Metastatic breast cancer in first line treatment, whitout rapidly progressive disease HER2+/ER+ and/or PgR+ (evaluated on the primary or metastatic lesion) MedDRA version: 9.1 Level: LLT Classification code 10055113
Conditions
Interventions
Trade Name: TYVERB
Pharmaceutical Form: Coated tablet
INN or Proposed INN: LAPATINIB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-
Pharmaceutical Form: Coat
Sponsors
AZIENDA OSPEDALIERA POLICLINICO DI MODENA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Metastatic breast cancer in first line treatment, whitout rapidly progressive disease HER2+/ER+ and/or PgR+ (evaluated on the primary or metastatic lesion) Previous (neo)adjuvant therapy with Trastuzumab and chemotherapy (with anthracycline and/or taxanes), and hormonal therapy Evaluable and/or measurable disease Menopausal status (defined as at least 1 year from the last mense, or less if FSH and E2 levels indicate menopause) Normal organ and marrow functions ECOG PS 0-1 LVEF within the institutional range of normal Ability to swallow and retain oral medication Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Rapidly progressive disease, defined as relapse within 6 months from initial diagnosis, or life-threatining disease, or extensive visceral involvement, or life expectancy 3000/mcL, absolute neutrophil count >1,500/mcL, platelets >100,000/mcL, total bilirubin within normal institutional limits, AST (SGOT)/ALT(SGPT) <1.5 X institutional upper limit of normal, Creatinine within normal institutional limits Concomitant CYP3A4 inducers or inhibitors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - The time to progression 1 (TTP1) (as interval between randomization and first progression of the disease – PD1);Secondary Objective: - The time to progression 2 (TTP2) (as interval between randomization and the progression of the disease after the crossover, study withdrawal or death for any cause – PD2) - The Response Rate (according to RECIST criteria) - The clinical benefit rate - The Quality of life - The overall survival (OS) - The side effects of the treatments;Primary end point(s): - Time to progression 1 (TTP1): the interval between the randomization and the first appearance of disease progression, study withdrawal or death for any cause - Time to progression 2 (TTP2): the interval between randomization and the progression after the cross-over, study withdrawal or death for any cause - Response Rate (RECISTv1.1 2009) - The Quality of life, with QLQ30-BR - Overall survival (OS): the interval between randomization and death for any cause - Side effects of the treatments, coording to CTC v3.0 | — |
Countries
Italy
Outcome results
None listed