NCT05022342 (SPEAR) is a clinical trial of alpelisib plus fulvestrant in Breast Cancer, sponsored by Novartis Pharmaceuticals.

Who is sponsoring NCT05022342?

NCT05022342 is sponsored by Novartis Pharmaceuticals.

What drugs are being tested in NCT05022342?

Interventions in NCT05022342: alpelisib plus fulvestrant.

What condition does NCT05022342 study?

NCT05022342 studies Breast Cancer.

Is NCT05022342 still recruiting?

NCT05022342 is currently completed. Last updated 23 February 2026.

Last reviewed 2026-02-23 · How we verify

NCT05022342: SPEAR

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study of PIK3CA Mutations and Effectiveness and Tolerability Outcomes of Alpelisib in Real-world

Completed Last updated 23 February 2026

What this trial tests

trial testing alpelisib plus fulvestrant in Breast Cancer in 595 participants. Completed in 11 February 2025.

Timeline

27 October 2021

Primary endpoint
11 February 2025

11 February 2025

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Status	Completed
Study type	OBSERVATIONAL
Enrollment	595
Start date	27 October 2021
Primary completion	11 February 2025
Estimated completion	11 February 2025
Sites	28 locations across India

Drugs / interventions tested

alpelisib plus fulvestrant

Conditions studied

Breast Cancer — all drugs for Breast Cancer →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

Adults 18 to 100, any sex, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

SPEAR is a non-interventional / observational, prospective, multicenter study planned to be conducted across \~ 30 sites in India, among HR-positive and HER2-negative ABC/MBC patients. This being a non-interventional study, no investigational drug or intervention will be administered as a part of the study participation. All the therapeutic decisions, as well as the type and timing of disease monitoring, laboratory tests or medical procedures will be at the discretion of the treating physician and upon patient's consent. No visits will be scheduled as a part of this non-interventional study, however, data by visits for variables will be collected for all the enrolled patients.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Concomitant <i>PIK3CA</i> and <i>TP53</i> Mutations in Breast Cancer: An Analysis of Clinicopathologic and Mutational Features, Neoadjuvant Therapeutic Response, and Prognosis.
Lin XY, Guo L, Lin X, Wang Y, et al · · 2023 · cited 5× · PMID 37565929 · DOI 10.4048/jbc.2023.26.e30
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:

Other recruiting trials for Breast Cancer

Currently open trials in the same condition.

NCT06148038 — CBD for Breast Cancer Primary Tumors · Phase 1 · recruiting
NCT07405801 — A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus R · Phase 2 · recruiting
NCT07285993 — Detection and Outcomes in Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAP PET · Phase 2 · recruiting
NCT07510698 — Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer · NA · recruiting
NCT06768931 — Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer · 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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05022342 (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: 23 February 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/NCT05022342.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing