breast cancer
Conditions
Interventions
Experimental group:Cedarbenamide + flurvestrum + sindilizumab
Control group:Cedarbenamide + flurvestrant
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Postmenopausal women aged 18-70 years; 2. Histological or cytological evidence of hormone receptor positive [estrogen receptor (ER) positive, progesterone receptor (PgR) negative or positive] breast cancer; 3. Early recurrence during neoadjuvant endocrine therapy or within 12 months after completion of neoadjuvant endocrine therapy or recurrence >12 months after completion of neoadjuvant endocrine therapy, progression after 1 line of endocrine therapy (anti-estrogen AI) or diagnosis of ABC, progression after 1 line of endocrine therapy (anti-estrogen /AI); 4. Chemotherapy is less than or equal to 1 line; 5. Patients with disease status of stage IV breast cancer, at least one measurable lesion or no measurable lesion and simple bone metastasis before enrollment could receive tumor cells or tissue samples for detection; 6. Time interval from the last treatment: (1) >=2 weeks if the last treatment was endocrine therapy; (2) >=4 weeks if the last treatment was chemotherapy; 7. ECOG score: 0 or 1; 8. Neutrophil absolute value >=1.5x 10^9 /L, platelet >=100x 10^9 /L, hemoglobin >=90g/L; 9 Expected survival time >=3 months; 10. Voluntary written informed consent.
Exclusion criteria
Exclusion criteria: 1. Past or present symptomatic central nervous system metastasis, or pia meningeal disease; 2. Human epidermal growth factor receptor 2 (Her-2) positive; 3. Previous treatment with fluvestran/citarbenamide; 4. A history of autoimmune disease; 5. Have been treated with immune checkpoint inhibitors; 6. Received systemic immune stimulants, systemic glucocorticoids or immunosuppressant therapy in the last 4 weeks; 7. Radiotherapy was performed within 4 weeks before inclusion; 8. No measurable lesions (except simple bone metastases), such as pleural or pericardial effusion, ascites, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective response rate;Disease control rate;Duration of response;Adverse events; | — |
Countries
China
Contacts
Public ContactShi Yanxia
Sun Yat-Sen University Cancer Center
Outcome results
None listed