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

NCT04967248 | Terminated

• 1 other identifier: CBYL719C2404
• Study Type: observational
• Target: 4
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hormone Receptor Positive HER2 Negative Breast Cancer With a PIK3CA Mutation

Keywords

Breast Cancer; non-interventional study; NIS; alpelisib; fulvestrant; PASS

Outcome Measures

Primary Outcomes (1)

• Incidence proportion of hyperglycemia

  To assess the incidence of hyperglycemia (Adverse Event of Special Iinterest) observed during follow-up of patients treated with alpelisib in combination with fulvestrant.

  Up to 53 months

Secondary Outcomes (10)

• Calculated BMI

  Baseline

• Medical history

  Baseline

• Family history of diabetes mellitus

  Baseline

• Number of patients with concomitant medications known to affect blood glucose levels

  Baseline

• Number of participants with incidence proportion of ketoacidosis and Hyperglycemic Hyperosmolar Non-Ketotic Syndrome (HHNKS)

  Up to 53 months

Study Arms (1)

alpelisib in combination with fulvestrant

Patients treated with alpelisib in combination with fulvestrant

Other: Alpelisib; Other: Fulvestrant

Interventions

Alpelisib OTHER

Prospective observational PASS study. There was no treatment allocation. Patients recruited on or before their first prescribed dose of alpelisib in combination with fulvestrant were enrolled.

alpelisib in combination with fulvestrant

Fulvestrant OTHER

Prospective observational PASS study. There was no treatment allocation. Patients recruited on or before their first prescribed dose of alpelisib in combination with fulvestrant were enrolled.

alpelisib in combination with fulvestrant

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Postmenopausal women, and adult men, with HR+, HER2- locally advanced or metastatic breast cancer whose tumor harbors a PIK3CA mutation, and who were treated with alpelisib in combination with fulvestrant after disease progression following endocrine therapy as monotherapy, in the real-world setting.

You may qualify if:

• Signed informed consent from the patient or a legally acceptable representative, obtained before any study-related activities are undertaken
• Patients diagnosed with HR+, HER2- locally advanced or metastatic breast cancer with a PIK3CA mutation
• Patients who have disease progression following endocrine therapy as monotherapy
• Patients must be postmenopausal women, or men, ≥18 years of age
• Patients recruited on or before their first prescribed dose of alpelisib in combination with fulvestrant

You may not qualify if:

• Use of alpelisib prior to signing the informed consent form for this study
• Participation in an interventional study within 30 days prior to the initiation of alpelisib

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Related Links

• Link to study results

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Alpelisib; Fulvestrant

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2021
• First Posted: July 19, 2021
• Study Start: June 21, 2023
• Primary Completion: October 18, 2024
• Study Completion: October 18, 2024
• Last Updated: December 4, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share