stage Breast Cancer, run by Rutgers, The State University of New Jersey at 7 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- HER2-positive Early-stage Breast Cancer
- What is being tested?
- Trastuzumab, Pertuzumab and Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 7 sitesUnited States
- Study dates
- 26 Mar 2026to 30 Jun 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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)
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- 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
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
RWJBarnabas Health - Trinitas Hospital and Comprehensive Cancer Center
Elizabeth, New Jersey, 07202
Mridula George, MD, 7322359692, mridula@.rutgers.edu
- Recruiting
RWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton
Hamilton, New Jersey, 08690
Mridula George, MD, 7322359692, mridula@.rutgers.edu
- Recruiting
RWJBarnabas Health - Monmouth Medical Center
Long Branch, New Jersey, 07740
Mridula George, MD, 732-235-9692, mridula@rutgers.edu
- Recruiting
Rutgers Cancer Institute
New Brunswick, New Jersey, 08901
Mridula A George, MD, 732-235-9081, mridula@rutgers.edu
- Recruiting
RWJBarnabas Health - Newark Beth Israel Medical Center
Newark, New Jersey, 07112
Mridula George, MD, 7322359692, mridula@.rutgers.edu
- Recruiting
RWJBarnabas Health - Robert Wood Johnson University Hospital, Somerset
Somerville, New Jersey, 08876
Mridula George, MD, 7322359692, mridula@.rutgers.edu
- Recruiting
RWJBarnabas Health - Community Medical Center
Toms River, New Jersey, 08755
Mridula George, MD, 732-235-9692, mridula@rutgers.edu
About this study
Official title: EUREKA Study: Phase 2 Study to Optimize Neoadjuvant Therapy in HER2-positive Early-stage Breast Cancer Using ctDNA and HARPS Biomarker Assay
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.
Read more
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.
Read the detailed description
EUREKA is a phase II study that will evaluate optimization of neoadjuvant therapy in patients with stage II-III HER2-positive breast cancer. This adaptive clinical trial will enroll patients with cT2-T3 N0-2 HER2-positive breast cancer. Tumors will undergo testing using HARPS assay to identify HARPS-positive and HARPS negative HER2-positive breast cancers.
Patients with HARPS-positive HER2-positive breast cancer will be treated using an adaptive trial design to optimize neoadjuvant therapy such we are maximizing treatment efficacy while reducing risk of treatment related toxicities. Patient will be treated with dual HER2-targeted therapy (trastuzumab and pertuzumab) for 3 cycles. Treatment response will be monitored by ctDNA and MRI breast. If there is treatment response, patients will be treated with 6 cycles of trastuzumab and pertuzumab. If there is no treatment response after 6 weeks, then patients will be treated with the addition of single agent chemotherapy (docetaxel/paclitaxel/Abraxane) with trastuzumab/pertuzumab for 4 cycles followed by 2 cycles of trastuzumab and pertuzumab. Then patients will proceed with breast surgery.
Patients with HARPS-negative HER2-positive breast cancer and detectable ctDNA at time of diagnosis will be treated with 4 cycles of Taxane, platinum, trastuzumab and pertuzumab, and they will be monitored with ctDNA for ctDNA clearance. Patients who have ctDNA clearance will be treated with additional 2 cycles of the same regimen and then proceed to have surgery. If patients have detectable ctDNA at 12 weeks, then neoadjuvant therapy will be escalated to add anthracycline based regimen or trastuzumab deruxtecan (T-DXD) pe treating physicians choice.
The study will enroll a total of 50 patients- 25 patients with HARPS-positive HER2-positive early-stage breast cancer and 25 patients with HARPS-negative HARPS-positive early-stage breast cancer.
- Conditions
- HER2-positive Early-stage Breast Cancer
- Being tested
- Trastuzumab, Pertuzumab, Docetaxel, Carboplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrastuzumabDrug
Trastuzumab is a targeted antibody therapy used to treat HER2-positive breast and stomach cancers by blocking the growth-stimulating HER2 protein
PertuzumabDrug
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
DocetaxelDrug
will be used with HARPS Negative: intravenous chemotherapy medication used to treat breast, lung, prostate, gastric, and head/neck cancers
CarboplatinDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Trastuzumab; Drug: Pertuzumab; Drug: Docetaxel; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start26 Mar 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Early-stage Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mridula George, MD, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07402473
- Sponsor's protocol ID
- 042507
- Other IDs
- Pro2025002581
- Acronym
- EUREKA
- Status last verified
- Apr 2026
- First submitted
- 4 Feb 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No