Status:
TERMINATED
Neoadjuvant Dose-Dense For Early Her2Neu Positive Breast Cancer
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Conditions:
Locally Advanced Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
Primary Objective: • Determination of pathologic complete response (pCR) rates Secondary Objective: * Determination of cardiac toxicity as measured by: composite of LVEF, longitudinal strain and tr...
Eligibility Criteria
Inclusion
- The patient must have signed and dated an IRB-approved consent form that conforms to federal and institutional guidelines.
- Female
- 18 years or older
- ECOG performance status of 0 or 1
- Eligible tumors must meet one of the following criteria:
- Operable (T1c, T2-3, N0-1, M0)
- Locally advanced (T2-3, N2-3, M0 or T4a-c, any N, M0)
- Inflammatory breast cancer (T4d, any N, M0)
- Staging evaluation:
- History and physical exam, cbc, chemistry profile
- CT Chest/Abdomen/Pelvis and a bone scan or PET/CT as needed
- Diagnosis of invasive adenocarcinoma made by core needle biopsy
- Breast cancer determined to be:
- Confirmed HER2-positive : (ASCO CAP guidelines, 10/7/2013)
- IHC 3+ based on circumferential membrane staining that is complete, intense
- ISH positive based on:
- Single probe average HER2 copy number ≥ 6 signals/cell
- Dual probe HER2/CEP 17 ratio ≥ 2.0 with an average HER2 copy number ≥ 4.0 signals/cell
- Dual probe HER2/CEP 17 ratio ≥ 2.0, with an average HER2 copy number of \< 4.0 signals/cell
- Dual probe HER2/CEP 17 ratio \< 2.0 with the average HER2 copy number of ≥ 6.0 signals/cell
- any ER or PR receptor status
- LVEF assessment by echocardiogram within 30 days of initiation; EF of ≥ 55% considered normal.
- Normal troponin I level at baseline
- Blood counts must meet the following criteria:
- ANC greater than or equal to 1500/mm3
- Platelet count greater than or equal to 100,000/mm3
- Hemoglobin greater than or equal to 10 g/dL
- Serum creatinine less than or equal 2.5 mg/100ml
- Adequate hepatic function by these criteria: total bilirubin must be less than or equal to 1.5 x the ULN for the lab unless the patient has a bilirubin elevation great than the ULN to 1.5 x ULN due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin; and alkaline phosphatase must be less than or equal to 2.5 x ULN for the lab; and AST must be less than or equal to 1.5 x ULN for the lab. Both alkaline phosphatase and AST may not both be greater than the ULN.
- Patients with AST or alkaline phosphatase \> ULN are eligible for inclusion in the study if liver imaging (CT, MRI, PET-CT or PET scan) performed within 90 days prior to randomization does not demonstrate metastatic disease and the requirements are met as above
- Patients with alkaline phosphatase that is \> ULN but less than or equal to 2.5 x ULN or unexplained bone pain are eligible for inclusion in the study if a bone scan, PET-CT scan, or PET scan performed within 90 days prior to randomization does not demonstrate metastatic disease.
Exclusion
- Patients with a history of decompensated congestive heart failure or an EF \< 55% will be excluded
- • Cardiac disease that would preclude the use of the drugs included in the above regimens. This includes but is not confined to:
- Active cardiac disease:
- angina pectoris requiring the use of anti-anginal medication;
- ventricular arrhythmias except for benign premature ventricular contractions controlled by medication;
- conduction abnormality requiring a pacemaker;
- supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication; and
- clinically significant valvular disease
- symptomatic pericarditis
- pulmonary hypertension
- History of cardiac disease:
- myocardial infarction;
- congestive heart failure; or
- cardiomyopathy
Key Trial Info
Start Date :
January 24 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 7 2021
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT03329378
Start Date
January 24 2019
End Date
March 7 2021
Last Update
August 22 2023
Active Locations (3)
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1
Mount Sinai Beth Israel
New York, New York, United States, 10011
2
Mount Sinai West
New York, New York, United States, 10019
3
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029