Alpelisib for PIK3CA-Mutated, Hormone Receptor-Positive Advanced Breast Cancer

SOLAR-1 Study Group, Fabrice André, Eva Ciruelos, Gabor Rubovszky, Mario Campone, Sibylle Loibl, Hope S Rugo, Hiroji Iwata, Pierfranco Conte, Ingrid A Mayer, Bella Kaufman, Toshinari Yamashita, Yen-Shen Lu, Kenichi Inoue, Masato Takahashi, Zsuzsanna Pápai, Anne-Sophie Longin, David Mills, Celine Wilke, Samit HirawatDejan Juric, Michele Aieta

Research output: Contribution to journalArticlepeer-review


BACKGROUND: PIK3CA mutations occur in approximately 40% of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer. The PI3Kα-specific inhibitor alpelisib has shown antitumor activity in early studies.METHODS: In a randomized, phase 3 trial, we compared alpelisib (at a dose of 300 mg per day) plus fulvestrant (at a dose of 500 mg every 28 days and once on day 15) with placebo plus fulvestrant in patients with HR-positive, HER2-negative advanced breast cancer who had received endocrine therapy previously. Patients were enrolled into two cohorts on the basis of tumor-tissue PIK3CA mutation status. The primary end point was progression-free survival, as assessed by the investigator, in the cohort with PIK3CA-mutated cancer; progression-free survival was also analyzed in the cohort without PIK3CA-mutated cancer. Secondary end points included overall response and safety.RESULTS: A total of 572 patients underwent randomization, including 341 patients with confirmed tumor-tissue PIK3CA mutations. In the cohort of patients with PIK3CA-mutated cancer, progression-free survival at a median follow-up of 20 months was 11.0 months (95% confidence interval [CI], 7.5 to 14.5) in the alpelisib-fulvestrant group, as compared with 5.7 months (95% CI, 3.7 to 7.4) in the placebo-fulvestrant group (hazard ratio for progression or death, 0.65; 95% CI, 0.50 to 0.85; P
Original languageEnglish
Pages (from-to)1929-1940
Number of pages12
JournalNew England Journal of Medicine
Issue number20
Publication statusPublished - May 16 2019


  • Adult
  • Aged
  • 80 and over
  • Antineoplastic Agents
  • Hormonal/therapeutic use
  • Antineoplastic Combined Chemotherapy Protocols/adverse effects
  • Breast Neoplasms/drug therapy
  • Class I Phosphatidylinositol 3-Kinases/genetics
  • Diarrhea/chemically induced
  • Female
  • Fulvestrant/adverse effects
  • Humans
  • Male
  • Middle Aged
  • Mutation
  • Progression-Free Survival
  • Receptor
  • ErbB-2
  • Receptors
  • Estrogen
  • Progesterone
  • Thiazoles/adverse effects


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