Status:
COMPLETED
A Study of Bevacizumab in Combination With Gemcitabine and Carboplatin in Participants With Triple Negative Metastatic Breast Cancer
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
This multicenter study will assess the efficacy and safety of bevacizumab in combination with gemcitabine and cisplatin as first line treatment in participants with triple negative metastatic breast c...
Eligibility Criteria
Inclusion
- Female participants, \>/= 18 years of age
- Metastatic breast cancer
- Estrogen receptor-, progesterone- and human epidermal growth factor receptor 2 (HER2)-negative disease
- Treatment-naïve for metastatic breast cancer
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Adequate hematological, renal and liver function
- Patients should have received Anthracyclines and Taxanes in the adjuvant setting
- Women of childbearing potential must agree to use adequate contraception (per institutional standard of care) during treatment and until 6 months after the last administration of investigational products
Exclusion
- Prior first line treatment for metastatic breast cancer
- Central nervous system (CNS) metastasis
- Uncontrolled hypertension (\> 170/95 mmHg)
- Evidence of bleeding diathesis, coagulopathy or hemorrhage at baseline
- Other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer.
- Prior therapy with gemcitabine or carboplatin in the metastatic setting. Participants 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
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01201265
Start Date
February 1 2011
End Date
April 1 2015
Last Update
May 27 2016
Active Locations (12)
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1
Ahmedabad, India, 380009
2
Bangalore, India, 560029
3
Bangalore, India, 560054
4
Delhi, India, 110029