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RECRUITINGOBSERVATIONAL

Real-world Evaluation of Patient Outcomes and Experiences With Ribociclib Early Adopters.

Real-world Evaluation of Patient Outcomes and Experiences With Ribociclib Early Adopters: A Hybrid Study With Prospective Patient-reported Outcomes and Retrospective Clinical Chart Review.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This non-interventional study (NIS) aims to evaluate effectiveness, persistence, treatment patterns, adverse events (AEs), and patient-reported experience (including adherence, treatment satisfaction, health-related quality of life \[HRQoL\], work productivity, and etc.), among HR+/HER2- stage II and III eBC patients treated with ribociclib + ET, and to evaluate AEs and patients-reported experience among HR+/HER2- stage II and III eBC patients treated with abemaciclib + ET, as per local label.

Who May Be Eligible (Plain English)

Who May Qualify: - Males or females. - Diagnosed with breast cancer, as defined by the International Classification of Diseases (ICD), 9th or 10th Revision, Clinical Modification (ICD-9-CM 174.xx, 175.xx/ICD-10-CMC50.xx). - Aged ≥18 years (or local legal age of consent) at the date of initial breast cancer diagnosis. - Patients with anatomic staging II and III as determined using American Joint Committee on Cancer (AJCC) Criteria. - Have initiated adjuvant therapy with ribociclib or abemaciclib, per the approved local label, in combination with ET (within 14 days prior to enrollment). - Have HR+ status, as determined by the closest biomarker test on or before the adjuvant therapy initiation date: - Tested positive for estrogen receptor (ER+), or - Tested positive for progesterone receptor (PR+), or - Tested positive for both. - Tested negative for HER2 (HER2-) using the closest biomarker test on or before the adjuvant therapy initiation date. Who Should NOT Join This Trial: - Patients with local or distant breast cancer recurrence before the ribociclib/abemaciclib initiation date. - Patients enrolled in clinical trials (receiving treatment with clinical study drugs in any setting, i.e., neoadjuvant, adjuvant, local/regional, metastatic) during the 12-month baseline period. - Patients physically/mentally incapable of understanding the study requirements or fulfilling data collection instruments and require the support of a legally authorized representative. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Males or females. * Diagnosed with breast cancer, as defined by the International Classification of Diseases (ICD), 9th or 10th Revision, Clinical Modification (ICD-9-CM 174.xx, 175.xx/ICD-10-CMC50.xx). * Aged ≥18 years (or local legal age of consent) at the date of initial breast cancer diagnosis. * Patients with anatomic staging II and III as determined using American Joint Committee on Cancer (AJCC) Criteria. * Have initiated adjuvant therapy with ribociclib or abemaciclib, per the approved local label, in combination with ET (within 14 days prior to enrollment). * Have HR+ status, as determined by the closest biomarker test on or before the adjuvant therapy initiation date: * Tested positive for estrogen receptor (ER+), or * Tested positive for progesterone receptor (PR+), or * Tested positive for both. * Tested negative for HER2 (HER2-) using the closest biomarker test on or before the adjuvant therapy initiation date. Exclusion Criteria: * Patients with local or distant breast cancer recurrence before the ribociclib/abemaciclib initiation date. * Patients enrolled in clinical trials (receiving treatment with clinical study drugs in any setting, i.e., neoadjuvant, adjuvant, local/regional, metastatic) during the 12-month baseline period. * Patients physically/mentally incapable of understanding the study requirements or fulfilling data collection instruments and require the support of a legally authorized representative.

Locations (1)

Novartis Investigative Site
London, United Kingdom