Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06152471
Status:
RECRUITING
Last Update Posted:
2023-11-30
First Post:
2023-10-19
Brief Title:
Effect of Salovum and SPC-Flakes on Abemaciclib-induced Gastrointestinal Toxicity in Early Breast Cancer
Sponsor:
Henrik Lindman
Organization:
Uppsala University Hospital
Study Overview
Official Title:
A Randomized Double-blind Placebo Controlled Phase 3 Trial on the Effect of Salovum and SPC-Flakes on Abemaciclib-induced Gastrointestinal Toxicity in Early Breast Cancer - the ASF-BC Study
Status:
RECRUITING
Status Verified Date:
2023-11
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:
ASF-BC
Brief Summary:
The present study aims to investigate a proactive strategy including Salovum and SPC-flakes to prevent the occurrence of abemaciclib-induced diarrhea in patients with early breast cancer
Detailed Description:
In patients with high-risk luminal breast cancer the addition of CDK 46-inhibitor abemaciclib to adjuvant endocrine therapy for two years has been associated with improved disease-free survival and is now recommended from national and international guidelines as the preferred treatment strategy for this patient group However patients treated with abemaciclib have higher risk of diarrhea which primarily occurs during the first three months from treatment initiation and seems to impact patients quality of life As a result early and proactive strategies to reduce the occurrence of diarrhea from the initiation of abemaciclib should be investigated to ensure that patients in whom adjuvant abemaciclib is recommended can complete their treatment as planned
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None