Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06311383
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-08
First Post:
2023-12-29
Brief Title:
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 AIFUL or With Endocrine Therapy or Chemotherapy as First Line Treatment
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
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 Kisqali Ribociclib in Combination With an Aromatase InhibitorFulvestrant or With Endocrine Therapy or Chemotherapy as First Line Treatment
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RIBANNA
Brief Summary:
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 advancedmetastatic HRHER2- breast cancer treated with one of the following 1st line treatments Ribociclib AIFUL or endocrine monotherapy or chemotherapy
Detailed 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 inhibitorfulvestrant 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 advancedmetastatic 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 BRCA12 is collected at different time points to generate insights into the clinical routine of mutation testing and to understand its impact on therapy sequencing
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None