Study To Evaluate the Efficacy and Safety Of Bevacizumab, and Associated Biomarkers, In Combination With Paclitaxel Compared With Paclitaxel Plus Placebo as First-line Treatment Of Patients With Her2-Negative Metastatic Breast Cancer
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ClinicalTrials.gov Identifier: NCT01663727 |
Recruitment Status :
Completed
First Posted : August 13, 2012
Results First Posted : February 10, 2016
Last Update Posted : January 22, 2019
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Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
Condition |
Metastatic Breast Cancer |
Interventions |
Drug: Bevacizumab [Avastin] Drug: Paclitaxel Drug: Placebo |
Enrollment | 481 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Paclitaxel+Placebo | Paclitaxel+ Bevacizumab |
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Arm/Group Description | Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death. | Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death. |
Period Title: Overall Study | ||
Started | 242 | 239 |
Completed | 0 | 1 |
Not Completed | 242 | 238 |
Reason Not Completed | ||
Death | 161 | 155 |
Lost to Follow-up | 10 | 8 |
Withdrawal by Subject | 18 | 25 |
Study Terminated | 51 | 50 |
Withdrawal by subject and Adverse Event. | 1 | 0 |
Withdrawal prior to dosing. | 1 | 0 |
Baseline Characteristics
Arm/Group Title | Paclitaxel+Placebo | Paclitaxel+ Bevacizumab | Total | |
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Arm/Group Description | Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death. | Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death. | Total of all reporting groups | |
Overall Number of Baseline Participants | 242 | 239 | 481 | |
Baseline Analysis Population Description |
Intent-to-treat (ITT) population: All participants randomized to study treatment irrespective of whether the assigned treatment was actually received.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 242 participants | 239 participants | 481 participants | |
54.7 (10.7) | 55.8 (11.5) | 55.3 (11.1) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 242 participants | 239 participants | 481 participants | |
Female |
237 97.9%
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236 98.7%
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473 98.3%
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Male |
5 2.1%
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3 1.3%
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8 1.7%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Name/Title: | Medical Communications |
Organization: | Hoffmann-LaRoche |
Phone: | 800 821-8590 |
EMail: | genentech@druginfo.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT01663727 |
Other Study ID Numbers: |
GO25632 2011-005335-97 ( EudraCT Number ) |
First Submitted: | August 9, 2012 |
First Posted: | August 13, 2012 |
Results First Submitted: | January 12, 2016 |
Results First Posted: | February 10, 2016 |
Last Update Posted: | January 22, 2019 |