Neoadjuvant Dose-Dense For Early Her2Neu Positive Breast Cancer

Stopped early · Phase 2

Conditions studied: Locally Advanced Breast Cancer

In brief

Primary Objective: • Determination of pathologic complete response (pCR) rates Secondary Objective: * Determination of cardiac toxicity as measured by: composite of LVEF, longitudinal strain and troponin. * Breast conservation rates * Overall survival Study Design * Approximately 34-74 patients with Her2 positive, Stage II-regional IV breast cancer will be enrolled. * Patients will be stratified by ER/PR status. * They will be randomized to ddACTHP vs TCHP. * Initially, 17 patients will be randomly assigned to each treatment arm. * If 3 or fewer patients have a pCR, then that arm will be terminated and no further patients will be entered on that treatment arm. * If 4 or more patients obtain a pCR, 20 additional patients (total of 37 patients) will be randomized to that treatment arm. * If 11 or more patients out of 37 have a pCR, the treatment will be of interest for further study.

Key facts

Study ID

NCT03329378

Run by

Icahn School of Medicine at Mount Sinai

People needed

7

Starts

2019-01-24

Expected to finish

2021-03-07

Last updated by the study team

2023-08-22

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mount Sinai Beth Israel — New York, New York, United States
• Mount Sinai West — New York, New York, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States

Full record on ClinicalTrials.gov

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