HER-2 positive metastatic breast cancer MedDRA version: 14.1 Level: PT Classification code 10055113 Term: Breast cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: HERCEPTIN*EV 1FL 150MG
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Trastuzumab
Concentration unit: mg milligram(s)
Concentration number: 150-
Sponsors
IST - ISTITUTO NAZIONALE PER LA RICERCA SUL CANCRO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Female gender 2. Age > 18 years 3. ECOG Performance Status 0-1 (Appendix II) 4. Histological diagnosis of breast cancer with evidence of metastatic or recurrent disease. Lesions should not be amenable to surgery or radiation for curative intent. 5. Baseline LVEF ≥ 50 measured by echocardiography or MUGA scan 6. Overexpression of HER2 (Appendix IV) 7. Indication to treatment with chemotherapy + Trastuzumab. 8. Previous hormonal therapy for both adjuvant and metastatic disease is allowed. 9. Previous adjuvant and/or neo-adjuvant chemotherapy is allowed 10. Previous Trastuzumab therapy for adjuvant treatment is allowed 10. Estimated life expectancy of at least 12 weeks. 11. Adequate bone marrow, liver and renal function. 12. Signed written informed consent obtained prior to study screening procedures. 13. Patients with reproductive potential must use an approved contraceptive method if appropriate (except hormonal substitutive therapy) during and for 3 months after stopping treatment. Are the trial subjects under 18? no Number of subjects for this age range: 0 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: 1. Past or current history of malignant neoplasms except for curatively treated ones. The following malignant neoplasms if curatively treated, do not preclude patient inclusion: basal and squamous cell carcinoma of the skin, in situ carcinoma of the cervix, any cancer that has been curatively treated, with no evidence of disease, and a 180mm Hg or diastolic greater than 100mm Hg) 6. Pregnant or lactating women 7. Patients with clinical evidence of symptomatic brain metastasis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to compare efficacy in terms of Progression Free Survival (PFS) of Trastuzumab at the maintaining dose of 1 mg/kg/week or 3 mg/kg/q3w vs the standard dose of 2 mg/kg/week or 6 mg/kg/q3w in metastatic breast cancer patients with HER-2 overexpressing tumors and candidates for first line treatment with chemotherapy associated with Trastuzumab;Secondary Objective: to compare a) Overall Survival (OS) b) Overall Response Rate (ORR) c) Toxicity d) Cardiotoxicity (Appendix 2) e) Pharmacokinetic (Appendix 1) between the two study arms;Primary end point(s): Time to progression | — |
Countries
Italy
Outcome results
None listed