A Descriptive Study of Baseline Characteristics, Clinical Outcomes, and Treatment Patterns of HR+/HER2- Advanced or Metastatic Breast Cancer Patients Treated With Alpelisib Plus Fulvestrant Who Have Received Fulvestrant in Any Prior Line of Therapy

This was a non-interventional, retrospective cohort study of patients with HR+/HER2- aBC treated with alpelisib (ALP) plus fulvestrant (FUL) who have received fulvestrant in any prior line of therapy (LoT). This study utilized de-identified individual patient data from the United States (US) ConcertAI Patient360 Breast Cancer database, sourced from electronic health records (EHR) (i.e., secondary use of data). Patients were indexed at their start date of the earliest alpelisib plus fulvestrant regimen and followed until their death date or last confirmed activity date in the absence of an observed death.

Study Overview

• Status: Completed
• Conditions: HR+/HER2- Advanced or Metastatic Breast Cancer

• Study Type: Observational
• Enrollment (Actual): 157

Contacts and Locations

Study Locations

• Ireland
  • Dublin, Ireland
    • Novartis Pharmaceuticals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study

Description

Inclusion Criteria:

• Had a curated record for advanced or metastatic breast cancer diagnosis.
• Note: Diagnosis of a/mBC is based on a curated record of M stage=M1, Stage 4/4a/4b, presence of metastatic tumor, Stage 3b/3c or presence of secondary neoplasm.
• Had patient activity documented in ConcertAI Patient 360 Breast Cancer database (defined as a record of a clinic visit, medication administration, vital test, or lab test) or death within 90 days after the advanced or metastatic breast cancer diagnosis date.
• Had documented receipt of treatment with alpelisib plus fulvestrant on or after the advanced or metastatic diagnosis date.
• Had documented receipt of treatment with fulvestrant before the index date (start date of the earliest alpelisib plus fulvestrant regimen). This included (neo) adjuvant therapies.
• Age ≥18 years on the index date.

Exclusion Criteria:

• Had documented hormone receptor-negative (defined as both estrogen receptor-negative and progesterone receptor-negative) or HER2-positive status any time prior to index date (but prioritizing results closest to index date, if there were conflicting results).
• Patient had a clinical trial registration date (i.e., participated in a clinical trial) on or before the index date.
• Patients with "negative" PIK3CA test before index date (in case of multiple tests, the one closer to the index date was used).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS)	OS was defined as the length of time from the start date of the earliest alpelisib plus fulvestrant regimen to the date of death, or last confirmed activity date in the absence of an observed death event.	Up to approximately 21 months
Real-world progression-free survival (rwPFS)	rwPFS was defined as the length of time from the start date of the earliest alpelisib plus fulvestrant regimen to the first documented progression or death date occurring at least 14 days after the index date, or last adequate tumor assessment date in the absence of an observed progression or death event.	Up to approximately 21 months
Line of treatment of ALP+FUL received		Baseline
Line of treatment number of index regimens stratified by index year		Baseline
Starting dose of alpelisib		Baseline
Number of prior regimens		Baseline
Prior fulvestrant treatment category		Baseline
Prior regimens of patients who received alpelisib plus fulvestrant as first-line treatment		Baseline
Number of prior fulvestrant regimens prior to alpelisib plus fulvestrant		Baseline
Percentage of patients with prior exposure to CDK4/6i in the adjuvant setting		Baseline
Percentage of patients with prior exposure to chemotherapy in the metastatic setting		Baseline
Time to treatment discontinuation		Up to approximately 21 months
First antineoplastic regimen received after discontinuation of the alpelisib plus fulvestrant regimen		Up to approximately 21 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS) in subgroups of patients according to the prior lines of treatment	OS was defined as the length of time from the start date of the earliest alpelisib plus fulvestrant regimen to the date of death, or last confirmed activity date in the absence of an observed death event.	Up to approximately 21 months
Real-world progression-free survival (rwPFS) in subgroups of patients according to the prior lines of treatment	rwPFS was defined as the length of time from the start date of the earliest alpelisib plus fulvestrant regimen to the first documented progression or death date occurring at least 14 days after the index date, or last adequate tumor assessment date in the absence of an observed progression or death event.	Up to approximately 21 months
Line of treatment of ALP+FUL received in subgroups of patients according to the prior lines of treatment		Baseline
Line of treatment number of index regimens stratified by index year in subgroups of patients according to the prior lines of treatment		Baseline
Starting dose of alpelisib in subgroups of patients according to the prior lines of treatment		Baseline
Number of prior regimens in subgroups of patients according to the prior lines of treatment		Baseline
Prior fulvestrant treatment category in subgroups of patients according to the prior lines of treatment		Baseline
Prior regimens of patients who received alpelisib plus fulvestrant as first-line treatment in subgroups of patients according to the prior lines of treatment		Baseline
Number of prior fulvestrant regimens prior to alpelisib plus fulvestrant in subgroups of patients according to the prior lines of treatment		Baseline
Percentage of patients with prior exposure to CDK4/6i in the adjuvant setting in subgroups of patients according to the prior lines of treatment		Baseline
Percentage of patients with prior exposure to chemotherapy in the metastatic setting in subgroups of patients according to the prior lines of treatment		Baseline
Time to treatment discontinuation in subgroups of patients according to the prior lines of treatment		Up to approximately 21 months
First antineoplastic regimen received after discontinuation of the alpelisib plus fulvestrant regimen in subgroups of patients according to the prior lines of treatment		Up to approximately 21 months

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2022
• Primary Completion (Actual): May 2, 2022
• Study Completion (Actual): May 2, 2022

Study Registration Dates

• First Submitted: May 2, 2023
• First Submitted That Met QC Criteria: May 2, 2023
• First Posted (Actual): May 10, 2023

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 2, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: CBYL719C2009