HER-2 Positive Breast Cancer Clinical Trial
Official title:
Clinical and Translational Phase II Study of Liposomal Doxorubicin Plus Docetaxel and Trastuzumab With Metformin as Primary Systemic Therapy for Operable and Locally Advanced Recombinant Human ErbB-2 (HER2) Positive Breast Cancer
It is a multicenter, open-label, two stage phase II trial, to assess activity, safety and
potential early predictors of response in neoadjuvant setting. Patients with operable breast
cancer (T1c and cytologically N1-2, or cT2-3, N0-N2, M0) or locally advanced breast cancer
(T4a-d, N0-N2, M0) with overexpression or amplification of HER2 (AJCC 7th edition 2010) are
included in the study.
The primary objective is to evaluate the pathological complete response rate (pCR).
The secondary objectives are:
- to evaluate the clinical response rate (RR).
- to evaluate the feasibility and systemic tolerance, with particular attention to cardiac
toxicity.
- to evaluate the conservative surgery rate.
Total duration of the trial is 36 months; planned treatment are 6 cycles of chemotherapy. At
every cycle (every 21 days) will be administered:
Day 1: Liposome-encapsulated doxorubicin, 50 mg/m2 IV 1 hour infusion; Day 2 and 9:
Docetaxel, 30 mg/m2 IV 1 hour infusion; Day 2, 9 and 16: Trastuzumab 4 mg/kg for the first
infusion loading dose, then 2 mg/kg/week for subsequent injections. Day -13 to 0: Metformin
is administered as single agent. From day -13 to day -11, Metformin 1000 mg will be
administered once a day; from day -10 Metformin 1000 mg will be administered twice a day
continuously until end of the study treatment.
Multi-center, open-label phase II trial to assess activity of this chemotherapy scheme
evaluated by pathologic complete response rate (pCR).
Planned treatment are 6 cycles of chemotherapy.
At every cycle (every 21 days) will be administered:
Day 1: Liposome-encapsulated doxorubicin, 50 mg/m2 IV 1 hour infusion; Day 2 and 9:
Docetaxel, 30 mg/m2 IV 1 hour infusion; Day 2, 9 and 16: Trastuzumab 4 mg/kg for the first
infusion loading dose, then 2 mg/kg/week for subsequent injections Day -13 to 0: Metformin is
administered as single agent. From day -13 to day -11, Metformin 1000 mg will be administered
once a day; from day -10 Metformin 1000 mg will be administered twice a day continuously
until end of the study treatment.
Total duration of the trial: 36 months Enrollment period: 24 months Treatment: maximum of 6
cycles (5 months) per patient Follow-up for recurrence: every six months for 5 years, than
once a year until 10 years after surgery.It's necessary to recruit 46 patients for clinical
objectives evaluation.
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