Last reviewed · How we verify
NCT04967248
A NIS of Alpelisib in Combination With Fulvestrant in Postmenopausal Women, and Men, With HR+,HER2- , Locally Advanced or Metastatic Breast Cancer With a PIK3CA Mutation, After Disease Progression Following Endocrine Therapy as Monotherapy, in the Real-world Setting
trial testing Alpelisib in Hormone Receptor Positive HER2 Negative Breast Cancer With a PIK3CA Mutation in 4 participants. Terminated before completion.
18 October 2024
Quick facts
| Lead sponsor | Novartis Pharmaceuticals |
|---|---|
| Status | Terminated |
| Study type | OBSERVATIONAL |
| Enrollment | 4 |
| Start date | 21 June 2023 |
| Primary completion | 18 October 2024 |
| Estimated completion | 18 October 2024 |
Drugs / interventions tested
- Alpelisib (alpelisib) — full drug profile →
- Fulvestrant (fulvestrant) — full drug profile →
Conditions studied
- Hormone Receptor Positive HER2 Negative Breast Cancer With a PIK3CA Mutation — all drugs for Hormone Receptor Positive HER2 Negative Breast Cancer With a PIK3CA Mutation →
Sponsor
Novartis Pharmaceuticals — full company profile →
Who can join
Adults 18 to 100, any sex, with Hormone Receptor Positive HER2 Negative Breast Cancer With a PIK3CA Mutation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This was a prospective, multi-national, non-interventional study (NIS) collecting data from postmenopausal women, and adult men, with HR+, HER2- locally advanced or metastatic breast cancer whose tumor harbors a PIK3CA mutation, and who were to be treated with alpelisib in combination with fulvestrant after disease progression following endocrine therapy as monotherapy, in the real-world setting.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Molecular Basis of Oncogenic PI3K Proteins.
Sheng Z, Beck P, Gabby M, Habte-Mariam S, et al · · 2024 · cited 1× · PMID 39796708 · DOI 10.3390/cancers17010077
Verify or expand the search:
- PubMed search for NCT04967248
- 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
- NCT05646862 — A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Pa · Phase 3 · active not recruiting
- NCT05564377 — Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The Co · Phase 2 · 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 NCT04967248 (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: 4 December 2025
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/NCT04967248.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing