patients with HR-positive and HER2-negative advanced breast cancer HR-positive and HER2-negative advanced breast cancer
Conditions
Interventions
Both Arms A and B will receive hormone therapies (selected by physician in charge) as directed along with abemaciclib 150 mg bis in die (BID) over the course of 28 days. Both Arms A and B, simultaneou
D003967
diarrhea
Sponsors
Masuda Hiroko
Tsurutani Junji
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoint: Percentage of patients who experienced onset of Grade 2 or higher diarrhea during the trial duration of 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Contacts
Public ContactHiroko Masuda
Showa University Hospital
Outcome results
None listed