A Real-world Study of Effectiveness and Safety in HR+/HER2- Breast Cancer Patients Treated With Ribociclib or Alpelisib

NCT06705504 | Completed

• 1 other identifier: CLEE011A3002
• Study Type: observational
• Target: 435
• Locations: 1 country
• Sites: 1

Brief Summary

This study was a multinational and multicenter cohort study of patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer (aBC/mBC) treated with ribociclib or alpelisib between the period of 01 January 2018 and 30 September 2021. Patients who were receiving active treatment for malignancies other than BC or participating in a clinical trial were excluded. This study was conducted retrospectively with secondary use of data.

Conditions

Hormone Receptor Positive HER-2 Negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Real-world Progression-free Survival (rwPFS)

  rwPFS was defined as the time from the index date to the date of the first documented progression or death due to any cause. If a patient did not have an event, rwPFS was censored at the date of the last adequate tumor assessment. The index date was defined as the date of the first treatment with ribociclib or alpelisib.

  Up to 51 months

Secondary Outcomes (31)

• Age

  Baseline

• Number of Patients by Age Group

  Baseline

• Gender

  Baseline

• Number of Patients Categorized by Year of Index Date

  Baseline

• Number of Patients With a History of Breast Cancer

  Baseline

Study Arms (4)

Institut de Cancérologie de l'Ouest (ICO) Cohort

Patients with HR+/HER2- advanced or metastatic BC who were registered in IQVIA's oncology evidence network (OEN), ICO, and initiated treatment with ribociclib or alpelisib.

L'Institut Curie (Curie) Cohort

Patients with HR+/HER2- advanced or metastatic BC who were registered in IQVIA's OEN, Curie, and initiated treatment with ribociclib or alpelisib.

Instituto Português de Oncologia do Porto (IPO-Porto) Cohort

Patients with HR+/HER2- advanced or metastatic BC who were registered in IQVIA's OEN, IPO-Porto, and initiated treatment with ribociclib or alpelisib.

Czech Republic Cohort

Patients with HR+/HER2- advanced or metastatic BC who were registered in Czech Republic local sites or clinics proposed by Novartis affiliates and initiated treatment with ribociclib or alpelisib.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study.

You may qualify if:

• Confirmed diagnosis of locally advanced/metastatic not amenable to surgery HR+/HER2- BC (progressed following prior therapy or de novo) for whom the treating physician took the decision to initiate treatment with ribociclib or alpelisib.
• Patients with at least one prescription for ribociclib or alpelisib during the index period (01 January 2018 to 30 September 2021).

You may not qualify if:

• Patients who were participating in any interventional clinical trial that included investigational or marketed products at the time of index (ribociclib, alpelisib, and other); patients who were participating in other investigator-initiated research or non-interventional study (NIS) could be included as long as their standard of care was not altered by the study.
• Patients on active treatment for malignancies other than HR+/HER2- aBC/mBC at the time of index.
• IPO-Porto cohort only:
• Patients who had participated or were participating in any interventional clinical trial that included investigational or marketed products at the time of index (ribociclib, alpelisib, and others).
• Patients who underwent part of the treatment for locally advanced/metastatic not amenable to surgery HR+/HER2- BC outside the center.

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

Novartis

East Hanover, New Jersey, 07936, United States

Location

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: November 26, 2024
• Study Start: June 11, 2021
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: November 26, 2024

Record last verified: 2024-11

Locations

US (1)