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.
NCT02437318 · SOLAR-1 Phase 3Completed
- Lead sponsor
- Novartis Pharmaceuticals (Industry)
- Enrollment
- 572 (actual)
- Start date
- 23 Jul 2015
- Primary completion
- 12 Jun 2018 (actual)
- Study completion
- 9 Jun 2023
- Last update posted
- 13 Feb 2025
Design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Randomized
- Intervention model
- Parallel
- Masking
- Triple
- Arms
- 2
Interventions
- Fulvestrant Drug
- Alpelisib Drug
- Placebo Drug
Conditions and primary outcome
- Breast Cancer
Primary outcome
Progression-free Survival (PFS) Per Investigator Assessment in the PIK3CA Mutant Cohort (Once approximately 243 PFS events in the PIK3CA mutant cohort had been observed, up to 33.3 months)
Posted results on ClinicalTrials.gov
Source: ClinicalTrials.gov results for NCT02437318 (opens in a new tab)· Licence: public-domain
First posted · Last update posted · Imported from ClinicalTrials.gov download 2026-10-25
Primary outcomes with a statistical analysis
Progression-free Survival (PFS) Per Investigator Assessment in the PIK3CA Mutant Cohort
- Time frame
- Once approximately 243 PFS events in the PIK3CA mutant cohort had been observed, up to 33.3 months
- Measure
- Median
- Unit
- Months
PIK3CA Mutant Cohort by Tumor Tissue: Alpelisib + Fulvestrant vs PIK3CA Mutant Cohort by Tumor Tissue: Placebo + FulvestrantSuperiority
- Estimate
- 0.65Hazard Ratio (HR)
- 95% CI, two-sided
- 0.50 to 0.85
- p-value
- 0.00065
- Method
- Log Rank
Serious adverse events
Time frame: All-cause mortality: from randomization up to approx. 6.5 years, including post-treatment survival follow up period. Serious and Other Adverse Events: from first dose of study treatment until 30 days after last dose up to approx. 6.5 years
| Group | Affected | At risk |
|---|---|---|
| Alpelisib + Fulvestrant | 110 | 284 |
| Placebo + Fulvestrant | 54 | 287 |
| Alpelisib + Fulvestrant (Post-treatment Survival Follow-up) | 0 | 0 |
| Placebo + Fulvestrant (Post-treatment Survival Follow-up) | 0 | 0 |
Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
Results from company and journal sources
No editor-confirmed results are on record for this study.
Publications
6 on PubMedSGLT2 inhibition improves PI3Kα inhibitor-induced hyperglycemia: findings from preclinical animal models and from patients in the BYLieve and SOLAR-1 trials.
Breast cancer research and treatment · 2024 Nov
PubMed 39177931 (opens in a new tab)DOI 10.1007/s10549-024-07405-8 (opens in a new tab)
A risk analysis of alpelisib-induced hyperglycemia in patients with advanced solid tumors and breast cancer.
Breast cancer research : BCR · 2024 Mar 4
PubMed 38439079 (opens in a new tab)DOI 10.1186/s13058-024-01773-1 (opens in a new tab)
Patient-Reported Outcomes in Patients With PIK3CA-Mutated Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer From SOLAR-1.
Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2021 Jun 20
PubMed 33780274 (opens in a new tab)DOI 10.1200/JCO.20.01139 (opens in a new tab)
Alpelisib plus fulvestrant for PIK3CA-mutated, hormone receptor-positive, human epidermal growth factor receptor-2-negative advanced breast cancer: final overall survival results from SOLAR-1.
Annals of oncology : official journal of the European Society for Medical Oncology · 2021 Feb
PubMed 33246021 (opens in a new tab)DOI 10.1016/j.annonc.2020.11.011 (opens in a new tab)
Time course and management of key adverse events during the randomized phase III SOLAR-1 study of PI3K inhibitor alpelisib plus fulvestrant in patients with HR-positive advanced breast cancer.
Annals of oncology : official journal of the European Society for Medical Oncology · 2020 Aug
PubMed 32416251 (opens in a new tab)DOI 10.1016/j.annonc.2020.05.001 (opens in a new tab)
Alpelisib for PIK3CA-Mutated, Hormone Receptor-Positive Advanced Breast Cancer.
The New England journal of medicine · 2019 May 16
PubMed 31091374 (opens in a new tab)DOI 10.1056/NEJMoa1813904 (opens in a new tab)
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.
CT-VCA trial quality
About CT-VCALoading CT-VCA scores…
Data integrity
Compare what the registry, company releases, FDA documents and publications say about this study.
Drugs on HealthTrade
Source
- NCT02437318 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
Nothing on this page is medical or investment advice.