Evidence map›Paper›PMID 40346047›Full record

Trial reportNature communications2025

Capivasertib plus fulvestrant in patients with HR-positive/HER2-negative advanced breast cancer: phase 3 CAPItello-291 study extended Chinese cohort.

Xichun Hu, Qingyuan Zhang, Tao Sun, Huihua Xiong, Wei Li, Yuee Teng, Yen-Shen Lu, Ling-Ming Tseng, Min Yan, Hongsheng Li and 14 more

Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Nature communications, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04305496 (A Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasertib + Fulvestrant Versus Placebo + Fulvestrant as Treatment for Locally Advanced), which is not on this map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
–field-weighted citation impact
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.

NCT04305496 phase3active not recruitingnot on this map

A Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasertib + Fulvestrant Versus Placebo + Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Breast Cancer Following Recurrence or Progression On or After Treatment With an Aromatase Inhibitor

TypeinterventionalSponsorAstraZenecaRan2020 to 2026Enrolled818ConditionsLocally Advanced (Inoperable) or Metastatic Breast CancerArmsFulvestrant, Capivasertib, Placebo
3 · Its place in the literature

Who cites it

16 citing papers in PubMed.

  1. The immunology of human breast cancer.Nature reviews. Immunology · 2026
    Review
  2. Article
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  6. Article
  7. Review
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  10. A novel prognostic and immune-related biomarkerTranslational cancer research · 2025
    Article
  11. Review
  12. Article
  13. Review
  14. Article
  15. Review
  16. Review
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

24 authors.

Xichun Hu *Department of Medical Oncology, Fudan University Shanghai Cancer Center; Fudan University, Shanghai, China. xchu2009@hotmail.com.ORCID http://orcid.org/0000-0001-6148-9186
Qingyuan Zhang *Harbin Medical University Cancer Hospital, Harbin, China.ORCID http://orcid.org/0000-0001-8116-5293
Tao SunLiaoning Cancer Hospital, Shenyang, China.ORCID http://orcid.org/0000-0001-5931-386X
Huihua XiongTongji Hospital, Tongji Medical College, Huazhong University of Science & Technology, Wuhan, China.
Wei LiThe First Hospital of Jilin University Cancer Center, Changchun, China.
Yuee TengThe First Hospital of China Medical University, Shenyang, China.
Yen-Shen LuNational Taiwan University Hospital, Taipei, Taiwan.ORCID http://orcid.org/0000-0001-7461-1291
Ling-Ming TsengTaipei Veterans General Hospital, Taipei, Taiwan.
Min YanThe Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China.ORCID http://orcid.org/0000-0002-3911-748X
Hongsheng LiAffiliated Tumor Hospital of Guangzhou Medical University, Guang Zhou Shi, China.
Danmei PangThe First People's Hospital of Foshan, Foshan, China.
Shin-Cheh -ChenDivision of Breast Surgery, Chang Gung Memorial Hospital, Linkou, Taoyuan, Taiwan.ORCID http://orcid.org/0000-0002-0177-0045
Wenyan ChenThe Third Hospital of Nanchang, Nanchang, China.
Ou JiangThe Second People's Hospital of Neijiang, Neijiang, China.
Jingfen WangLinyi Cancer Hospital, Linyi City, China.
Xinhong WuDepartment of Breast Surgery, Hubei Cancer Hospital, Tongji Medical College, Wuhan, Hubei, China.
Xian WangSir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Aimin ZangAffiliated Hospital of Hebei University, Baoding, China.
Xiaojia WangZhejiang Cancer Hospital, Hangzhou, China.ORCID http://orcid.org/0000-0002-7005-0842
Julie M CollinsOncology R&D, AstraZeneca, Gaithersburg, MD, USA.
Ethan FanOncology R&D, AstraZeneca, Shanghai, China.ORCID http://orcid.org/0009-0001-1333-112X
Lin JiangOncology R&D, AstraZeneca, Shanghai, China.
Xiaoling ZengOncology R&D, AstraZeneca, Shanghai, China.
Nicholas C TurnerRoyal Marsden Hospital, Institute of Cancer Research, London, UK.ORCID http://orcid.org/0000-0001-8937-0873

Funding

AstraZeneca N/A
6 · The paper itself

Abstract

In the global CAPItello-291 randomized phase 3 study (NCT04305496) in patients with hormone receptor-positive/HER2-negative advanced breast cancer and progression during/after aromatase inhibitor treatment, capivasertib-fulvestrant significantly improved progression-free survival (PFS) in the overall population and patients with PIK3CA/AKT1/PTEN-altered tumors versus placebo-fulvestrant. We assessed efficacy and safety of capivasertib-fulvestrant in a prespecified exploratory analysis of a Chinese cohort (n = 24) and extended study with the same protocol (n = 110). Clinically meaningful PFS benefit for capivasertib-fulvestrant was observed in the overall population (median PFS: 6.9 [capivasertib-fulvestrant] versus 2.8 [placebo-fulvestrant] months; hazard ratio 0.51, 95% CI 0.34-0.76), patients with PIK3CA/AKT1/PTEN-altered tumors (n = 46; 5.7 versus 1.9 months; hazard ratio 0.41, 95% CI 0.19-0.85) and PIK3CA/AKT1/PTEN-non-altered tumors (patients with confirmed next-generation sequencing results [n = 68]; 9.2 versus 2.7 months; hazard ratio 0.38; 95% CI 0.21-0.68). The most frequent adverse events (AEs) with capivasertib-fulvestrant were diarrhea (60.6% versus 11.3% with placebo-fulvestrant) and hyperglycemia (57.7% versus 17.7%). AEs leading to capivasertib-fulvestrant discontinuation were reported in 11.3% of patients versus 3.2% for placebo-fulvestrant. The benefit-risk profile of capivasertib-fulvestrant in the Chinese cohort was favorable; further exploration in patients with PIK3CA/AKT1/PTEN-non-altered tumors is warranted.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsFulvestrantPyrimidinesAdultAgedChinaClass I Phosphatidylinositol 3-KinasesCohort StudiesEast Asian PeopleErb-b2 Receptor Tyrosine KinasesFemaleHumansMiddle AgedProgression-Free SurvivalProto-Oncogene Proteins c-aktAKT1 protein, humancapivasertibClass I Phosphatidylinositol 3-KinasesERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesFulvestrantPIK3CA protein, humanProto-Oncogene Proteins c-aktPTEN PhosphohydrolasePTEN protein, humanPyrimidinesPyrrolesReceptors, EstrogenReceptors, Progesterone

Identifiers

PMID40346047
PMCPMC12064754

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Registered trials

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 OpenQuestion graph.