Study Evaluating the Safety and Efficacy of Onartuzumab (Metmab) And/Or Bevacizumab in Combination With Paclitaxel in Patients With Metastatic, Triple Negative Breast Cancer
Status: | Completed |
---|---|
Conditions: | Breast Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 6/3/2016 |
Start Date: | March 2011 |
End Date: | March 2016 |
A Randomized, Phase II, Multicenter, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of Onartuzumab (Metmab) And/Or Bevacizumab in Combination With Paclitaxel in Patients With Metastatic, Triple Negative Breast Cancer
This is a randomized, Phase II, double-blind, multicenter, placebo controlled trial designed
to preliminarily estimate the efficacy and evaluate the safety and tolerability of MetMAb +
bevacizumab + paclitaxel and MetMAb + placebo + paclitaxel versus placebo + bevacizumab +
paclitaxel in patients with metastatic or locally recurrent, triple-negative breast cancer
who either have not received treatment (first line) or have progressed after one
conventional cytotoxic chemotherapy regimen (second-line).
to preliminarily estimate the efficacy and evaluate the safety and tolerability of MetMAb +
bevacizumab + paclitaxel and MetMAb + placebo + paclitaxel versus placebo + bevacizumab +
paclitaxel in patients with metastatic or locally recurrent, triple-negative breast cancer
who either have not received treatment (first line) or have progressed after one
conventional cytotoxic chemotherapy regimen (second-line).
Inclusion Criteria:
- Women age >/= 18 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Histologically confirmed ER-, PR-, and HER2-negative (triple-negative) adenocarcinoma
of the breast
- Confirmed availability of tumor tissue
Exclusion Criteria:
- Prior therapy with two or more regimens for metastatic breast cancer
- Any systemic anti-cancer therapy within 3 weeks prior to Day 1 of Cycle 1
- Major surgical procedure, open biopsy, or significant traumatic injury within 30 days
prior to Day 1 of Cycle 1
- Prior therapy with a taxane for metastatic breast cancer
- Prior therapy with bevacizumab, sorafenib, sunitinib, or other putative VEGF
pathway-targeted therapy following diagnosis of breast cancer
- Prior therapy with hormones and/or trastuzumab
- Inadequate hematology, renal, or hepatic organ function
Bevacizumab exclusion criteria
- Uncontrolled hypertension (systolic pressure > 150 mmHg and/or diastolic pressure >
100 mmHg), with or without anti-hypertensive medication
- Evidence of bleeding diathesis or coagulopathy
We found this trial at
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