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
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 7
- 主要终点
- Occurrence of Abemaciclib induced diarrhea - STIDAT
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
double-blind, placebo controlled
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: SPC-flakes (Drug)
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
干预措施: Salovum (Drug)
Placebo Comparator
Placebo, identical to investigational product but without antisecretory factor.
干预措施: Placebo (Drug)
结局指标
主要结局
Occurrence of Abemaciclib induced diarrhea - STIDAT
时间窗: Three months
● Occurrence of any-grade (mild, moderate, severe) diarrhea according to the Systemic Treatment-Induced Diarrhea Assessment Tool (STIDAT; patient-reported outcome).
次要结局
- Occurrence of abemaciclib induced diarrhea - CTCAE(Three months)
- QoL using FACT-B(Three months)
- QoL using FACT-GP5(Three months)
- QoL using FACIT-D(Three months)
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] besides diarrhea.(Three months)
- Rate of patients that stop or interrupt treatment with investigational products(Three months)
- Rate of patients that stop or interrupt treatment with abemaciclib(Two years)
- Sick leave(Two years)
- Breast cancer recurrence(Two years)
研究者
Henrik Lindman
Coordinating Investigator
Uppsala University Hospital