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Completed

NCT Number: 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

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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Key information

Conditions

HR+/HER2- Advanced or Metastatic Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Pharmaceuticals

Dublin, Ireland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Overall survival (OS)

    Time frame: 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.

  2. Real-world progression-free survival (rwPFS)

    Time frame: 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.

  3. Line of treatment of ALP+FUL received

    Time frame: Baseline

  4. Line of treatment number of index regimens stratified by index year

    Time frame: Baseline

  5. Starting dose of alpelisib

    Time frame: Baseline

  6. Number of prior regimens

    Time frame: Baseline

  7. Prior fulvestrant treatment category

    Time frame: Baseline

  8. Prior regimens of patients who received alpelisib plus fulvestrant as first-line treatment

    Time frame: Baseline

  9. Number of prior fulvestrant regimens prior to alpelisib plus fulvestrant

    Time frame: Baseline

  10. Percentage of patients with prior exposure to CDK4/6i in the adjuvant setting

    Time frame: Baseline

  11. Percentage of patients with prior exposure to chemotherapy in the metastatic setting

    Time frame: Baseline

  12. Time to treatment discontinuation

    Time frame: Up to approximately 21 months

  13. First antineoplastic regimen received after discontinuation of the alpelisib plus fulvestrant regimen

    Time frame: Up to approximately 21 months

Secondary outcomes

  1. Overall survival (OS) in subgroups of patients according to the prior lines of treatment

    Time frame: 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.

  2. Real-world progression-free survival (rwPFS) in subgroups of patients according to the prior lines of treatment

    Time frame: 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.

  3. Line of treatment of ALP+FUL received in subgroups of patients according to the prior lines of treatment

    Time frame: Baseline

  4. Line of treatment number of index regimens stratified by index year in subgroups of patients according to the prior lines of treatment

    Time frame: Baseline

  5. Starting dose of alpelisib in subgroups of patients according to the prior lines of treatment

    Time frame: Baseline

  6. Number of prior regimens in subgroups of patients according to the prior lines of treatment

    Time frame: Baseline

  7. Prior fulvestrant treatment category in subgroups of patients according to the prior lines of treatment

    Time frame: Baseline

  8. Prior regimens of patients who received alpelisib plus fulvestrant as first-line treatment in subgroups of patients according to the prior lines of treatment

    Time frame: Baseline

  9. Number of prior fulvestrant regimens prior to alpelisib plus fulvestrant in subgroups of patients according to the prior lines of treatment

    Time frame: Baseline

  10. Percentage of patients with prior exposure to CDK4/6i in the adjuvant setting in subgroups of patients according to the prior lines of treatment

    Time frame: Baseline

  11. Percentage of patients with prior exposure to chemotherapy in the metastatic setting in subgroups of patients according to the prior lines of treatment

    Time frame: Baseline

  12. Time to treatment discontinuation in subgroups of patients according to the prior lines of treatment

    Time frame: Up to approximately 21 months

  13. First antineoplastic regimen received after discontinuation of the alpelisib plus fulvestrant regimen in subgroups of patients according to the prior lines of treatment

    Time frame: Up to approximately 21 months

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 10, 2023
Registry last updated
May 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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