Actively Recruiting
Optimize Neoadjuvant Therapy in HER2-Positive Early-Stage Breast Cancer
Led by Rutgers, The State University of New Jersey · Updated on 2026-04-23
50
Participants Needed
7
Research Sites
118 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Optimize Neoadjuvant Therapy in HER2-Positive Early-Stage Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Tumor size greater than 2 cm or lymph node positive by imaging or clinical exam (cT2-T3 N0-2)
- Tumors must be HER2 positive by IHC (3+) or IHC 2+ and FISH positive
- Known estrogen receptor (ER) and progesterone receptor (PR) status prior to study entry
- Adequate tumor sample available for HARPS testing
- ctDNA collection prior to treatment on trial
- Ability to undergo breast MRI as determined by the study
- Baseline left ventricular ejection fraction (LVEF) greater than 50% within last 5 years
- No prior systemic treatment with anthracycline-based chemotherapy
- Adequate bone marrow function: ANC ≥ 1500/uL, platelet count ≥ 100,000/uL, hemoglobin ≥ 9.0 g/dL
- Adequate liver function: Total bilirubin ≤ 1.5 X upper limit, AST and ALT ≤ 5 X upper limit
- Biliary obstruction resolved by stent or drainage if present
- Adequate renal function: Creatinine < 1.5x ULN or creatinine clearance ≥ 50 mL/min
- Ability to understand study and provide 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; no prior ipsilateral invasive breast cancer
You will not qualify if you...
- Previous treatment with chemotherapy, anti-HER2 therapy, radiation, or endocrine therapy for invasive breast cancer (except up to 1 cycle of trastuzumab and pertuzumab before study)
- Tumors classified as cT4 and/or cN3
- Evidence of metastatic disease by routine clinical assessment
- Bilateral breast cancer
- Other malignancy within last 5 years except treated basal/squamous cell skin cancer or in situ cervical cancer
- Left ventricular ejection fraction (LVEF) below 50%
- Active liver disease
- Any condition or lab abnormality placing participant at unacceptable risk
- Pre-existing sensory neuropathy greater than grade 1
- Clinically significant cardiac disease or recent myocardial infarction within 6 months
- Serious non-healing wound, ulcer, or bone fracture
- Uncontrolled or active infection with HIV, Hepatitis B, or Hepatitis C
- Allergy or hypersensitivity to study drugs
- Any serious medical, laboratory, or psychiatric condition preventing study participation
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Trial Site Locations
Total: 7 locations
1
RWJBarnabas Health - Trinitas Hospital and Comprehensive Cancer Center
Elizabeth, New Jersey, United States, 07202
Actively Recruiting
2
RWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton
Hamilton, New Jersey, United States, 08690
Actively Recruiting
3
RWJBarnabas Health - Monmouth Medical Center
Long Branch, New Jersey, United States, 07740
Actively Recruiting
4
Rutgers Cancer Institute
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
5
RWJBarnabas Health - Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
Actively Recruiting
6
RWJBarnabas Health - Robert Wood Johnson University Hospital, Somerset
Somerville, New Jersey, United States, 08876
Actively Recruiting
7
RWJBarnabas Health - Community Medical Center
Toms River, New Jersey, United States, 08755
Actively Recruiting
Research Team
M
Mridula A George
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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