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

Genentech, Inc.185 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

185

Conditions

Breast Cancer

Interventions

Onartuzumab

Onartuzumab will be administered as intravenous (IV) infusion at a dose of 10 milligrams per kilogram (mg/kg) on Day 1 and Day 15 of each 28-day cycle. The dose of onartuzumab will be based on the participant's weight at screening and will remain the same throughout the study.

BevacizumabDRUG

Bevacizumab will be administered as IV infusion at a dose of 10 mg/kg on Day 1 and Day 15 of each 28-day cycle. The dose of bevacizumab will be based on the participant's weight at screening and will remain the same throughout the study.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (53)

Comprehensive Blood/Cancer Ctr

Bakersfield, California, United States

St. Jude Heritage Healthcare; Virgiia K.Crosson Can Ctr

Fullerton, California, United States

Can Care Assoc Med Group Inc; Beach Cities Offices

Los Angeles, California, United States

Univ of California Los Angeles

Los Angeles, California, United States

Kaiser Permanente Sacramento Medical Center

Sacramento, California, United States

Outcomes

Primary Outcomes

Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in Participants Who Have not Received Prior Systemic Therapy or Have Progressed to Prior First-line Treatment

Time frame: From randomization until disease progression (PD), relapse, or death on study (within 30 days of last study drug administration) from any cause, whichever occurs first (to be assessed according to local standard of care overall up to 5 years)

Secondary Outcomes

PFS According to RECIST v1.1 in Participants Who Have not Received Prior Systemic Therapy

Time frame: From randomization until PD, relapse, or death on study from any cause, whichever occurs first (to be assessed according to local standard of care overall up to 5 years)

Percentage of Participants With Objective Response as Assessed by the Investigator According to RECIST v1.1

Time frame: From randomization until PD, relapse, or death on study from any cause, whichever occurs first (to be assessed according to local standard of care overall up to 5 years)

Duration of Response as Assessed by the Investigator Using RECIST v1.1

Time frame: From initial objective response to PD or death on study from any cause, whichever occurs first (to be assessed according to local standard of care overall up to 5 years)

Overall Survival (OS)

Time frame: From randomization until death from any cause, loss to follow-up, study termination by sponsor, or participant's withdrawal in survival follow-up (overall up to 5 years)

Percentage of Participants With Adverse Events (AE) and Serious Adverse Events (SAEs)

Time frame: Day 1 Cycle 1 (cycle length=28 days) up to 30 days after last dose of study drug or study discontinuation/termination, whichever is later (overall up to 5 years)

Number of Cycles of Treatment Received for Onartuzumab, Paclitaxel, and Bevacizumab During the Study

Time frame: Day 1 Cycle 1 (cycle length=28 days) up to last dose of study drug or study discontinuation/termination, whichever is later (overall up to 5 years)

Percentage of Participants With Anti-therapeutic Antibodies (ATAs) Against Onartuzumab

Time frame: Predose on Day 1 of Cycles 1-4 (cycle length=28 days), 30 days after last administration of onartuzumab or initiation of another therapy (overall up to 5 years)

Serum Levels of ATAs Against Onartuzumab

Time frame: Predose on Day 1 of Cycles 1-4 (cycle length=28 days), 30 days after last administration of onartuzumab or initiation of another therapy (overall up to 5 years)