A Multi Centre, Pilot Phase II Trial Assessing The Efficacy And Safety Of Bevacizumab + Gemcitabine + Carboplatin As First Line Treatment For Patients Diagnosed With Triple Negative Metastatic Breast Cancer.
- Conditions
- Health Condition 1: null- Metastatic breast cancerEstrogen receptor, progesterone and HER2-negative disease
- Registration Number
- CTRI/2010/091/001135
- Lead Sponsor
- Roche Products India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 44
* Female patients, >/= 18 years of age
* Metastatic breast cancer
* Estrogen receptor- , progesterone- and HER2-negative disease
* Treatment-naïve for metastatic breast cancer
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Adequate hematological, renal and liver function
Prior first line treatment for metastatic breast cancer
CNS metastasis
Uncontrolled hypertension ( 170/95 mmHg)
Evidence of bleeding diathesis, coagulopathy or hemorrhage at baseline
History of other malignant disease within past 3 years, except for curatively treated basal cell carcinoma of the skin and carcinoma in situ of the cervix
Prior therapy with gemcitabine or carboplatin in the metastatic setting. Patients having received gemcitabine or carboplatin as part of adjuvant therapy are eligible, if recurrence was first documented 6 months after the last exposure to the drug(s)
Requirement of chronic use of immunosuppressive agents
HIV, hepatitis B or hepatitis C infection
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival (PFS), according to RECIST criteria, assessments by CT/MRI/bone scans and X-rayTimepoint: [ Time Frame: approximately 3 years ]
- Secondary Outcome Measures
Name Time Method Clinical benefit response (CBR)Timepoint: [ Time Frame: approximately 3 years ];Hemodynamic measurements: brachial blood pressure, heart rateTimepoint: [ Time Frame: approximately 3 years ];Overall Response Rate (ORR), according to RECIST criteria, assessed by CT/MRI/bone scan and XrayTimepoint: [ Time Frame: approximately 3 years ];Overall Survival (OS)Timepoint: [ Time Frame: approximately 3 years ];Quality of Life: European Organisation for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-30)Timepoint: [ Time Frame: approximately 3 years ];Safety and tolerability: Adverse eventsTimepoint: [ Time Frame: approximately 3 years ];Time to Progression (TTP)Timepoint: [ Time Frame: approximately 3 years ]