Kisqali Access Registry for Metastatic Breast Cancer in Australia

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12619001138178

Acronym

KARMA

Enrollment

Registered

2019-08-15

Start date

2019-07-25

Completion date

2019-12-31

Last updated

2019-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The primary objective of the study is to describe real world clinical and tumour characteristics of patients with HR+ HER2–ve MBC in Australia who have received ribociclib in combination with an AI as part of the ribociclib MAP and/or SPARK access program, and treatment details of AI + ribociclib. Who is it for? You may be eligible to join this study if you are aged 18 years or above, and have been diagnosed with metastatic or advanced HR positive, HER2 –ve breast cancer, for which you have received combination treatment with ribociclib and an aromatase inhibitor as part of the Novartis ribociclib MAP/SPARK program between the period of 1 May 2017 to 30 June 2018. Study Details The information will be collected from the medical records of patients who were prescribed ribociclib in combination with an aromatase inhibitor as part of the ribociclib MAP and/or SPARK access program. We hope that this information will give is an opportunity to improve our understanding of real world ribociclib treatment in Australia.

Interventions

This is a secondary data use non interventional study of patients with hormone receptor positive HER2 negative metatstatic breast cancer who received treatment with the combination of ribociclib and an aromatase inhibitor. The ribociclib was obtained through either the MAP or SPARK program and the data will be retrieved by chart review. Patients data will be collected at 2 timepoints, first between July and September 2019 and then again 12 months later

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Patients who meet the following inclusion criteria are eligible for the study: • Age is 18 or over • Patients with metastatic or advanced HR positive, HER2 –ve breast cancer who have received combination treatment with ribociclib and an aromatase inhibitor as part of the Novartis ribociclib MAP/SPARK program between the period of 1 May 2017 to 30 June 2018

Exclusion criteria

Patients who have opted out of data collection will be excluded from the study.

Outcome results