Effect of Salovum™ and SPC-Flakes™ on Abemaciclib-induced Gastrointestinal Toxicity in Early Breast Cancer

• Status: Recruiting
• Trial end date: 2025-03-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Henrik Lindman

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.