Locally Advanced Breast Cancer: Individualized Treatment Based On Tumor Molecular Characteristics
Status:
Terminated
Trial end date:
2014-12-02
Target enrollment:
Participant gender:
Summary
Paclitaxel 30 mg/m2 twice/week Trastuzumab 4mg/kg, loading dose, then 2 mg/kg weekly and
Concurrent RT (to start within one week from first dose of Paclitaxel/Trastuzumab) to breast,
supraclavicular, axillary fields, 45 Gy @ 1.8 Gy/fraction, + 14 Gy @ 2 Gy/fraction to the
primary tumor. At the end of chemo-radiation, Trastuzumab will be continued weekly until
surgery and as per standard of care after surgery for up to 1 year total.
**Surgery: Patients will undergo lumpectomy and axillary node dissection or modified radical
mastectomy within two months following discontinuation of pre-operative systemic therapy,
contingent upon recovery of skin toxicity. Pathologic response will be evaluated at the time
of surgery. Additional tissue samples will be collected from the surgical specimen for
assessment of tumor molecular characteristics.
***All patients may undergo four cycles of post-operative Standard AC (doxorubicin 60 mg/m2,
cyclophosphamide 600 mg/m2) or four cycles of post-operative epirubicin and Cyclophosphamide
(epirubicin 100 mg/m2, cyclophosphamide 600 mg/m2) if doxorubicin is not available Tamoxifen
as well or any alternative antihormonal therapy may be prescribed for five years for patients
with hormone receptor positive tumors. Herceptin (Trastuzumab) will be prescribed for a total
of 1 year since first dose as per standard of care.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
New York University School of Medicine NYU Langone Health