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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

435 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-11

Study Completion Date

2023-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Hormone Receptor Positive HER-2 Negative Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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).

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No