Phase II study of Trimebutine maleate and probiotics for Abemaciclib-induced diarrhea in patients with HR-positive and HER2-negative advanced breast cancer
- Conditions
- patients with HR-positive and HER2-negative advanced breast cancerHR-positive and HER2-negative advanced breast cancerD001943
- Registration Number
- JPRN-jRCTs031190154
- Lead Sponsor
- Masuda Hiroko
- Brief Summary
Although the incidence of diarrhea did not improve in both arms compared to historical data, bifidobacterial with or without TM shortened the duration of AID and prevented grade 3 or higher diarrhea, while the rate of constipation unchanged. As a result, the incidences of drug suspension/reduction were decreased.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 53
Histologically diagnosed hormone receptor positive, HER2 negative breast cancer
Stage 3B, 3C breast cancer that cannot be surgically removed, Stage IV breast
cancer suitable for endocrine therapy
ECOG performance status 0-2
No prior treatment with CDK 4/6 inhibitors
Type and number of previous treatments will not be considered in the selection criteria except CDK4/6 inhibitors
1, Patients who are administering a CYP3A inducer, inhibitor
2, Patients who receive continuous systemic administration of steroids or immunosuppressants
3, Cases of active bacterial infection, requiring intravenous injection of antibiotics at the start of the study, fungal infection, or detectable viral infection (known cases of HIV positive patients or known presence of active Hepatitis B and Hepatitis C infection in patients) Screening examination is not required for trial enrollment
4, Cases of pregnant and expecting mothers, breastfeeding mothers, potentially pregnant woman, or women who are not willing to use contraception
5, Patients with clinically challenging psychiatric disorders that would render trial enrollment difficult
6, Patients with a medical history of severe hypersensitivity
7, Exclusion criteria based on medical complications
a. Heart disease (history within the past year of fainting due to heart complications, along with cases of ventricular tachycardia, ventricular fibrillation, and cardiac arrest)
b. Constipation of more than Grade 2
c. Carcinomatous meningitis
d. Symptomatic central nervous system (CNS) metastasis
e. Uncontrollable cases of pericardial fluid, pleural effusion, and ascites accumulation
Furthermore, cases are excluded when deemed impossible to participate in the trial by the investigator or sub investigator of the study due to severe medical complications (such as interstitial lung disease, severe cases of dyspnea while resting or requiring oxygen therapy, history of large scale surgical resection in the stomach and small intestine, and cases of concomitant Crohn s Disease or ulcerative colitis and or chronic conditions in which diarrhea of more than Grade 2 exists as a baseline) or when determined as not appropriate by the physician in charge.
8, The patient has concurrent or history of interstitial lung disease including
lung fibrosis (ILD)/pneumonitis (any Grade).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Endpoint: Percentage of patients who experienced onset of Grade 2 or higher diarrhea during the trial duration of 28 days
- Secondary Outcome Measures
Name Time Method Secondary Endpoints: Safety over the course of the clinical trial period (up to 28 days), frequency and duration of all-grade diarrhea, frequency of emesis and constipation, comparative usage of loperamide in Arms A and B, QOL/PRO in the 28-day study duration