Status:
UNKNOWN
Effect of Salovum™ and SPC-Flakes™ on Abemaciclib-induced Gastrointestinal Toxicity in Early Breast Cancer
Lead Sponsor:
Henrik Lindman
Conditions:
Early-stage Breast Cancer
Diarrhea
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 4/6-inhibitor abemaciclib to adjuvant endocrine therapy for two years has been associated with improved disease-free survival and ...
Eligibility Criteria
Inclusion
- Age ≥ 18 years.
- Histologically confirmed diagnosis of luminal breast cancer.
- No clinical evidence of metastatic disease.
- Planned to start abemaciclib in adjuvant setting (according to current national guidelines).
- Signed informed consent.
Exclusion
- Contraindications to the investigational product, e g known or suspected hypersensitivity to the investigational products or expected inability to their use in accordance with the protocol.
- Lack of suitability for participation in the study, e g expected difficulties to follow the protocol procedures, as judged by the investigator.
- Prior exposure to abemaciclib.
- Prior exposure to Salovum or SPC-flakes.
- Past or present history of inflammatory bowel disease.
Key Trial Info
Start Date :
June 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06152471
Start Date
June 7 2023
End Date
March 31 2025
Last Update
November 30 2023
Active Locations (7)
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1
General Hospital of Eskilstuna
Eskilstuna, Sweden, 631 88
2
General Hospital of Falun
Falun, Sweden, 791 82
3
General Hospital of Gävle
Gävle, Sweden, 801 87
4
University Hospital Örebro
Örebro, Sweden, 701 85