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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.
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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This was a retrospective, noninterventional cohort study
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Pharmaceuticals | Dublin | Ireland |
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| 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 |
| 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 |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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