Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men and Postmenopausal Women With Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment. (SOLAR-1)
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| ClinicalTrials.gov Identifier: NCT02437318 |
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Recruitment Status :
Completed
First Posted : May 7, 2015
Results First Posted : August 13, 2019
Last Update Posted : November 18, 2023
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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: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment |
| Condition |
Breast Cancer |
| Interventions |
Drug: Fulvestrant Drug: Alpelisib Drug: Alpelisib placebo |
| Enrollment | 572 |
Participant Flow
| Recruitment Details | A total of 340 subjects were planned for the PIK3CA mutant cohort and 341 were analyzed. A total of 220 subjects were planned for the PIK3CA non-mutant cohort and 231 were analyzed. |
| Pre-assignment Details |
| Arm/Group Title | Alpelisib qd + Fulvestrant | Placebo qd + Fulvestrant |
|---|---|---|
 Arm/Group Description |
Alpelisib (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle) | Placebo (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle) |
| Period Title: Overall Study | ||
| Started | 284 | 288 |
| End of Treatment (Didn't Complete) | 229 | 241 |
| Untreated (Protocol Deviation) | 0 | 1 |
| Completed [1] | 55 | 46 |
| Not Completed | 229 | 242 |
| Reason Not Completed | ||
| Progressive disease | 173 | 208 |
| Subject/guardian decision | 22 | 10 |
| Physician Decision | 11 | 10 |
| Adverse Event | 14 | 3 |
| Death | 4 | 4 |
| Protocol Violation | 5 | 6 |
| Untreated | 0 | 1 |
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[1]
Completed = Subjects ongoing at the time of data cut-off: 12-Jun-2018
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Baseline Characteristics
| Arm/Group Title | Alpelisib qd + Fulvestrant | Placebo qd + Fulvestrant | Total | |
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Arm/Group Description |
Alpelisib (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle) | Placebo (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle) | Total of all reporting groups | |
| Overall Number of Baseline Participants | 284 | 288 | 572 | |
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Baseline Analysis Population Description |
The Full analysis set (FAS) comprised of all subjects who were randomized to study treatment (alpelisib plus fulvestrant or matching placebo plus fulvestrant).
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 284 participants | 288 participants | 572 participants | |
| 62.6 (9.74) | 63.3 (10.26) | 63.0 (10.00) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 284 participants | 288 participants | 572 participants | |
| Female |
283 99.6%
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288 100.0%
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571 99.8%
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| Male |
1 0.4%
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0 0.0%
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1 0.2%
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Race/Ethnicity, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 284 participants | 288 participants | 572 participants |
| White | 199 | 178 | 377 | |
| Asian | 59 | 66 | 125 | |
| Unknown | 14 | 17 | 31 | |
| Other | 9 | 17 | 26 | |
| Black or African American | 2 | 6 | 8 | |
| American Indian or Alaska | 1 | 4 | 5 | |
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 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: | novartis.email@novartis.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT02437318 |
| Other Study ID Numbers: |
CBYL719C2301 2015-000340-42 ( EudraCT Number ) |
| First Submitted: | April 22, 2015 |
| First Posted: | May 7, 2015 |
| Results First Submitted: | June 17, 2019 |
| Results First Posted: | August 13, 2019 |
| Last Update Posted: | November 18, 2023 |