ArticleNPJ breast cancer2021
Selective AKT kinase inhibitor capivasertib in combination with fulvestrant in PTEN-mutant ER-positive metastatic breast cancer.
Article in NPJ breast cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01226316 (A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD5363 Under Adaptable Dosing Schedules in Patients With Advanced Solid Malignancies), which is not on this map. Cited by 25 papers.
What it found
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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.
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.
A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD5363 Under Adaptable Dosing Schedules in Patients With Advanced Solid Malignancies
Who cites it
25 citing papers in PubMed, 35 citations in OpenAlex.
- Exploratory Analysis of PTEN Deficiency by Immunohistochemistry from the Phase III CAPItello-291 Trial.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026Trial
- Efficacy and Safety of Capivasertib (AZD5363), a Potent, Oral Pan-AKT Inhibitor, in Patients with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (CAPITAL).Clinical cancer research : an official journal of the American Association for Cancer Research · 2026Trial
- Evaluation of quantitative polymerase chain reaction for detecting BRCA1 or BRCA2 copy number loss in high-grade serous ovarian cancer.Scientific reports · 2026Article
- Dual Inhibition of PARP and Akt Induces Metabolic Collapse and Apoptosis in Breast Cancer Cells.Cancers · 2025Article
- PTEN-mediated resistance in cancer: From foundation to future therapies.Toxicology reports · 2025Review
- PTEN inactivating mutations are associated with hormone receptor loss during breast cancer recurrence.Breast cancer research and treatment · 2025Article
- Capivasertib enhances chimeric antigen receptor T cell activity in preclinical models of B cell lymphoma.Molecular therapy. Methods & clinical development · 2025Article
- Capivasertib: First Approved AKT inhibitor for the Treatment of Patients with Breast Cancer.Anti-cancer agents in medicinal chemistry · 2025Review
- Capivasertib/Fulvestrant in patients with HR+, HER2-low or HER2-negative locally advanced or metastatic breast cancer.Therapeutic advances in medical oncology · 2025Review
- Review
- AKT kinases as therapeutic targets.Journal of experimental & clinical cancer research : CR · 2024Review
- Capivasertib.Hospital pharmacy · 2024Article
- mTORC1-Driven Protein Translation Correlates with Clinical Benefit of Capivasertib within a Genetically Preselected Cohort of PIK3CA-Altered Tumors.Cancer research communications · 2024Article
- Capivasertib: First Approval.Drugs · 2024Review
- Therapy for Hormone Receptor-Positive, Human Epidermal Growth Receptor 2-Negative Metastatic Breast Cancer Following Treatment Progression via CDK4/6 Inhibitors: A Literature Review.Breast cancer (Dove Medical Press) · 2024Review
- Extensive review on breast cancer its etiology, progression, prognostic markers, and treatment.Medical oncology (Northwood, London, England) · 2023Review
- "The emerging role of capivasertib in breast cancer".Breast (Edinburgh, Scotland) · 2022Review
- Review
- Development of novel agents for the treatment of early estrogen receptor positive breast cancer.Breast (Edinburgh, Scotland) · 2022Review
- miR-338-3p blocks TGFβ-induced myofibroblast differentiation through the induction of PTEN.American journal of physiology. Lung cellular and molecular physiology · 2022Article
Corrections and comments
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Authors and funding
27 authors at 10 institutions in 7 countries.
Funding
Abstract
Five to ten percent of ER+ metastatic breast cancer (MBC) tumors harbor somatic PTEN mutations. Loss of function of this tumor-suppressor gene defines a highly aggressive, treatment-refractory disease for which new therapies are urgently needed. This Phase I multipart expansion study assessed oral capivasertib with fulvestrant in patients with PTEN-mutant ER+ MBC. Safety and tolerability were assessed by standard methods. Plasma and tumor were collected for NGS and immunohistochemistry analyses of PTEN protein expression. In 31 eligible patients (12 fulvestrant naive; 19 fulvestrant pretreated), the 24-week clinical benefit rate was 17% in fulvestrant-naive and 42% in fulvestrant-pretreated patients, with objective response rate of 8% and 21%, respectively. Non-functional PTEN was centrally confirmed in all cases by NGS or immunohistochemistry. Co-mutations occurred in PIK3CA (32%), with less ESR1 (10% vs 72%) and more TP53 (40% vs 28%) alterations in fulvestrant-naive versus fulvestrant-pretreated patients, respectively. PTEN was clonally dominant in most patients. Treatment-related grade ≥3 adverse events occurred in 32% of patients, most frequently diarrhea and maculopapular rash (both n = 2). In this clinical study, which selectively targeted the aggressive PTEN-mutant ER+ MBC, capivasertib plus fulvestrant was tolerable and clinically active. Phenotypic and genomic differences were apparent between fulvestrant-naive and -pretreated patients.Trial registration number for the study is NCT01226316.
Identifiers
What OpenQuestion holds
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.