A Study of Real-World Outcomes of Ribociclib in First-Line Treatment for Metastatic HR+/HER2- Breast Cancer

Completed

Conditions studied: Metastatic HR+/HER2- Breast Cancer

In brief

The main aim of this study was to describe the profile of hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) metastatic breast cancer (mBC) patients who received first-line (1L) current treatment options with ribociclib in the United States (US) clinical practice. This study used administrative claims data. De-identified patient-level data of adult patients with HR+/HER2- mBC who initiated 1L treatment with a cyclin dependant kinase 4/6 inhibitor (CDK4/6i) i.e., ribociclib from the Komodo Health Solutions Research Database (KRD; data from 1 January 2016 to 30 June 2023) was used. Data included medical and pharmacy claims for insured patients, which had already been collected (i.e., secondary use of data).

Key facts

Study ID

NCT07086196

Run by

Novartis Pharmaceuticals

People needed

350

Starts

2024-05-30

Expected to finish

2024-08-30

Last updated by the study team

2025-07-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Had 1 or more paid pharmacy claims for ribociclib with the first claim for the CDK4/6i observed between 26 February 2018 and 31 December 2022 (i.e., during the index period)
• With the index CDK4/6i used in combination with an endocrine-based therapy, that is an aromatase inhibitor (i.e., letrozole, anastrozole, or exemestane), or fulvestrant, as 1L treatment for mBC
• With the endocrine therapy (ET) initiated within 60 days of the first paid pharmacy claim of the index CDK4/6i; ET may have been initiated no earlier than 60 days prior to the index date (expected window for insurance approval of the CDK4/6i as 1L treatment for mBC in a real-world setting)
• Adult who was 18 years of age or older as of the index date
• Had 2 or more medical service claims with a code for breast cancer (BC) separated by 30 days or more, and 1 or more claims with a code for BC prior to the index date
• Had 2 or more medical service claims with a code for a secondary neoplasm separated by 30 days or more, with the first code for a secondary neoplasm occurring not earlier than 30 days from the first diagnosis for BC, and 1 or more claims with a code for a secondary neoplasm prior to the index date
• Had continuous health plan enrollment for 12 months or more prior to and 1 month or more after the index date

You may not qualify if…

• Patients who did not meet the inclusion criteria
• Had a diagnosis for other primary cancers (other than BC) before the first diagnosis for secondary neoplasm
• Had prior treatments for BC (i.e., chemotherapy, targeted therapy, ET [except ≤60 days prior to index date], or immunotherapy) during the 12-month washout period (relapsed/progressed ≤12 months prior to index date)
• Had prior surgical procedure for BC during the 12-month washout period (relapsed/progressed ≤12 months prior to index date)
• Had evidence of participation in a clinical trial prior to or at the index date (International Classification of Disease, 10th Edition, Clinical Modification [ICD-10-CM]: Z00.6)

Where it is running

• Novartis — East Hanover, New Jersey, United States

Full record on ClinicalTrials.gov

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