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
- HR+/HER2- Advanced or Metastatic Breast Cancer
- Registration Number
- NCT05853432
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 157
- 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.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Real-world progression-free survival (rwPFS) Up to approximately 21 months 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.
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 fulvestrant regimens prior to alpelisib plus fulvestrant Baseline Percentage of patients with prior exposure to chemotherapy in the metastatic setting Baseline Prior fulvestrant treatment category Baseline Prior regimens of patients who received alpelisib plus fulvestrant as first-line treatment Baseline Percentage of patients with prior exposure to CDK4/6i in the adjuvant 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 Number of prior regimens Baseline Overall survival (OS) Up to approximately 21 months 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.
- Secondary Outcome Measures
Name Time Method Percentage of patients with prior exposure to chemotherapy in the metastatic setting in subgroups of patients according to the prior lines of treatment Baseline Real-world progression-free survival (rwPFS) in subgroups of patients according to the prior lines of treatment Up to approximately 21 months 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.
Overall survival (OS) in subgroups of patients according to the prior lines of treatment Up to approximately 21 months 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.
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 Line of treatment of ALP+FUL received 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 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 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 Number of prior regimens 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
Trial Locations
- Locations (1)
Novartis Pharmaceuticals
🇮🇪Dublin, Ireland