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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Early-stage Breast Cancer, Diarrhea, Adverse Drug Event

Intervention / Treatment
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* Drug: SPC-flakes
* Drug: Salovum
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomization 1:1 to investigational product or placebo
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Salovum egg powder high in antisecretory factor, 4 g/sachet. Four sachets, ie 16 gr q 8 hours for 6 days before start of abemaciclib SPC-flakes flat dose 75gr/day in parallel and during first 12 weeks of treatment with abemaciclib | Drug: SPC-flakes<br>* Aktive drug<br>Drug: Salovum<br>* Active drug<br>|
| Placebo Comparator: Placebo Comparator<br>Placebo, identical to investigational product but without antisecretory factor. | Drug: Placebo<br>* Placebo drugs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of abemaciclib induced diarrhea - CTCAE | Occurrence of any-grade diarrhea according to CTCAE v. 5.0 | Three months | 
| QoL using FACT-B | The tool is FACT-B | Three months | 
| QoL using FACT-GP5 | The tool is FACT-GP5 | Three months | 
| QoL using FACIT-D | The tool is FACIT-D | Three months | 
| 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 | 
| 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 | 
| 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 | 
| Sick leave | Sick leave duration | Two years | 
| Breast cancer recurrence | Breast cancer recurrence | Two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Early Breast cancer, Abemaciclib induced diarrea