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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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HR+/HER2- Advanced or Metastatic Breast Cancer

Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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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 |