Clinical trial NCT06152471: Effect of Salovum™ and SPC-Flakes™ on Abemaciclib-induced Gastrointestinal Toxicity in Early Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Early-stage Breast Cancer
Diarrhea
Adverse Drug Event
Keywords: Early Breast cancer
Abemaciclib induced diarrea
Lead sponsor: Uppsala University Hospital
Sponsor class: OTHER
First posted: 2023-11-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization 1:1 to investigational product or placebo
Primary purpose: TREATMENT

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 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.

Eligibility 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.

Primary outcomes:
measure: Occurrence of Abemaciclib induced diarrhea - STIDAT
timeFrame: Three months
Secondary outcomes:
measure: Occurrence of abemaciclib induced diarrhea - CTCAE
timeFrame: Three months
measure: QoL using FACT-B
timeFrame: Three months
measure: QoL using FACT-GP5
timeFrame: Three months
measure: QoL using FACIT-D
timeFrame: Three months
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] besides diarrhea.
timeFrame: Three months
measure: Rate of patients that stop or interrupt treatment with investigational products
timeFrame: Three months
measure: Rate of patients that stop or interrupt treatment with abemaciclib
timeFrame: Two years
measure: Sick leave
timeFrame: Two years
measure: Breast cancer recurrence
timeFrame: Two years
Other outcomes:
Locations:
city: Eskilstuna
country: Sweden
facility: General Hospital of Eskilstuna
city: Falun
country: Sweden
facility: General Hospital of Falun
city: Gävle
country: Sweden
facility: General Hospital of Gävle
city: Sundsvall
country: Sweden
facility: General Hospital
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
city: Västerås
country: Sweden
facility: General Hospital Västerås
city: Örebro
country: Sweden
facility: University Hospital Örebro
Study officials:
affiliation: Uppsala University Hospital
name: Henrik Lindman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: