Paclitaxel + Bevacizumab versus doxorubicina liposomiale non pegilata (Myocet), cyclophosfamide e Bevacizumab as the first line treatment in HER-2 negative metastatic breast cancer. Multicenter randomized Study of phase II
- Conditions
- metastatic breast cancer HER2 negativeMedDRA version: 14.1Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-006176-39-IT
- Lead Sponsor
- GOIM GRUPPO ONCOLOGICO MERIDIONALE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria
breast cancer HEr2 negative istologically confirmed
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 70
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Bone metastasis as unic site of desease
Previous chemotherapy for metastatic desease or concomitant therapy with hormonal agents or byotherapy
Sintomatic cerebral metastasis
Hipertension non controlled
Psychic desease
Cardiac desease, ictus,transient ischemic attack, TIA
SNC desease
Ipersensibility to bevacizumab or to agents of protocol
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: to value the activity of chemotherapic combinations in terms of objective response rate;Secondary Objective: To value the quality of life, the tossicity of treatment (in particular the cardiotossity), the time to progression and the overall survival;Primary end point(s): to value the activity of chemotherapic combinations in terms of objective response rate;Timepoint(s) of evaluation of this end point: With an accettable tass of response non inferior to 62%, with a level of significativity of 5% and with a potency of 90%, 21 objective responses will be needed in the first 34 patients to consider active the combination of braccio B therapy.<br>into second phase 36 patients will be needed.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): To value the quality of life, the tossicity of treatment (in particular the cardiotossity), the time to progression and the overall survival;Timepoint(s) of evaluation of this end point: the time of response, the time to progression and the overall survival will be calculated with Kaplan-Meier's method