CTRI/2010/091/001135
Active, not recruiting
Phase 2
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.
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Metastatic breast cancerEstrogen receptor, progesterone and HER2-negative disease
- Sponsor
- Roche Products India Pvt Ltd
- Enrollment
- 44
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\* 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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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