Evidence map›Paper›PMID 33168657›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2021

FDA Approval Summary: Alpelisib Plus Fulvestrant for Patients with HR-positive, HER2-negative, PIK3CA-mutated, Advanced or Metastatic Breast Cancer.

Preeti Narayan, Tatiana M Prowell, Jennifer J Gao, Laura L Fernandes, Emily Li, Xiling Jiang, Junshan Qiu, Jianghong Fan, Pengfei Song, Jingyu Yu and 24 more

Open access · bronzeAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 103 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
103citing papers in PubMed, 3 pooled it
12.9field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

103 citing papers in PubMed, 3 syntheses or guidelines pooled it, 160 citations in OpenAlex.

  1. Pooled it
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  3. Pooled it
  4. Review
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  12. Targeting the PI3K/AKT/mTOR signaling pathway in prostate cancer: Molecular dysregulation, therapeutic advances, and future directions.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2026
    Review
  13. Current Status of Research on Losartan in Tumour Therapy.Journal of cellular and molecular medicine · 2026
    Review
  14. Review
  15. Review
  16. Review
  17. Ossifying fibromyxoid tumor with a novelRespiratory medicine case reports · 2026
    Article
  18. Article
  19. Review
  20. Article

43 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

34 authors at 4 institutions in 1 country.

Preeti NarayanCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland. preeti.narayan@fda.hhs.gov.
Tatiana M ProwellCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.ORCID 0000-0002-8065-3399
Jennifer J GaoCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.ORCID 0000-0003-1153-545X
Laura L FernandesCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.ORCID 0000-0002-5986-3885
Emily LiOncology Center of Excellence Summer Scholars Program, Silver Spring, Maryland.ORCID 0000-0002-0921-1344
Xiling JiangCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Junshan QiuCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Jianghong FanCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Pengfei SongCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Jingyu YuCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Xinyuan ZhangCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Bellinda L King-KallimanisCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Wei ChenCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Tiffany K RicksCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Yutao GongCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Xing WangCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Katherine WindsorCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Steve Y RhieuCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Gerlie GeiserCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Anamitro BanerjeeCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Xiaohong ChenCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Francisca Reyes TurcuCenter for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.
Deb K ChatterjeeCenter for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.
Anand PathakCenter for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.
Jeffrey SeidmanCenter for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.
Soma GhoshCenter for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.
Reena PhilipCenter for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.
Kirsten B GoldbergCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.ORCID 0000-0001-8659-1240
Paul G KluetzCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Shenghui TangCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Laleh Amiri-KordestaniCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Marc R TheoretCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Richard PazdurCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Julia A BeaverCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Center for Drug Evaluation and Research · USCenter for Devices and Radiological Health · USUnited States Food and Drug Administration · USSIL International · US

Funding

Intramural FDA HHS FD999999
6 · The paper itself

Abstract

On May 24, 2019, the FDA granted regular approval to alpelisib in combination with fulvestrant for postmenopausal women, and men, with hormone receptor (HR)-positive, HER2-negative, phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA)-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen. Approval was based on the SOLAR-1 study, a randomized, double-blind, placebo-controlled trial of alpelisib plus fulvestrant versus placebo plus fulvestrant. The primary endpoint was investigator-assessed progression-free survival (PFS) per RECIST v1.1 in the cohort of trial participants whose tumors had a PIK3CA mutation. The estimated median PFS by investigator assessment in the alpelisib plus fulvestrant arm was 11 months [95% confidence interval (CI), 7.5-14.5] compared with 5.7 months (95% CI, 3.7-7.4) in the placebo plus fulvestrant arm (HR, 0.65; 95% CI, 0.50-0.85; two-sided

Indexed as

MutationAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsClass I Phosphatidylinositol 3-KinasesDouble-Blind MethodDrug ApprovalErb-b2 Receptor Tyrosine KinasesFemaleFulvestrantHumansMaleMiddle AgedNeoplasm MetastasisAlpelisibClass I Phosphatidylinositol 3-KinasesERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesFulvestrantPIK3CA protein, humanReceptors, EstrogenThiazoles

Identifiers

PMID33168657
PMCPMC8535764
OpenAlexW3105871111

What Socratic holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.