Cited by 2,622Advanced Breast Cancer TherapiesPI3K/AKT/mTOR signaling in cancerBreast Cancer Treatment Studies

The DOI matches its Crossref record; 24 of the 25 references it cites were found in a registry or an index.

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

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Abstract

BACKGROUND: 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: -mutated cancer. Secondary end points included overall response and safety. RESULTS: -mutated cancer was greater with alpelisib-fulvestrant than with placebo-fulvestrant (26.6% vs. 12.8%); among patients with measurable disease in this cohort, the percentages were 35.7% and 16.2%, respectively. In the overall population, the most frequent adverse events of grade 3 or 4 were hyperglycemia (36.6% in the alpelisib-fulvestrant group vs. 0.7% in the placebo-fulvestrant group) and rash (9.9% vs. 0.3%). Diarrhea of grade 3 occurred in 6.7% of patients in the alpelisib-fulvestrant group, as compared with 0.3% of those in the placebo-fulvestrant group; no diarrhea of grade 4 was reported. The percentages of patients who discontinued alpelisib and placebo owing to adverse events were 25.0% and 4.2%, respectively. CONCLUSIONS: -mutated, HR-positive, HER2-negative advanced breast cancer who had received endocrine therapy previously. (Funded by Novartis Pharmaceuticals; SOLAR-1 ClinicalTrials.gov number, NCT02437318.).

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Crossref · 10.1056/nejmoa1813904

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  1. Juric D, Janku F, Rodón J, et al. Alpelisib plus fulvestrant in PIK3CA-altered and PIK3CA-wild-type estrogen receptor-positive advanced breast cancer: a phase 1b clinical trial. JAMA Oncol 2018 December 13 (Epub ahead of print).30543347
  2. Juric D Ciruelos E Rubovszky G et al. Alpelisib + fulvestrant for advanced breast cancer: subgroup analyses from the phase III SOLAR-1 trial. Presented at the San Antonio Breast Cancer Symposium San Antonio TX December 4–8 2018. abstract.

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Metadata

Authors
André, F., Ciruelos, E., Rubovszky, G., Campone, M., Loibl, S., Rugo, H. S., Iwata, H., Conte, P., Mayer, I. A., Kaufman, B., Yamashita, T., Lu, Y.-S., Inoue, K., Takahashi, M., Pápai, Z., Longin, A.-S., Mills, D., Wilke, C., Hirawat, S., & Juric, D.
Affiliations
  • Université Paris-Sud (FR)
  • From Institut Gustave Roussy, INSERM Unité 981, Université Paris-Sud, Villejuif (F.A.), Institut de Cancérologie de l’Ouest, St. Herblain (M.C.), and Novartis Pharma, Paris (A.-S.L.) — all in France; Hospital Universitario 12 de Octubre, Madrid (E.C.); National Institute of Oncology (G.R.) and Duna Medical Center (Z.P.), Budapest, Hungary; German Breast Group, Neu-Isenburg, and Center for Hematology and Oncology Bethanien, Frankfurt — both in Germany (S.L.); UCSF Helen Diller Family Comprehensive...
Venue
New England Journal of Medicine
Published
2019-05-16
Volume
380
Issue
20
Pages
1929-1940
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
OpenAlex
W2945564879
Cited by
2,622
References
25
Citations by year
2026: 314 · 2025: 356 · 2024: 370 · 2023: 329 · 2022: 375 · 2021: 450 · 2020: 345 · 2019: 81
FWCI
231.43
Type
journal article
Language
en
Open access
Locations
  • New England Journal of Medicine (publishedVersion)
  • PubMed (publishedVersion)
  • Hispana (publishedVersion)
  • Padua Research Archive (University of Padova) (submittedVersion, other-oa)
Funders
Pharmaceuticals Corporation
Topics
  • Health Sciences › Medicine › Oncology › Advanced Breast Cancer Therapies
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › PI3K/AKT/mTOR signaling in cancer
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Breast Cancer Treatment Studies
Keywords
alpelisib, PIK3CA mutation, hormone receptor-positive breast cancer, HER2-negative breast cancer, advanced breast cancer, PI3Kα inhibitor, fulvestrant, endocrine therapy, hyperglycemia, diarrhea, adverse events
MeSH terms
Fulvestrant, Progression-Free Survival, Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Breast Neoplasms, Diarrhea, Female, Humans, Middle Aged, Mutation, Receptors, Estrogen, Receptors, Progesterone, Thiazoles, Erb-b2 Receptor Tyrosine Kinases, Antineoplastic Agents, Hormonal, Class I Phosphatidylinositol 3-Kinases

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