Adverse Drug Event, Diarrhea, Early-stage Breast Cancer
Conditions
Keywords
Early Breast cancer, Abemaciclib induced diarrea
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.
Interventions
Sponsors
Henrik Lindman
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
double-blind, placebo controlled
Intervention model description
Randomization 1:1 to investigational product or placebo
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Abemaciclib induced diarrhea - STIDAT | Three months | ● Occurrence of any-grade (mild, moderate, severe) diarrhea according to the Systemic Treatment-Induced Diarrhea Assessment Tool (STIDAT; patient-reported outcome). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of abemaciclib induced diarrhea - CTCAE | Three months | Occurrence of any-grade diarrhea according to CTCAE v. 5.0 |
| QoL using FACT-B | Three months | The tool is FACT-B |
| QoL using FACT-GP5 | Three months | The tool is FACT-GP5 |
| QoL using FACIT-D | Three months | The tool is FACIT-D |
| Rate of patients that stop or interrupt treatment with investigational products | Three months | Rate of patients that stop or interrupt treatment with Salovum and SPC-flakes/placebo during planned study time. |
| Rate of patients that stop or interrupt treatment with abemaciclib | Two years | Rate of patients that stop or interrupt treatment with abemaciclib during the planned treatment time of two years. |
| Sick leave | Two years | Sick leave duration |
| Breast cancer recurrence | Two years | Breast cancer recurrence |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] besides diarrhea. | Three months | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, besides diarrhea. |
Countries
Sweden
Contacts
Primary ContactMaria Larsson
Outcome results
None listed