A Non-interventional Study for Women With HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer to Evaluate the Real-world Effectiveness of Treatment Algorithms Beginning With Ribociclib + AI/FUL, or With Endocrine Therapy or Chemotherapy as First Line Treatment (RIBANNA)

Novartis

Status

Completed

Conditions

Breast Cancer

Treatments

Drug: First-line endocrine therapy

Drug: First-line Ribociclib + endocrine therapy

Drug: First-line chemtherapy

Study type

Observational

Funder types

Industry

Identifiers

NCT06311383

CLEE011ADE03

Details and patient eligibility

About

This is a non-interventional observational study conducted in Germany to evaluate the real-world effectiveness, tolerability, safety, and quality of life in patients with locally advanced/metastatic HR+/HER2- breast cancer treated with one of the following 1st line treatments: Ribociclib + AI/FUL, or endocrine monotherapy, or chemotherapy

Full description

This non-interventional study collects data from clinical practice capturing on effectiveness, safety and tolerability, duration of therapy, and quality of life of ribociclib in combination with an aromatase inhibitor/fulvestrant in daily routine and in line with the respective current German summary of product characteristics. In order to put these results into perspective, data is also collected on patients treated with endocrine therapy or chemotherapy for first line locally advanced or metastatic breast cancer. To gain insight into algorithms and outcome of sequential therapy, up to three lines of treatment are documented within this study. The information gathered and evaluated in this NIS is helping to answer open questions for the treatment of locally advanced/metastatic breast cancer and provides first insights into the treatment reality with ribociclib in this setting. This includes, but is not limited to, the questions on baseline demographics leading to a specific treatment decision, as well as efficacy and clinical routine related to treatment sequencing. In addition, data on the mutation status (including PIK3CA and BRCA1/2) is collected at different time points to generate insights into the clinical routine of mutation testing and to understand its impact on therapy sequencing.

Enrollment

2,610 patients

Sex

Female

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with a histological diagnosis of locally advanced/metastatic HR+/HER2- breast cancer. Histological diagnosis does not necessarily origin from metastasis, but must reflect the most recent disease status
No prior systemic treatment for locally advanced/metastatic disease in the palliative setting
The treating physician has made the decision to treat the patient
with ribociclib in combination with an aromatase inhibitor or fulvestrant as initial treatment in first line, or
endocrine therapy as initial treatment in first line (e.g. letrozole, anastrozole, fulvestrant), or
chemotherapy as initial treatment in first line (e.g. taxanes, capecitabine, with or without bevacizumab)
Written informed consent of the patient
Patient who initiated treatment for first line no longer than 4 weeks (28 days) prior to written informed consent for this study
Planned treatment is in line with the respective current German SmPC ("Summary of product characteristics")
Patient is ≥18 years

Exclusion criteria

Patients unable to provide written informed consent
Contra-indication according to the respective current German SmPC ("Summary of product characteristics"), as judged by the treating physician
The patient is currently under active treatment in an investigational study