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Modulation of Response to Hormonal Therapy With Lapatinib and/or Metformin in Patients With Metastatic Breast Cancer

NCT01477060 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2014-02-20

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Lapatinib

1250 mg/ die, os

DRUG

Metformin

1500 mg/die, os

Sponsors & Collaborators

  • Fondazione Michelangelo

    lead OTHER

Principal Investigators

  • Milvia Zambetti, MD · Ospedale San Raffaele

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • Italy

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01477060 on ClinicalTrials.gov