ITCC-104: HEM-iSMART International Proof of Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory HEMatological Malignancies in Children, Sub-Protocol E: Capivasertib + Venetoclax + Dexamethasone in Pediatric Patients With Relapsed or Refractory Hematological Malignancies

HEM-iSMART is a master protocol which investigates multiple investigational medicinal products in children, adolescents and young adults (AYA) with relapsed/refractory (R/R) ALL and LBL. Sub-protocol E is a phase I/II trial evaluating the safety and efficacy of capivasertib + venetocolax in combination with dexamethasone in children and AYA with R/R ped ALL/LBL whose tumor present with alterations of the PAM pathway, or lacking any mutations.

Start Date01 Oct 2026

Sponsor / Collaborator

Princess Maxima Centre For Pediatric Oncology

[+2]

CTIS2025-523460-21-00

/ Not yet recruitingPhase 2IIT

A multicenter, multicohort, phase 2 platform trial to personalize second-line treatment intensity and targeting in HR-positive, HER2-negative metastatic breast cancer through an integrated liquid biopsy algorithm.

Start Date01 Jun 2026

Sponsor / Collaborator-

NCT07486648

/ Not yet recruitingPhase 1/2IIT

The Safety and Efficacy of Osimertinib Plus Capivasertib in EGFRm Advanced Non-small Cell Lung Cancer (NSCLC) Participants With PIK3CA/AKT1/PTEN Alterations Who Had Progressed on First-line Osimertinib Monotherapy or Plus Chemotherapy: a First-in-human, Phase Ib/Ⅱa Study (PRECISION)

The goal of this clinical trial is to learn if Osimertinib plus Capivasertib works to treat EGFRm advanced non-small cell lung cancer (NSCLC) in participants with PIK3CA/AKT1/PTEN alterations after progression on first-line Osimertinib (monotherapy or plus chemotherapy).
The main questions it aims to answer are:
Part A:
* Number of Dose-limiting toxicities (DLTs)
* Adverse events (AEs)/serious adverse events (SAEs) (graded by CTCAE Version 5.0)
* Recommended combined dose (RCD)
Part B:Confirmed ORR assessed by the Investigator per RECIST 1.1 criteria.
Participants will:
Part A:Take Capivasertib twice daily from day 1 to 4 of a 7-day cycle, Osimertinib will be given orally QD(once daily) at 80 mg throughout the study treatment period.
Part B: Take Osimertinib (80mg QD, continuously) and Capivasertib(RCD,orally BID from day1-day 4 in 7-day cycle , 4 days on /3 days off) till disease progression (PD) or unacceptable toxicity.

Start Date15 May 2026

Sponsor / Collaborator

Shanxi Province Cancer Hospital

[+1]

100 Clinical Results associated with Capivasertib

100 Translational Medicine associated with Capivasertib

100 Patents (Medical) associated with Capivasertib

401

Literatures (Medical) associated with Capivasertib

31 Dec 2026·Hematology

Neutrophil extracellular trap-related genes in PTCL: identification, prognosis and drug interaction prediction via bioinformatics-machine learning

Article

Author: Chen, Jing ; Cheng, Fanjun ; Fang, Jun

OBJECTIVE:

This study aimed to identify neutrophil extracellular trap-related genes (NET-RGs), explore their prognostic significance, and predict drug interactions in peripheral T-cell lymphoma (PTCL).

METHODS:

Differentially expressed NET-RGs (DE-NRGs) between PTCL and normal tissues were screened. Functional enrichment analysis was conducted. Bioinformatics and machine learning were used to identify hub genes and assess their diagnostic value. Univariate and multivariate analyses were used to evaluate prognostic roles. Correlation and immune infiltration analyses were performed to explore relationships with the tumor microenvironment (TME). Clinical data were collected from PTCL patients who received potential agents (lenalidomide) as first-line treatment.

RESULTS:

A total of 31 DE-NRGs were identified (18 upregulated and 13 downregulated), enriched in inflammatory response, extracellular matrix organization, and infection involvement. Four hub genes (AKT2, MAPK14, IRF1, and TNF) were identified as effective PTCL diagnostic markers. Higher AKT2/MAPK14 expression correlated with poorer overall survival (OS), while elevated TNF expression associated with better OS; AKT2 and TNF independently predicted OS. These genes were implicated in modulating TME remodeling. Potential therapeutic agents (e.g. capivasertib, lenalidomide) were predicted, and lenalidomide may represent a feasible initial treatment option for PTCL, with an objective response rate (ORR) of 40.0% and a maximum survival duration exceeding 50 months.

CONCLUSION:

NET-RGs play crucial roles in diagnosis, prognosis, and TME regulation, and lenalidomide, a putative TNF-targeting agent, may represent a feasible initial treatment option in PTCL.

01 Dec 2026·JOURNAL OF COMPUTER-AIDED MOLECULAR DESIGN

AI-driven peptide discovery for endometrial cancer: deep generative modeling and molecular simulation in the big data era

Article

Author: Meng, Yuxuan ; Fatima, Israr ; Ur Rehman, Hafeez ; Aldaw, Mohamed ; Rehman, Abdur ; Li, Yan ; Wang, Zhibo ; Liao, Mingzhi ; Warraich, Dawood Ahmed

The integration of artificial intelligence (AI) with molecular modeling offers new opportunities to accelerate therapeutic discovery. In this study, we developed an AI-driven generative pipeline combining deep reinforcement learning (DRL), generative adversarial networks (GANs), and variational autoencoders (VAEs) to design novel peptide-like molecules targeting major proteins implicated in endometrial cancer (EC), including AKT1, ESR1, Connexin-43, and CTNNB1. From over 14,200 generated structures, approximately 2313 peptides met drug-likeness and structural criteria and were screened using deep learning-enhanced docking. Top-ranked peptides, such as Gitoxoside (- 11.53 kcal/mol) and 9-Fluoro-11 (- 11.38 kcal/mol), demonstrated stronger binding to AKT1 than the reference inhibitor Capivasertib (- 8.50 kcal/mol). Similar high-affinity interactions were observed for CTNNB1-SCHEMBL (- 12.33 kcal/mol) and ESR1-1Estra-1,3 (- 11.05 kcal/mol). Molecular dynamics (MD) simulations confirmed the stability of these complexes with RMSD values below 2.5 Å and minimal residue fluctuations. WaterSwap free energy calculations yielded highly favorable binding energies (- 34 to - 37 kcal/mol), further validating stable ligand-protein interactions. ADMET predictions indicated acceptable pharmacokinetic properties and low predicted toxicity for most candidates. Collectively, this integrative AI framework efficiently explores peptide chemical space, enabling the rapid identification of peptide-based and peptidomimetic inhibitors with strong binding affinity and stability. The findings highlight the potential of AI-assisted peptide design as a scalable and cost-effective strategy for developing next-generation therapeutics against endometrial cancer.

01 Apr 2026·EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY

Synthesis of potent human DHRS11 inhibitors and their efficacy against androgen-dependent proliferation and sensitivity to AKT inhibitor Capivasertib of triple-negative breast cancer cells

Article

Author: Endo, Satoshi ; Kobayashi, Nao ; Tanio, Masatoshi ; Kudo, Yudai ; Toyooka, Naoki ; Saka, Tomofumi ; Nakagawa, Yusuke ; Hirai, Wakana ; Yoshino, Yuta ; Kandeel, Mahmoud ; Miyamoto, Yuri ; Okada, Takuya ; Takada, Sana ; Ikari, Akira ; Tanaka, Nobutada

Triple-negative breast cancer (TNBC) is a highly aggressive subtype of breast cancer lacking estrogen receptor (ER), progesterone receptor (PR), and HER2 expression. Among its heterogeneous subtypes, luminal androgen receptor-positive (LAR) TNBC is driven by androgen signaling and presents limited treatment options. We previously identified dehydrogenase/reductase SDR family member 11 (DHRS11) as a novel enzyme involved in androgen biosynthesis, and demonstrated that Kobochromone A (KC-A), a polyphenol isolated from Carex kobomugi, inhibited androgen-driven proliferation in LAR TNBC cells via DHRS11 inhibition and AR downregulation. In this study, we synthesized 23 structural derivatives of KC-A and identified WH23 as the most potent DHRS11 inhibitor (IC₅₀ = 37 nM). Molecular docking and MM-PBSA analysis revealed that the 2'-hydroxy group of WH23 forms a hydrogen bond with His210 of DHRS11, which was validated by site-directed mutagenesis. WH23 suppressed AR mRNA and protein expression, reduced 11-ketodihydrotestosterone (11KDHT)-induced c-Myc expression, and inhibited proliferation of MDA-MB-453 cells. Additionally, WH23 inhibited PI3K/AKT signaling, reducing phosphorylation of PDK1, AKT, mTOR, and ERK. Capivasertib (Cap), a clinically approved pan-AKT inhibitor, induced DHRS11 expression in MDA-MB-453 cells. Although Cap and WH23 did not show synergistic cytotoxicity in parental cells, Cap-resistant (Cap-R) cells, which exhibited elevated DHRS11 and c-Myc expression, showed significant sensitivity to the combination. In Cap-R cells, the combination of Cap and WH23 significantly induced apoptosis, demonstrating a synergistic anticancer effect. These findings establish WH23 as a dual-acting compound targeting both androgen biosynthesis and AR signaling, with potential to overcome AKT inhibitor resistance in LAR TNBC.

206

News (Medical) associated with Capivasertib

06 May 2026

·www.astrazeneca.com

The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) has recognised a favourable benefit risk profile for AstraZeneca’s Truqap (capivasertib) in combination with abiraterone and androgen deprivation therapy (ADT) for the treatment of patients with PTEN-deficient metastatic hormone-sensitive prostate cancer (mHSPC), based on the CAPItello-281 Phase III trial. The Committee voted 7 to 1, with 1 abstaining. In August 2025, the FDA accepted the supplemental New Drug Application (sNDA) for Truqap in combination with abiraterone and ADTbased on positive results from the CAPItello-281 Phase III trial, presented at the 2025 European Society for Medical Oncology (ESMO) Congress and simultaneously published in Annals of Oncology.1 Daniel George, MD, Director of Genitourinary Oncology at Duke Cancer Institute and investigator for the trial, said: “Patients identified to have PTEN-deficient metastatic hormone-sensitive prostate cancer have an aggressive form of the disease and currently experience poor outcomes. Their disease significantly impacts their quality of life and inevitably progresses to more advanced stages that are associated with high mortality rates. In addition to this poor prognosis, patients currently have limited treatment options, which is why today’s recommendation of the capivasertib combination is welcome news for both patients and clinicians to address an urgent need for new treatments that delay progression.” Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: “CAPItello-281 is the first pivotal trial to prospectively define PTEN-deficient metastatic hormone-sensitive prostate cancer and its severe course of disease. The Committee’s recognition of the unmet need in patients with PTEN-deficiency and of the benefit seen with the Truqap combination verifies its potential to address this significant need and optimise outcomes for patients. We are committed to working closely with the FDA to bring the first and only targeted treatment option to the one in four patients with this form of metastatic hormone-sensitive prostate cancer.” Results from the primary analysis of the CAPItello-281 Phase III trial showed a statistically significant 19% reduction in the risk of radiographic disease progression or death and a clinically meaningful improvement in median radiographic progression-free survival (rPFS) of 7.5 months with the Truqap combination versus treatment with abiraterone and ADT with placebo (based on a hazard ratio [HR] of 0.81; 95% confidence interval [CI] 0.66-0.98; p=0.034). Median rPFS was 33.2 months for the Truqap combination versus 25.7 months for the comparator arm.1 A consistent benefit was observed with the Truqap combination versus treatment with abiraterone and ADT with placebo in key secondary endpoints of the trial, including prolonged time to castration resistance (29.5 vs. 22.0 months [HR 0.77; 95% CI: 0.63-0.94]) and prostate-specific antigen (PSA) progression (HR 0.73; 95% CI: 0.52-1.01), and fewer and delayed events in terms of symptomatic skeletal event-free survival (SSE-FS) (42.5 vs. 37.3 months [HR 0.82, 95% CI: 0.66-1.02]).1 Overall survival (OS) data were immature at the time of primary analysis; however, subsequent interim results for OS numerically favoured the Truqap combination versus the comparator arm. The trial will continue as planned to further assess OS as a key secondary endpoint. The safety profile of Truqap in combination with abiraterone and ADT in CAPItello-281 was broadly consistent with the known profile of each medicine.Consistent with the addition of a targeted treatment to background therapy, Grade 3 or higher adverse events occurred in 67% of patients treated with the Truqap combination versus 40.4% of patients treated with abiraterone and ADT with placebo. The most common Grade 3 or higher adverse events in the Truqap arm were rash (12.3%), hyperglycaemia (10.3%), hypokalaemia (8.7%), diarrhoea (6.2%), hypertension (5.8%) and anaemia (5.2%).1 The ODAC provides the FDA with independent, expert advice and recommendations on marketed and investigational medicines for use in the treatment of cancer. The FDA will consider the feedback as it reviews the submission and is not bound by the Committee’s recommendation. A regulatory application for Truqap in combination with abiraterone and ADT for the treatment of PTEN-deficient mHSPC is under review in the EU based on the CAPItello-281 Phase III trial. AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Social Media @AstraZeneca. References Fizazi K, et al. Capivasertib plus abiraterone in PTEN-deficient metastatic hormone sensitive prostate cancer: CAPItello-281 phase III study.Ann Oncol2026; 37(1):53-68. Bray F, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 Apr 4. doi: 10.3322/caac.21834. American Cancer Society. Key Statistics for Prostate cancer. Available at: https://www.cancer.org/cancer/types/prostate-cancer/about/key-statistics.html. Accessed April 2026. Chowdhury S, et al. Real-World Outcomes in First-Line Treatment of Metastatic Castration-Resistant Prostate Cancer: The Prostate Cancer Registry. Target Oncol. 2020;15(3):301-315. National Cancer Institute. Hormone Therapy for Prostate Cancer Fact Sheet. Available at: https://www.cancer.gov/types/prostate/prostate-hormone-therapy-fact-sheet. Accessed April 2026. American Society of Clinical Oncology Educational Book. Metastatic Hormone-Sensitive Prostate Cancer: Toward an Era of Adaptive and Personalized Treatment. Available at: https://ascopubs.org/doi/pdf/10.1200/EDBK_390166. Accessed April 2026. Cancer Research UK. Hormone therapy for metastatic prostate cancer. Available at: https://www.cancerresearchuk.org/about-cancer/prostate-cancer/metastatic-cancer/treatment/hormone-therapy-for-metastatic-prostate-cancer. Accessed April 2026. Hussain M, et al. Metastatic Hormone-Sensitive Prostate Cancer and Combination Treatment Outcomes A Review. JAMA Oncol. 2024;10(6):807-820. Cerner CancerMPact database. Accessed April 2026. Cuzick J, et al. Prognostic value of PTEN loss in men with conservatively managed localised prostate cancer. Br J Cancer. 2013;108(12):2582-2589. Gasmi A, et al. Overview of the Development and Use of Akt Inhibitors in Prostate Cancer. J Clin Med. 2021;11(1):160. The content above comes from the network. if any infringement, please contact us to modify.

Truqap recommended by FDA Advisory Committee for PTEN-deficient metastatic hormone-sensitive prostate cancer

Clinical ResultDrug Approval

04 May 2026

·www.biopharmadive.com

Celcuity strengthens case for ASCO-spotlighted breast cancer drug

Dive Brief:Celcuity said Friday its experimental breast cancer drug succeeded in another part of an ongoing Phase 3 trial, positioning the company to seek broader approval of a treatment thats already undergoing a regulatory review.According to Celcuity, two- and three-drug combinations involving its therapy gedatolisib helped delay disease progression compared to a regimen with Novartis targeted medication Piqray and hormone therapy. Celcuity tested those combinations in people whose tumors were driven by a mutation in the PIK3CA gene and said, without specifics, that treatment was associated with a statistically significant and clinically meaningful improvement. The results will be featured at the upcoming American Society of Clinical Oncology meeting, which begins on May 29.Celcuity previously reported that gedatolisib appeared to help breast cancer patients without confirmed PIK3CA mutations. The company has already filed for U.S. approval, and a decision is expected by July 17. Celcuity intends to submit the new data in a supplemental application that could expand use to include people with those mutations. Shares climbed more than 18% on Monday, pushing Celcuitys market value past $7 billion.Dive Insight:PIK3CA alterations are involved in a wide variety of cancers and, notably, an estimated 40% of people with a breast tumor thats hormone receptor positive, but negative for the protein HER2. Thats made them an increasingly popular target among drugmakers looking for medicines that can block their activity.A few treatments, such as Piqray, Roches Itovebi and AstraZenecas Truqap, are already available. But all are associated with side effects, such as skin rashes, gastrointestinal issues and hyperglycemia, that can hinder uptake.Celcuity is among several companies looking to bring to market better treatments that are either more selective or potent. Its already close to an approval, following Phase 3 data last July that showed gedatolisib combinations significantly delayed disease progression compared to two other established drug regimens.But investors and analysts have been watching for additional results from that same trial that specifically included people with confirmed PIK3CA mutations. A meaningful improvement in that cohort could yield a broader market opportunity for Celcuity and help the drug separate itself from other therapies.Heading into the data readout, analysts generally expected positive findings. But the fact that the two-drug combination including gedatolisib hit statistical significance is particularly notable, wrote Jefferies analyst Maury Raycroft. The finding suggests at least a two- to three-month separation from the control arm, he predicted.The newly disclosed inclusion of Celcuitys data at ASCO also bodes well for the magnitude of benefit associated with treatment, wrote Leerink Partners analyst Andrew Berens. Presentations were first announced last month, suggesting ASCO may have let Celcuity submit its results after the deadline, he added.The meeting will be held from May 29 to June 2 in Chicago. '

Phase 3ASCOClinical ResultPhase 2

01 May 2026

·allsci.com

FDA advisory committee recommends AstraZeneca’s Truqap for PTEN-deficient prostate cancer

AstraZeneca’s Truqap (capivasertib) received a positive recommendation from the US FDA’s Oncologic Drugs Advisory Committee (ODAC) for use in patients with PTEN-deficient metastatic hormone-sensitive prostate cancer (mHSPC), a vote that follows the agency’s acceptance of a supplemental New Drug Application (sNDA) in August 2025. The committee voted 7 to 1, with one abstention, in favor of the benefit-risk profile of capivasertib in combination with abiraterone and androgen deprivation therapy (ADT). The ODAC recommendation does not constitute a final FDA approval decision, and the agency is not bound by the committee’s conclusions. The sNDA seeks approval for Truqap in combination with abiraterone and ADT for adult patients with PTEN-deficient mHSPC, a subgroup estimated to represent approximately one in four patients diagnosed with the disease in the US each year. Truqap is administered at 400 mg twice daily on an intermittent schedule of four days on and three days off. AstraZeneca has also submitted a regulatory application for the same indication in the European Union, where it remains under review. The company has not disclosed a specific PDUFA date in connection with the US filing. The submission is supported by results from the CAPItello-281 Phase III trial, a double-blind, randomized, placebo-controlled study that enrolled 1,012 adults with histologically confirmed de novo hormone-sensitive prostate adenocarcinoma and centrally confirmed PTEN deficiency. Patients were randomized to receive either capivasertib plus abiraterone and ADT or placebo plus abiraterone and ADT. The primary endpoint was radiographic progression-free survival (rPFS) as assessed by the investigator. Results from the primary analysis, presented at the 2025 European Society for Medical Oncology Congress and simultaneously published in the Annals of Oncology, showed a statistically significant 19% reduction in the risk of radiographic disease progression or death with the capivasertib combination, corresponding to a hazard ratio of 0.81 (95% CI: 0.66–0.98; p\=0.034). Median rPFS was 33.2 months in the capivasertib arm versus 25.7 months in the comparator arm, a difference of 7.5 months. Secondary endpoints showed consistent directional benefit: time to castration resistance was 29.5 versus 22.0 months (HR 0.77; 95% CI: 0.63–0.94), and symptomatic skeletal event-free survival was 42.5 versus 37.3 months (HR 0.82; 95% CI: 0.66–1.02). PSA progression favored the capivasertib arm with an HR of 0.73 (95% CI: 0.52–1.01). Overall survival data were immature at the time of the primary analysis, though interim results numerically favored the capivasertib combination; the trial is ongoing to assess OS as a key secondary endpoint. The safety profile observed in CAPItello-281 was broadly consistent with the known profiles of each component. Grade 3 or higher adverse events occurred in 67% of patients in the capivasertib arm versus 40.4% in the placebo arm. The most common high-grade events in the capivasertib group included rash (12.3%), hyperglycemia (10.3%), hypokalemia (8.7%), diarrhea (6.2%), hypertension (5.8%), and anemia (5.2%). The filing adds to a growing body of evidence linking PI3K/AKT pathway dysregulation to aggressive prostate cancer biology. PTEN loss, which occurs in roughly one in four patients with mHSPC, removes a key brake on AKT signaling, driving tumor growth and contributing to resistance to androgen receptor pathway inhibition. Capivasertib is a pan-AKT inhibitor targeting all three isoforms — AKT1, AKT2, and AKT3 — and its development in PTEN-deficient prostate cancer is grounded in the hypothesis that blocking this downstream pathway may complement the androgen-deprivation strategies that form the backbone of current standard care. Truqap already holds FDA approval in combination with fulvestrant for hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer with PIK3CA, AKT1, or PTEN alterations, based on results from the CAPItello-291 trial. The prostate cancer filing would constitute a new indication and a mechanistically distinct clinical context, given the combination partner and patient population involved. AstraZeneca is also evaluating capivasertib in a Phase Ib/III breast cancer program, CAPItello-292, which remains in active recruitment. Globally, prostate cancer accounts for more than 1.4 million new diagnoses annually and approximately 397,000 deaths, making it the fifth leading cause of cancer death in men worldwide. In the US, it is the most common cancer in men, with more than 300,000 new cases each year. Among patients diagnosed with metastatic disease, five-year survival rates remain low. PTEN-deficient tumors are associated with a measurably worse prognosis than PTEN-intact disease, and the absence of any approved therapy targeting this subgroup has represented a recognized gap in the treatment landscape. The FDA will issue its final decision independently of the ODAC vote. This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/ Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

100 Deals associated with Capivasertib

External Link

KEGG	Wiki	ATC	Drug Bank
D11371	-	-	DB12218

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
ER-positive/HER2-negative Breast Cancer	European Union	AstraZeneca AB	17 Jun 2024
ER-positive/HER2-negative Breast Cancer	Iceland	AstraZeneca AB	17 Jun 2024
ER-positive/HER2-negative Breast Cancer	Liechtenstein	AstraZeneca AB	17 Jun 2024
ER-positive/HER2-negative Breast Cancer	Norway	AstraZeneca AB	17 Jun 2024
Breast Cancer	Canada	AstraZeneca Canada, Inc.	26 Jan 2024
Hormone receptor positive HER2 negative breast cancer	United States	AstraZeneca Pharmaceuticals LP	16 Nov 2023

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Castration-sensitive prostate cancer	NDA/BLA	United States	AstraZeneca PLC	01 Aug 2025
HER2-negative breast cancer	Phase 3	Belgium	AstraZeneca PLC	27 Nov 2025
HER2-negative breast cancer	Phase 3	Germany	AstraZeneca PLC	27 Nov 2025
HER2-negative breast cancer	Phase 3	Portugal	AstraZeneca PLC	27 Nov 2025
Hormone receptor positive breast cancer	Phase 3	Belgium	AstraZeneca PLC	27 Nov 2025
Hormone receptor positive breast cancer	Phase 3	Germany	AstraZeneca PLC	27 Nov 2025
Hormone receptor positive breast cancer	Phase 3	Portugal	AstraZeneca PLC	27 Nov 2025
Metastatic breast cancer	Phase 3	Belgium	AstraZeneca PLC	27 Nov 2025
Metastatic breast cancer	Phase 3	Germany	AstraZeneca PLC	27 Nov 2025
Metastatic breast cancer	Phase 3	Portugal	AstraZeneca PLC	27 Nov 2025

Clinical Result

Indication

Phase

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


AACR2026	Phase 2/3	Hormone receptor positive HER2 negative breast cancer HR Positive \| HER2 Negative	16	Imlunestrant alone	oavlagmkma(oobigvrwrt) = idtqnpzezo hmhrubazyf (gbdsxeoyzr ) View more	Positive	21 Apr 2026
				Camizestrant 75mg	oavlagmkma(afrdrmhynd) = udayjriwdt yyrqlsousg (pdzmeoiism ) View more
NCT04862663 (CAPItello-292, SABCS2025)	-	Hormone receptor positive HER2 negative breast cancer HR+ \| HER2-	48	Capivasertib + CDK4/6i + fulvestrant	gykyflafww(nybzkjahpk) = zqhrqmoukw aikkvfgmfr (tjxzguszmp ) View more	Positive	11 Dec 2025
SABCS2025	Not Applicable	Hormone receptor positive breast cancer PIK3CA \| ESR1	107	alpelisib+fulvestrant	otwuuxncze(iwkceteero) = One patient with alpelisib experienced treatment interruption and dose reduction due to skin toxicity, while Elacestrant was well-tolerated without major adverse effects. mgycmkwzht (lpbbplenub )	Positive	10 Dec 2025
				capivasertib+fulvestrant
SABCS2025	Not Applicable	Hormone receptor positive HER2 negative breast cancer HR+ \| HER2- \| PI3K/AKT/PTEN pathway alterations	72	≥2 pathway inhibitors sequentially	dmfxjszzon(dmewmnjsrf) = hqzizpcunl mumzoszvdq (kbitehnaqh, 9 - 28)	Positive	10 Dec 2025
				alpelisib alone	dmfxjszzon(dmewmnjsrf) = yvdbeozmyv mumzoszvdq (kbitehnaqh, 5 - 8)
NCT03997123 (CAPItello-290, ESMO_ASIA2025)	Phase 3	Metastatic Triple-Negative Breast Carcinoma First line PIK3CA \| AKT1 \| PTEN	128	Capivasertib + paclitaxel	wejosbtnjw(ydrutrvalw) = utprlarvtx jmtesohqvz (ewbotlwicm ) View more	Positive	06 Dec 2025
				Placebo + paclitaxel	wejosbtnjw(ydrutrvalw) = cmqzkvwlof jmtesohqvz (ewbotlwicm ) View more
NCT03801369 (AMTEC, CTgov)	Phase 2	Metastatic breast cancer \| Metastatic Triple-Negative Breast Carcinoma	24	Quality-of-Life Assessment+Olaparib+Durvalumab (Arm I (Olaparib, Durvalumab))	paohgjnokb = nkgypgebip kwlmbvjwcz (kyvhzvocwx, poyprldiyb - eivsaftizl) View more	-	21 Nov 2025
				Quality-of-Life Assessment+Olaparib+selumetinib (Arm II (Olaparib, Selumetinib))	smermcjfdr(nxizxyetrl) = ctfftezfyd ddndvbleac (onttacwtpo, bzybvpipxk - nblroysfna) View more
NCT03660826 (NRG GY012, ESMO2025)	Phase 2	Metastatic endometrial cancer	168	Olaparib 300 mg PO BID + Durvalumab 1500mg q28 days	drrkccodyp(poetpukohf) = pkbnvzqhph pxeukxtaio (negkhyrwkt ) View more	Negative	17 Oct 2025
				Cediranib 30 mg PO Daily	drrkccodyp(poetpukohf) = xscnblirns pxeukxtaio (negkhyrwkt ) View more
ESMO2025	Not Applicable	Advanced breast cancer HR+ \| HER2-	16	Camizestrant	-	Positive	17 Oct 2025
				Ribociclib plus ET
NCT04742036 (Pubmed) Manual	Phase 1	Advanced Malignant Solid Neoplasm	16	Capivasertib (Part A)	jypyzzaimi(mhvnklxqzn) = Hyperglycemia, diarrhea, and rash were the most common. Most adverse events were Grade 1-2. kbmnifnzge (nbecowgask )	Positive	14 Oct 2025
				Capivasertib + Paclitaxel (Part B)
CAPItello-291 (ASCO2025)	Not Applicable	Hormone receptor positive HER2 negative breast cancer PIK3CA \| AKT \| PTEN ... View more	34	Capivasertib	kauikrckqc(apokxundnc) = cvfpqqbslk soawwnpiuo (wvryldbrxd, 2.4 - 7.6) View more	Positive	30 May 2025
				Alpelisib	-

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