Human Epidermal Growth Factor 2 Negative Carcinoma of Breast Clinical Trial
Official title:
Phase II Comparative Study of Myocet Plus Cyclophosphamide in First Line Treatment of HER2 Negative Metastatic Breast Patients
This is a phase II comparative randomized clinical trial.
Eligible patients will be randomized (1:1) to:
Arm A: Myocet plus Cyclofosfamide plus Metformin Arm B: Myocet plus Cyclofosfamide
Statistical Considerations:
In this randomized phase II study, the sample size was calculated basing on the primary
end-point (PFS) and assuming an error α = 10% (2-tailed) with a power of 80%.
To find an advantage of 4 months of median time to progression (6 months in the control arm
B and 10 months in the experimental arm A) will be recruited 112 patients (98 events) for a
period of 24 months and will be considered further 12-month of follow-up. The primary
analysis of the study will be conducted in accordance with the "intention to treat"
principle, the secondary analysis will be conducted in the "per protocol" population.
MULTICENTER, RANDOMIZED, COMPARATIVE STUDY OF MYOCET PLUS CYCLOPHOSPHAMIDE PLUS METFORMIN
VERSUS MYOCET PLUS CYCLOPHOSPHAMIDE IN FIRST LINE TREATMENT OF HER2 NEGATIVE METASTATIC
BREAST CANCER PATIENTS.
The aim of this study is to determine if the addition of metformin to the regime Myocet /
Cyclophosphamide improves disease-free survival in patients with HER2-negative metastatic
breast cancer.
The primary objective is the evaluation of the clinical efficacy of the combination of
Myocet / Cyclophosphamide plus Metformin compared to treatment with only Myocet /
Cyclophosphamide, in terms of progression-free survival (PFS).
Clinical secondary objectives are:
- Objective response rate
- Overall survival
- Tolerability
- Progression-free survival, objective response rate and overall survival according to
Homa Index levels.
Secondary biological endpoint is the characterization of the metabolic profile of patients
(sensitivity in insulin levels).
Treatment Arm A (experimental treatment):
Metformin 1000 mg, 2 times daily per os*. Myocet 60 mg/m2, intravenous infusion, on day 1,
every 21 days Cyclophosphamide 600 mg/m2, intravenous infusion, at day 1 every 21 days.
* During cycle 1, patients will assume only metformin from day 1 to day 13 and will begin
chemotherapy from day 14. From day 1 to day 3, patients will assume Metformin 1000 mg once a
day. Starting from day 4 patients will assume Metformin 1000 mg 2 times a day.
Arm B (standard treatment):
Myocet 60 mg/m2, intravenous infusion, on day 1, every 21 days Cyclophosphamide 600 mg/m2,
intravenous infusion, on day 1, every 21 days
Chemotherapy will be performed for 8 cycles.
The treatment will be continued until progression of disease.
Statistical Considerations:
In this randomized phase II study, the sample size was calculated basing on the primary
end-point (PFS) and assuming an error α = 10% (2-tailed) with a power of 80%.
To find an advantage of 4 months of median time to progression (6 months in the control arm
B and 10 months in the experimental arm A) will be recruited 112 patients (98 events) for a
period of 24 months and will be considered further 12-month of follow-up. The primary
analysis of the study will be conducted in accordance with the "intention to treat"
principle, the secondary analysis will be conducted in the "per protocol" population.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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