Stopped: The study was stopped due to insufficient accrual
Target Population: female patients with HER2-negative, ER and/or PgR positive breast cancer in progression after first-line hormonal therapy. The study rationale is based on the potentiality of reversing endocrine-resistance by Lapatinib * Activity on compensatory-adaptive mechanisms of hyperactivity of signals generated by HER2 family * Modulation of energy balance and signals associated to survival through AMPK activation (via Calmodulin) Metformin * Indirect mechanism, through reduced insulin receptors and IGFR stimulation, with reduces proliferative effects downstream * Direct mechanism, through AMPK activation (via LKB1), with reduced protein synthesis (mTOR inhibition) and increased availability of intracellular energy Lapatinib and Metformin * AMPK "Double"activation, through different potentially additional mechanisms. * Inhibition of proliferative mechanisms for interference on various intracellular target * IR (A e/o B); IGFR * EGFR; HER2 Primary objectives : 1\. To assess the rate of patients free from disease progression at 3 months from randomization Secondary objectives : 1. To assess the overall response rate 2. To assess the duration of response 3. To assess 3-years overall survival rate 4. To assess tolerability of each proposed treatment Female patients with HER2-negative, ER and/or PgR positive breast cancer in progression after first-line hormonal therapy will randomized to receive: hormonal therapy + lapatinib or hormonal therapy + metformin or hormonal therapy + metformin + lapatinib with a ratio 1:1:1. For each arm of the study the following sample size is required: * First step: 23 patients, for a total of 69 patients in all 3 arms * Second step: further 33 patients, for a total of 168 patients in all 3 arms.
Age range
18 Years
Sex
FEMALE
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Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Rate of patients free from disease progression
Timeframe: 3 months from randomization