Study Evaluating the Safety and Efficacy of Onartuzumab And/or Bevacizumab in Combination With Paclitaxel in Participants With Metastatic, Triple Negative Breast Cancer

Genentech

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Onartuzumab; Drug: Paclitaxel; Drug: Bevacizumab; Drug: Bevacizumab Placebo; Drug: Onartuzumab Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01186991

OAM4861g

2010-020101-32 (EudraCT Number)

GO01334 (Other Identifier)

Details and patient eligibility

About

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 onartuzumab (MetMAb) + bevacizumab + paclitaxel and onartuzumab + placebo + paclitaxel versus placebo + bevacizumab + paclitaxel in participants 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).

Enrollment: 185 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
• Histologically confirmed estrogen receptor (ER)-, progesterone receptor (PR)-, and human epidermal growth factor 2 (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 vascular endothelial growth factor (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 greater than [>] 150 millimeters of mercury [mmHg] and/or diastolic pressure > 100 mmHg), with or without anti-hypertensive medication
• Evidence of bleeding diathesis or coagulopathy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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185 participants in 3 patient groups

Onartuzumab + Bevacizumab + Paclitaxel

Experimental group

Description:

Participants will receive treatment with onartuzumab, bevacizumab, and paclitaxel, which may continue until disease progression, unacceptable drug-related toxicity, investigator decision, death, or completion of study, whichever occurs first (up to approximately 5 years).

Treatment:

Drug: Bevacizumab

Drug: Onartuzumab

Drug: Paclitaxel

Onartuzumab + Placebo + Paclitaxel

Experimental group

Description:

Participants will receive treatment with onartuzumab, placebo matching to bevacizumab, and paclitaxel, which may continue until disease progression, unacceptable toxicity, investigator decision, death, or completion of study, whichever occurs first (up to approximately 5 years).

Treatment:

Drug: Bevacizumab Placebo

Drug: Onartuzumab

Drug: Paclitaxel

Placebo + Bevacizumab + Paclitaxel

Active Comparator group

Description:

Participants will receive treatment with placebo matching to onartuzumab, bevacizumab, and paclitaxel, which may continue until disease progression, unacceptable toxicity, investigator decision, death, or completion of study, whichever occurs first (up to approximately 5 years).

Treatment:

Drug: Bevacizumab

Drug: Paclitaxel

Drug: Onartuzumab Placebo