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

Diarrhea Clinical Trial

— ASF-BC  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06152471
• Other study ID #: Version 1.3, 30May2022
• Status: Recruiting
• Phase: Phase 3
• Start date: June 7, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: November 2023
• Source: Uppsala University Hospital
• Contact: Maria Larsson
• Phone: +46 18 611 39 45
• Email: maria.b.larsson[@]akademiska.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 31, 2025
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adverse Drug Event
• Breast Neoplasms
• Diarrhea
• Drug-Related Side Effects and Adverse Reactions
• Early-stage Breast Cancer

Intervention

Drug:
• SPC-flakes
Aktive drug
• Salovum
Active drug
• Placebo
Placebo drugs

Locations

Country	Name	City	State
Sweden	General Hospital of Eskilstuna	Eskilstuna
Sweden	General Hospital of Falun	Falun
Sweden	General Hospital of Gävle	Gävle
Sweden	University Hospital Örebro	Örebro
Sweden	General Hospital	Sundsvall
Sweden	Uppsala University Hospital	Uppsala
Sweden	General Hospital Västerås	Västerås

Sponsors (1)

Lead Sponsor	Collaborator
Henrik Lindman

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of Abemaciclib induced diarrhea - STIDAT	? Occurrence of any-grade (mild, moderate, severe) diarrhea according to the Systemic Treatment-Induced Diarrhea Assessment Tool (STIDAT; patient-reported outcome).	Three months
Secondary	Occurrence of abemaciclib induced diarrhea - CTCAE	Occurrence of any-grade diarrhea according to CTCAE v. 5.0	Three months
Secondary	QoL using FACT-B	The tool is FACT-B	Three months
Secondary	QoL using FACT-GP5	The tool is FACT-GP5	Three months
Secondary	QoL using FACIT-D	The tool is FACIT-D	Three months
Secondary	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] besides diarrhea.	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, besides diarrhea.	Three months
Secondary	Rate of patients that stop or interrupt treatment with investigational products	Rate of patients that stop or interrupt treatment with Salovum and SPC-flakes/placebo during planned study time.	Three months
Secondary	Rate of patients that stop or interrupt treatment with abemaciclib	Rate of patients that stop or interrupt treatment with abemaciclib during the planned treatment time of two years.	Two years
Secondary	Sick leave	Sick leave duration	Two years
Secondary	Breast cancer recurrence	Breast cancer recurrence	Two years