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The first trial to show a PI3K inhibitor helps in breast cancers carrying a PIK3CA mutation, at the cost of high blood sugar and rash.
SOLAR-1, trial NCT02437318 sponsored by Novartis and reported in 2018, was the first trial to show that a PI3K inhibitor helps in breast cancers carrying a PIK3CA mutation, at the cost of high blood sugar and rash. It randomised 572 women with HR-positive, HER2-negative advanced breast cancer after an aromatase inhibitor to alpelisib or placebo with fulvestrant, met its primary progression-free survival endpoint in the 341 patients with the mutation and showed no benefit without it, while severe hyperglycaemia in about 37 percent limited uptake. OnCo links it to PIK3CA and PI3K-alpha as a target, alpelisib, fulvestrant and Fabrice André. Whether alpelisib keeps a role as selective inhibitors arrive is the open question.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
572 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survival (PIK3CA-mutant)primary | Alpelisib + fulvestrant | 169 | 11 months | 0.65 (0.5 to 0.85) | <0.001 | link |
| Placebo + fulvestrant | 172 | 5.7 months |
A second publication from the SOLAR-1 trial, later than the first and described in its title as an update or longer-term analysis. Read it with the primary publication linked from the trial page; the record was linked automatically and its figures have not been checked by hand.
PIK3CA testing became routine in advanced hormone receptor-positive breast cancer, with alpelisib-fulvestrant the first approved PI3K-targeted regimen; capivasertib and inavolisib now offer alternatives.
Shares Alpelisib, PI3K, AKT and mTOR inhibitors, HR-positive metastatic breast cancer after CDK4/6 inhibitors, Fulvestrant.
Shares Alpelisib, PI3K, AKT and mTOR inhibitors, HR-positive metastatic breast cancer after CDK4/6 inhibitors, Fulvestrant.
Shares PI3K, AKT and mTOR inhibitors, HR-positive metastatic breast cancer after CDK4/6 inhibitors, Fulvestrant, Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test.
Shares Alpelisib, PI3K, AKT and mTOR inhibitors, Fulvestrant, Novartis.
Shares Alpelisib, PI3K, AKT and mTOR inhibitors, Fulvestrant, Novartis.
Shares Alpelisib, PI3K, AKT and mTOR inhibitors, Novartis, Small-molecule kinase inhibitors.
Shares Alpelisib, PI3K, AKT and mTOR inhibitors, Fulvestrant, Novartis.
Shares PI3K, AKT and mTOR inhibitors, HR-positive metastatic breast cancer after CDK4/6 inhibitors, Fulvestrant, PIK3CA / PI3K-alpha.