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A Real-World Study of Clinical Adoption, Treatment Patterns and Tolerability of Adjuvant Ribociclib in HR+/HER2- Early Breast Cancer Patients

NCT07710716

Active Not RecruitingN/A

Sponsor: Novartis Pharmaceuticals

Conditions: Breast Cancer

Countries: Switzerland

The aim of this study is to assess the clinical adoption, treatment patterns, and safety of adjuvant ribociclib use in hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (eBC) patients. This is a multi-country study using secondary real-world data sources.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion criteria:

1. Evidence of diagnosis of eBC during the identification period.
2. Aged ≥18 years at index diagnosis date. The index diagnosis date is the date of first diagnosis of eBC.
3. Anatomic stage I-III breast cancer (BC) per American Joint Committee on Cancer (AJCC), 8th Edition at index diagnosis date.
4. Evidence of HR+ during the study period:

   1. have tested positive for estrogen receptor (ER+), or
   2. have tested positive for progesterone receptor (PR+), or
   3. have tested positive for both.
5. Tested negative for HER2 (HER2-) during the study period.
6. Evidence of surgical resection of the primary breast tumor at any time.
7. Received endocrine therapy (ET) in the adjuvant setting after index diagnosis date.

Exclusion criteria:

1. Evidence of another secondary malignancy at any time prior to index diagnosis date.
2. Evidence of other primary cancer (except for skin cancer) at any time prior to index diagnosis date.
3. Patients who participate in an interventional clinical trial at any time prior to or during the study period.
4. Patients with severely incomplete or inconsistent data, precluding validity of results.

Other protocol-defined inclusion/exclusion criteria may apply.

Locations (1)

Basel, Switzerland