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NCT04524000
Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant in Japanese Men and Postmenopausal Women With Advanced Breast Cancer
Phase 2 trial testing Alpelisib in Advanced Breast Cancer in 24 participants. Participants enrolled and being followed up; not accepting new ones.
26 February 2027
Quick facts
| Lead sponsor | Novartis Pharmaceuticals |
|---|---|
| Phase | Phase 2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 8 January 2021 |
| Primary completion | 26 February 2027 |
| Estimated completion | 27 February 2027 |
| Sites | 15 locations across Japan |
Drugs / interventions tested
- Alpelisib (alpelisib) — full drug profile →
- Fulvestrant (fulvestrant) — full drug profile →
Conditions studied
- Advanced Breast Cancer — all drugs for Advanced Breast Cancer →
Sponsor
Novartis Pharmaceuticals — full company profile →
Who can join
Adults 18 to 100, any sex, with Advanced Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to assess the safety and efficacy of alpelisib plus fulvestrant in men and postmenopausal women with hormone receptor (HR) positive, human epidermal growth factor 2 (HER2)-negative, advanced breast cancer harboring a PIK3CA mutation in Japan, whose disease has progressed on or after aromatase inhibitor (AI) treatment regardless of prior CDK4/6 inhibitor use.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
The emerging role of PI3K inhibitors for solid tumour treatment and beyond.
Belli C, Repetto M, Anand S, Porta C, et al · · 2023 · cited 53× · PMID 36914722 · DOI 10.1038/s41416-023-02221-1 -
Whole-Exome Sequencing of HPV Positive Tonsillar and Base of Tongue Squamous Cell Carcinomas Reveals a Global Mutational Pattern along with Relapse-Specific Somatic Variants.
Ährlund-Richter A, Holzhauser S, Dalianis T, Näsman A, et al · · 2021 · cited 7× · PMID 35008243 · DOI 10.3390/cancers14010077
Verify or expand the search:
- PubMed search for NCT04524000
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Alpelisib
Trials testing the same drug.
- NCT06997588 — EPIK-P4: A Phase II Single-arm Study to Assess the Efficacy, Safety and Pharmacokinetics of Alpelisib (BYL719) in Pediat · Phase 2 · recruiting
- NCT05948943 — Alpelisib in Pediatric and Adult Patients With Lymphatic Malformations Associated With a PIK3CA Mutation. · Phase 2, PHASE3 · recruiting
- NCT05967286 — Olaparib and Alpelisib for Treatment of Metastatic Breast Cancer, A ComboMATCH Treatment Trial · Phase 2 · withdrawn
- NCT04967248 — A NIS of Alpelisib in Combination With Fulvestrant in Postmenopausal Women, and Men, With HR+,HER2- , Locally Advanced o · terminated
- NCT05646862 — A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Pa · Phase 3 · active not recruiting
Other recruiting trials for Advanced Breast Cancer
Currently open trials in the same condition.
- NCT07408089 — Study of the Kinesin Oral Molecular Degrader BBI-940 in Subjects With Advanced or Metastatic Breast Cancer · Phase 1 · recruiting
- NCT07318805 — A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors · Phase 1 · recruiting
- NCT07259226 — Optimal Methods to Characterize ADC Resistance in Solid Tumors and Identify Clinically Useful Biomarkers · Phase 2 · recruiting
- NCT06982521 — Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PI · Phase 3 · recruiting
- NCT07428655 — Acceptability and Feasibility of PSC Model of Serious Illness Communication · NA · active not recruiting
Other Novartis Pharmaceuticals trials
Trials by the same sponsor.
- NCT07498335 — Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary · Phase 3 · not yet recruiting
- NCT07489573 — Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa · Phase 4 · not yet recruiting
- NCT07484269 — PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan · not yet recruiting
- NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy · not yet recruiting
- NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+ · Phase 1, PHASE2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04524000 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
- Last refreshed: 8 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04524000.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing