advanced breast cancer MedDRA version: 9.1 Level: PT Classification code 10057654 Term: Breast cancer female
Conditions
Interventions
Trade Name: HERCEPTIN*EV 1FL 150MG
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: Trastuzumab
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Sponsors
ISTITUTO EUROPEO DI ONCOLOGIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with Metastatic breast cancer (MBC) are considerate eligible. - For the evaluation of concordance between the primary tumour and CTCs, we will be considered eligible patients with MBC, untreated for metastatic disease, with HER-2/neu overexpressed or not on primary tumour, before to start any treatment. - For the evaluation of acquisition of HER-2/neu overexpression, will be considered eligible patients with MBC and HER-2/neu negative on primary tumour, pre-treated with at least one line of chemotherapy. Patients evaluated in the first part of the study, with HER-2/neu negative on primary tumour evaluation and on CTCs, will be valuable for the second part of the study. - For the evaluation of efficacy of trastuzumab-based therapy, will be considered eligible those patients with HER-2/neu absent on primary tumour, that acquired HER-2/neu overexpression on CTCs 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: - Any psychiatric disorder that would impair the understanding and giving of informed consent. - Male patients. - Non evaluable lesions - Pregnant or lactating patients. - History of atrial ventricular arrhythmia, congestive heart failure or angina pectoris, even if medically controlled; uncontrolled hypertension; history of 2nd or 3rd degree heart blocks. - Any history of a second neoplasm except for curatively treated non melanoma skin cancer or carcinoma in situ of the cervix. - Concomitant treatment with other anticancer drugs or other experimental drug. - Patients with not adequate haematological, hepatic and renal function - other serious illness or medical condition
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the acquisition of the HER2/neu overexpression on CTC in patients with advanced breast cancer;Secondary Objective: To evaluate then correlation of acquisition of HER-2/neu overexpression on CTCs and clinical outcome;Primary end point(s): prevalence of patients with the same HER-2/neu expression between the primary tumour and CTCs, and acquisition of HER-2 overexpression. | — |
Countries
Italy
Outcome results
None listed