Daily Everolimus in Combination With Trastuzumab and Vinorelbine in HER2/Neu Positive Women With Locally Advanced or Metastatic Breast Cancer (BOLERO-3)
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| ClinicalTrials.gov Identifier: NCT01007942 |
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Recruitment Status :
Completed
First Posted : November 4, 2009
Results First Posted : April 5, 2017
Last Update Posted : April 5, 2017
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Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
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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 |
| Conditions |
HER2/Neu Over-expressing Locally Advanced Breast Cancer Metastatic Breast Cancer |
| Interventions |
Drug: everolimus Drug: Placebo Drug: vinorelbine Drug: trastuzumab |
| Enrollment | 569 |
Participant Flow
| Recruitment Details | DCO ( Data cut-off) for patient disposition is 1-Apr-2015. Each Cycle = 21 days |
| Pre-assignment Details | 284 patients randomized to the Everolimus + trastuzumab + vinorelbine arm, 280 took drug. 285 patients randomized to the placebo + trastuzumab + vinorelbine arm, 282 too drug. A total of 569 were comprised to randomized total and 562 to safety. |
| Arm/Group Title | Everolimus + Vinorelbine + Trastuzumab | Placebo + Vinorelbine + Trastuzumab |
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 Arm/Group Description |
Oral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only) | Oral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only) |
| Period Title: Overall Study | ||
| Started | 284 | 285 |
| Completed | 3 [1] | 7 [1] |
| Not Completed | 281 | 278 |
| Reason Not Completed | ||
| Adverse Event | 29 | 14 |
| Abnormal test procedure | 0 | 1 |
| Disease progression | 217 | 242 |
| New cancer therapy | 5 | 1 |
| Protocol Violation | 1 | 1 |
| Withdrawal by Subject | 19 | 14 |
| Lost to Follow-up | 1 | 0 |
| Administrative problems | 2 | 0 |
| Death | 3 | 2 |
| Patients untreated | 4 | 3 |
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[1]
Pts completed= on treatment at time of DCO. Not Completed = ended treatment as per protocol.
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Baseline Characteristics
| Arm/Group Title | Everolimus + Vinorelbine + Trastuzumab | Placebo + Vinorelbine + Trastuzumab | Total | |
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Arm/Group Description |
Oral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only) | Oral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only) | Total of all reporting groups | |
| Overall Number of Baseline Participants | 284 | 285 | 569 | |
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Baseline Analysis Population Description |
The Full Analysis Set (FAS) consisted of all randomized patients.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 284 participants | 285 participants | 569 participants | |
| 54.3 (10.98) | 53.4 (11.00) | 53.8 (10.99) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 284 participants | 285 participants | 569 participants | |
| Female |
284 100.0%
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285 100.0%
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569 100.0%
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| Male |
0 0.0%
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0 0.0%
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0 0.0%
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Outcome Measures
Adverse Events
Limitations and Caveats
All randomized patients were included in the FAS. Seven patients (4 in the everolimus arm & 3 in the placebo arm) were randomized but never received treatment & were therefore excluded from the Safety Set.
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 terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
Results Point of Contact
| Name/Title: | Study Director |
| Organization: | Novartis Pharmaceuticals |
| Phone: | 862-778-8300 |
| EMail: | trialandresults.registries@novartis.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT01007942 |
| Other Study ID Numbers: |
CRAD001W2301 2008-008697-31 ( EudraCT Number ) |
| First Submitted: | November 2, 2009 |
| First Posted: | November 4, 2009 |
| Results First Submitted: | June 10, 2016 |
| Results First Posted: | April 5, 2017 |
| Last Update Posted: | April 5, 2017 |