Neoadjuvant Dose-Dense For Early Her2Neu Positive Breast Cancer



Status:Recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:January 30, 2019
End Date:October 16, 2019
Contact:Neha Kumarley
Email:neha.kumarley@mssm.edu
Phone:212-824-7659

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A Phase II Randomized Trial Evaluating Neoadjuvant Dose-Dense Doxorubicin/Cyclophosphamide Followed by Paclitaxel/Trastuzumab/Pertuzumab (AC THP) and Docetaxel/Carboplatin/Trastuzumab/Pertuzumab (TCHP) For Early Her2Neu Positive Breast Cancer

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.


Inclusion Criteria:

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 Criteria:

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
We found this trial at
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New York, New York 10025
Principal Investigator: Anupama Goel, MD
Phone: 212-523-7289
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New York, New York 10003
Principal Investigator: Paula Klein, MD
Phone: 212-604-6021
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1428 Madison Ave
New York, New York 10029
(212) 241-6500
Principal Investigator: Aarti Bhardwaj, MD
Phone: 212-824-7659
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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