Innovation of the 1st line strategy optimized as abemaciclib with endocrine therapy based on the ESR1 mutation of ctDNA for HR-positive HER2-negative advanced metastatic breast cancer patients - Multi-institutional phase 2 trial (JBCRG-M08)
- Conditions
- Hormone receptor-positive, HER2-negative inoperable or recurrent breast cancer
- Registration Number
- JPRN-UMIN000051096
- Lead Sponsor
- Japan Breast Cancer Research Group (JBCRG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 150
Not provided
Exclusion criteria for primary enrollment 1. Patients with ILD/pneumonitits. 2. Patients with central nervous system metastases or carcinomatous meningitis. 3. Patients with active double cancer other than breast cancer. 4. Patients with breast cancer other than hormone receptor-positive, HER2-negative one of synchronous or the disease-free period (< 5 years before the day of primary enrollment). 5. Patients with active systemic bacterial infection. 6. Patients with known infection with HBV or HCV or HIV. 7. Patients with a complication or history of heart failure of NYHA class II to IV, ischemic heart disease, or arrhythmia requiring treatment. 8. Patients with syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin. 9. Patients with poorly controlled diabetes mellitus. 10. Patients with poorly controlled hypertension. 11. Patients with symptoms of dyspnea at rest. 12. Patients with pleural effusion, ascites, or cardiac effusion requiring drainage. 13. Women with childbearing intention, pregnant, or lactating. 14. Patients who do not wish to continue abemaciclib. 15. Patients with major surgery within 14 days prior to randomization. 16. Patients with an experimental treatment in a clinical trial within the last 30 days or 5 half-lives in any other type of medical research. 17. Patients participating or planning to do in other clinical researches. 18. Patients with hypersensitivity to letrozole, anastrozole, fulvestrant, or abemaciclib. 19. Patients with serious and/or uncontrolled preexisting medical condition(s) in the judgement of the investigator. 20. Patients judged by the investigator or subinvestigator to be inappropriate to participate in this research. Exclusion criteria for secondary enrollment 1. Patients with accompanying active infection requiring systemic treatment. 2. Patients unwilling to continue abemaciclib. 3. Patients judged by the investigator or subinvestigator to be inappropriate to continue this research.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 2-year PFS rate from the secondary enrollment (all arms)
- Secondary Outcome Measures
Name Time Method 1. 2-year PFS rate after the secondary enrollment (each arm): Key Secondary End Point 2. Rate of disappearance of ESR1 mutations in ctDNA with FUL+ABE: Key Secondary End Point 3. PFS from the secondary enrollment (all arms and each arm) 4. PFS from FUL+ABE initiation (arm FUL+ABE, arm Re-AI+ABE, and both arms) 5. PFS with Re-AI+ABE (arm Re-AI + ABE) 6. Overall survival (OS) (all arms and each arm) 7. Response rate and disease control rate (all arms and each arm) 8. Safety 9. Protocol treatment compliance rate