Clinical trial NCT05853432: 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
Official title: 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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HR+/HER2- Advanced or Metastatic Breast Cancer
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2023-05-10
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This was a retrospective, noninterventional cohort study

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Overall survival (OS)
timeFrame: Up to approximately 21 months
measure: Real-world progression-free survival (rwPFS)
timeFrame: Up to approximately 21 months
measure: Line of treatment of ALP+FUL received
timeFrame: Baseline
measure: Line of treatment number of index regimens stratified by index year
timeFrame: Baseline
measure: Starting dose of alpelisib
timeFrame: Baseline
measure: Number of prior regimens
timeFrame: Baseline
measure: Prior fulvestrant treatment category
timeFrame: Baseline
measure: Prior regimens of patients who received alpelisib plus fulvestrant as first-line treatment
timeFrame: Baseline
measure: Number of prior fulvestrant regimens prior to alpelisib plus fulvestrant
timeFrame: Baseline
measure: Percentage of patients with prior exposure to CDK4/6i in the adjuvant setting
timeFrame: Baseline
measure: Percentage of patients with prior exposure to chemotherapy in the metastatic setting
timeFrame: Baseline
measure: Time to treatment discontinuation
timeFrame: Up to approximately 21 months
measure: First antineoplastic regimen received after discontinuation of the alpelisib plus fulvestrant regimen
timeFrame: Up to approximately 21 months
Secondary outcomes:
measure: Overall survival (OS) in subgroups of patients according to the prior lines of treatment
timeFrame: Up to approximately 21 months
measure: Real-world progression-free survival (rwPFS) in subgroups of patients according to the prior lines of treatment
timeFrame: Up to approximately 21 months
measure: Line of treatment of ALP+FUL received in subgroups of patients according to the prior lines of treatment
timeFrame: Baseline
measure: Line of treatment number of index regimens stratified by index year in subgroups of patients according to the prior lines of treatment
timeFrame: Baseline
measure: Starting dose of alpelisib in subgroups of patients according to the prior lines of treatment
timeFrame: Baseline
measure: Number of prior regimens in subgroups of patients according to the prior lines of treatment
timeFrame: Baseline
measure: Prior fulvestrant treatment category in subgroups of patients according to the prior lines of treatment
timeFrame: Baseline
measure: Prior regimens of patients who received alpelisib plus fulvestrant as first-line treatment in subgroups of patients according to the prior lines of treatment
timeFrame: Baseline
measure: Number of prior fulvestrant regimens prior to alpelisib plus fulvestrant in subgroups of patients according to the prior lines of treatment
timeFrame: Baseline
measure: Percentage of patients with prior exposure to CDK4/6i in the adjuvant setting in subgroups of patients according to the prior lines of treatment
timeFrame: Baseline
measure: Percentage of patients with prior exposure to chemotherapy in the metastatic setting in subgroups of patients according to the prior lines of treatment
timeFrame: Baseline
measure: Time to treatment discontinuation in subgroups of patients according to the prior lines of treatment
timeFrame: Up to approximately 21 months
measure: First antineoplastic regimen received after discontinuation of the alpelisib plus fulvestrant regimen in subgroups of patients according to the prior lines of treatment
timeFrame: Up to approximately 21 months
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Novartis Pharmaceuticals
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: