Phase III Study of BKM120/Placebo With Fulvestrant in Postmenopausal Patients With Hormone Receptor Positive HER2-negative Locally Advanced or Metastatic Breast Cancer Refractory to Aromatase Inhibitor (BELLE-2)
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| ClinicalTrials.gov Identifier: NCT01610284 |
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Recruitment Status :
Completed
First Posted : June 4, 2012
Results First Posted : June 18, 2020
Last Update Posted : August 25, 2020
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Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
| Condition |
Breast Cancer |
| Interventions |
Drug: Fulvestrant Drug: BKM120 Drug: BKM120 matching placebo |
| Enrollment | 1147 |
Participant Flow
| Recruitment Details | This study was conducted at 274 centers in 29 countries worldwide (Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, France, Germany, Greece, Hungary, Israel, Italy, Japan, Republic of Korea, The Netherlands, Peru, Poland, Russia, Singapore, Slovakia, South Africa, Spain, Switzerland, Taiwan, Thailand, UK and USA.). |
| Pre-assignment Details | Approximately 1200 patients were planned to be enrolled in the study. A total of 1147 patients were randomized and analyzed (576 in the buparlisib + fulvestrant and 571 in the placebo + fulvestrant arm). Not completed: in Randomization Phase=Randomized and not Treated; in Treatment Phase=Discontinued study treatment per Protocol. |
| Arm/Group Title | BKM120 100mg + Fulvestrant | Placebo + Fulvestrant |
|---|---|---|
 Arm/Group Description |
BKM120 100 mg per day and fulvestrant given until progression or as described in the protocol. | BKM120 matching placebo daily and fulvestrant given until progression or as described in the protocol. |
| Period Title: Randomization Phase | ||
| Started [1] | 576 | 571 |
| Safety Set (SS) [2] | 573 | 570 |
| Completed [3] | 574 | 569 |
| Not Completed | 2 | 2 |
| Reason Not Completed | ||
| Adverse Event | 1 | 0 |
| Physician Decision | 1 | 1 |
| Death | 0 | 1 |
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[1]
All randomized patients (FAS)
[2]
At least 1 dose of study treatment and a 1 post baseline safety assessment
[3]
Randomized and treated
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| Period Title: Treatment Phase | ||
| Started [1] | 574 | 569 |
| BKM120 Pharmacokinetic Analysis Set [2] | 93 | 0 |
| Full Pharmacokinetic Analysis Set (FPAS) [3] | 35 | 0 |
| Completed | 0 | 0 |
| Not Completed | 574 | 569 |
| Reason Not Completed | ||
| Adverse Event | 80 | 12 |
| Lost to Follow-up | 1 | 0 |
| Non-compliance with Study Treatment | 8 | 1 |
| Physician Decision | 27 | 24 |
| Progressive Disease | 377 | 486 |
| Protocol Deviation | 2 | 3 |
| Study terminated by Sponsor | 18 | 15 |
| Subject/Guardian Decision | 55 | 23 |
| Death | 6 | 5 |
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[1]
All patients in FAS that were treated
[2]
At least one dose of Buparlisib and 1 evaluable buparlisib concentration measurement
[3]
A subset of the patients in the Buparlisib PAS
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| Period Title: Post-Treatment Efficacy Follow-Up Phase | ||
| Started [1] | 89 [2] | 29 [2] |
| Completed | 0 | 0 |
| Not Completed | 89 | 29 |
| Reason Not Completed | ||
| Adverse Event | 2 | 0 |
| Physician Decision | 10 | 3 |
| Progressive Disease | 24 | 8 |
| Subject/Guardian Decision | 11 | 1 |
| Death | 4 | 4 |
| New therapy for study indication | 38 | 13 |
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[1]
All patients who discontinued treatment and entered Post-Treatment Efficacy Follow-Up Phase
[2]
All patients who entered Post-Treatment Efficacy Fup Phase
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Baseline Characteristics
| Arm/Group Title | BKM120 100mg + Fulvestrant | Placebo + Fulvestrant | Total | |
|---|---|---|---|---|
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Arm/Group Description |
BKM120 100 mg per day and fulvestrant given until progression or as described in the protocol. | BKM120 matching placebo daily and fulvestrant given until progression or as described in the protocol. | Total of all reporting groups | |
| Overall Number of Baseline Participants | 576 | 571 | 1147 | |
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Baseline Analysis Population Description |
Full Analysis Set (FAS)
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 576 participants | 571 participants | 1147 participants | |
| <=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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| Between 18 and 65 years |
329 57.1%
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378 66.2%
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707 61.6%
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| >=65 years |
247 42.9%
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193 33.8%
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440 38.4%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 576 participants | 571 participants | 1147 participants | |
| 62.2 (10.20) | 60.6 (10.08) | 61.4 (10.17) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||||
| Number Analyzed | 576 participants | 571 participants | 1147 participants | |
| Female |
576 100.0%
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571 100.0%
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1147 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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Race/Ethnicity, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 576 participants | 571 participants | 1147 participants |
| Asian | 132 | 153 | 285 | |
| Black | 5 | 16 | 21 | |
| Caucasian | 402 | 376 | 778 | |
| Other | 18 | 7 | 25 | |
| Unknown | 19 | 18 | 37 | |
| Missing | 0 | 1 | 1 | |
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ECOG Performance Status
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 576 participants | 571 participants | 1147 participants | |
| Grade 0 = No Restrictions |
333 57.8%
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344 60.2%
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677 59.0%
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| Grade 1 = Only Light Work |
231 40.1%
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211 37.0%
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442 38.5%
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| Grade 2 = Only Self Care |
11 1.9%
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16 2.8%
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27 2.4%
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| Grade 3 = Only Limited Self-Care |
1 0.2%
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0 0.0%
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1 0.1%
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Outcome Measures
Adverse Events
Limitations and Caveats
Novartis made the decision not to pursue further development of buparlisib and to terminate the ongoing studies in Breast Cancer. The CBKM120F2302 study was terminated on 19-Apr-2019 (last subject last visit).
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 the pooled data (ie, data from all sites) in the clinical trial.
Results Point of Contact
| Name/Title: | Study Director |
| Organization: | Novartis Pharmaceuticals |
| Phone: | 862-778-8300 |
| EMail: | Novartis.email@novartis.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT01610284 |
| Other Study ID Numbers: |
CBKM120F2302 2011-005524-17 ( EudraCT Number ) |
| First Submitted: | May 11, 2012 |
| First Posted: | June 4, 2012 |
| Results First Submitted: | April 15, 2020 |
| Results First Posted: | June 18, 2020 |
| Last Update Posted: | August 25, 2020 |