Early-stage Breast CancerPhase 3ASF-BCNCT06152471
Effect of Salovum™ and SPC-Flakes™ on Abemaciclib-induced Gastrointestinal Toxicity in Early Breast Cancer
A Phase 3 study testing SPC-flakes and Salovum in people with Early-stage Breast Cancer and Diarrhea, run by Henrik Lindman at 7 sites in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Early-stage Breast Cancer, Diarrhea, Adverse Drug Event
- What is being tested?
- SPC-flakes and Salovum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 7 sitesSweden
- Study dates
- 7 Jun 2023to 31 Mar 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Sweden7 sites, 7 recruiting
- Recruiting
General Hospital of Eskilstuna
Eskilstuna, 631 88
Andreas Nearchou, MD, andreas.nearchou@regionsormland.se
- Recruiting
General Hospital of Falun
Falun, 791 82
Greger Nilsson, MD, PhD, greger.nilsson@igp.uu.se
- Not yet recruiting
General Hospital of Gävle
Gävle, 801 87
Olga Del Val Muñoz, MD, olga.del.val.munoz@regiongavleborg.se
- Recruiting
University Hospital Örebro
Örebro, 701 85
Antonis Valachis, MD, PhD, antonios.valachis@oru.se
- Not yet recruiting
General Hospital
Sundsvall, 856 43
Anna-Karin Wennstig, MD, PhD, anna-karin.wennstig@rvn.se
- Recruiting
Uppsala University Hospital
Uppsala, 751 85
Henrik Lindman, MD, PhD, henrik.lindman@akademiska.se
- Recruiting
General Hospital Västerås
Västerås, 721 89
Cecilia Nilsson, MD, PhD, Cecilia.nilsson@regionvastmanland.se
About this study
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
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.
Read the 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.
- Conditions
- Early-stage Breast Cancer, Diarrhea, Adverse Drug Event
- Being tested
- SPC-flakes, Salovum, Placebo
- Keywords
- Early Breast cancer, Abemaciclib induced diarrea
- Medical subject headings
- Breast Neoplasms, Diarrhea, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPC-flakesDrug
Aktive drug
SalovumDrug
Active drug
PlaceboDrug
Placebo drugs
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | 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 Receives: Drug: SPC-flakes; Drug: Salovum |
| Placebo Comparator | Placebo comparator | Placebo, identical to investigational product but without antisecretory factor. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Three months
Secondary outcomes (9)
Occurrence of abemaciclib induced diarrhea - CTCAE
Occurrence of any-grade diarrhea according to CTCAE v. 5.0
Measured: Three months
QoL using FACT-B
The tool is FACT-B
Measured: Three months
QoL using FACT-GP5
The tool is FACT-GP5
Measured: Three months
QoL using FACIT-D
The tool is FACIT-D
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Two years
Sick leave
Sick leave duration
Measured: Two years
Breast cancer recurrence
Breast cancer recurrence
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start7 Jun 2023
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early-stage Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization 1:1 to investigational product or placebo
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henrik Lindman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Henrik Lindman, Uppsala University Hospital
- Investigators
- Henrik Lindman, MD, PhD, Principal investigator, Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06152471
- Sponsor's protocol ID
- Version 1.3, 30May2022
- Acronym
- ASF-BC
- Status last verified
- Nov 2023
- First submitted
- 19 Oct 2023
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06152471
- Acronym / sponsor ID
- ASF-BC / Version 1.3, 30May2022
- Conditions
- Early-stage Breast Cancer, Diarrhea, Adverse Drug Event
- Keywords
- Early Breast cancer, Abemaciclib induced diarrea
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Henrik LindmanUniversity, hospital or other
- Study start
- 7 Jun 2023 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 30 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomization 1:1 to investigational product or placebo
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: SPC-flakes, Drug: SalovumSalovum 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 |
| Placebo Comparator | Placebo comparator | Drug: PlaceboPlacebo, identical to investigational product but without antisecretory factor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPC-flakesAktive drug | Drug | Experimental |
| SalovumActive drug | Drug | Experimental |
| PlaceboPlacebo drugs | Drug | Placebo Comparator |
Primary outcome
Occurrence of Abemaciclib induced diarrhea - STIDAT
Time frame: Three months
● Occurrence of any-grade (mild, moderate, severe) diarrhea according to the Systemic Treatment-Induced Diarrhea Assessment Tool (STIDAT; patient-reported outcome).
9 secondary outcomes
Occurrence of abemaciclib induced diarrhea - CTCAE
Time frame: Three months
QoL using FACT-B
Time frame: Three months
QoL using FACT-GP5
Time frame: Three months
QoL using FACIT-D
Time frame: Three months
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] besides diarrhea.
Time frame: Three months
Rate of patients that stop or interrupt treatment with investigational products
Time frame: Three months
Rate of patients that stop or interrupt treatment with abemaciclib
Time frame: Two years
Sick leave
Time frame: Two years
Breast cancer recurrence
Time frame: Two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henrik Lindman, MD, PhD principal investigator
Uppsala University Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SPC-flakes and Salovum in people with Early-stage Breast Cancer and Diarrhea, run by Henrik Lindman at 7 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Larsson (+46 18 611 39 45, maria.b.larsson@akademiska.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Abemaciclib induced diarrhea - STIDAT (time frame: Three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023.