Optimize Neoadjuvant Therapy in HER2-Positive Early-Stage Breast Cancer
About this study
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.
- Condition
- HER2-positive Early-stage Breast Cancer
- Tested
- Trastuzumab, Pertuzumab, Docetaxel, Carboplatin
- Sponsor
- Rutgers, The State University of New Jersey
Who can join
- Age
- 18 to 90 years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 24
- Minimum age: 18 years
- Maximum age: 90 years
- Study condition: HER2-positive Early-stage Breast Cancer
- 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
- 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.
Exclusion 14
- 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)
- 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
Where
7 sites, 7 recruiting
RWJBarnabas Health - Trinitas Hospital and Comprehensive Cancer Center
Elizabeth, New Jersey, United States
RWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton
Hamilton, New Jersey, United States
RWJBarnabas Health - Monmouth Medical Center
Long Branch, New Jersey, United States
Rutgers Cancer Institute
New Brunswick, New Jersey, United States
RWJBarnabas Health - Newark Beth Israel Medical Center
Newark, New Jersey, United States
RWJBarnabas Health - Robert Wood Johnson University Hospital, Somerset
Somerville, New Jersey, United States
and 1 more site on ClinicalTrials.gov
Contact
-
Mridula A George
732-235-9692 mridula@cinj.rutgers.edu
Potential match only. Final eligibility is determined by the study team.