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

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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).


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
32
sites
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San Diego, CA
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Bakersfield, CA
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Boston, MA
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Bruxelles,
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Charleston, South Carolina 29412
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Chattanooga, TN
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Durham, NC
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East Setauket, NY
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San Luis Obispo, California 93405
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