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

NCT05022342 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 595

Last updated 2026-02-23

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

alpelisib plus fulvestrant

Prospective observational study. There is no treatment allocation. Patients administered alpelisib plus fulvestrant, that have started before inclusion of the patient into the study will be enrolled.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-27
Primary Completion
2025-02-11
Completion
2025-02-11

Countries

  • India

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05022342 on ClinicalTrials.gov