Breast cancer
Conditions
Interventions
Experimental group A:Chidamide+Fulvestrant+Sintinlimab
Experimental group B:Chidamide+Fulvestrant
Control group:Fulvestrant
Sponsors
Shandong Cancer Hospital and Institute
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The patient volunteered to participate in this study and signed the informed consent form; 2. Female, aged >= 18 years and <= 75 years (subject to the date of signing the informed Consent), Premenopausal and perimenopausal women should receive LHRH agonists; 3. Histological examination confirmed BC, that is, her-2 negative and HR positive; 4. There is at least one measurable lesion defined according to RECIST v1.1 or only bone metastatic lesions (including osteolytic or mixed osteolytic / osteogenic lesions). For a lesion that has received prior radiation therapy, it can be considered as a measurable lesion only if the lesion has a clear disease progression after radiation therapy; 5. Suitable for endocrine therapy with Fulvestrant alone; 6. In the past, patients with recurrent / metastatic diseases were not treated with antineoplastic therapy or first-line chemotherapy and / or first-line endocrine failure; (first-line chemotherapy failure is defined as disease progression or drug withdrawal due to toxicity intolerance after at least two cycles of first-line chemotherapy. First-line endocrine failure: progress during adjuvant endocrine therapy or within 12 months after the end of adjuvant endocrine therapy, or during advanced first-line endocrine therapy); 7. Prior local radiotherapy to the metastatic site is allowed, with no time limit for the end of radiotherapy, but patients are required to recover from the effects of radiotherapy before randomization; 8. Eastern Oncology Cooperative Group (ECOG) Physical condition score 0 or 1; 9. The expected survival time is 12 weeks; 10. Fertile women must have negative results from a serum pregnancy test within seven days of the first administration of the study drug and be willing to take adequate contraceptive measures during the trial and within six months after the last administration of the study drug.Postmenopausal women who have not yet reached postmenopausal status (amenorrhea lasting 12 months for no reason other than menopause) and have not had sterilization (ovaries and/or hysterectomy) are still considered fertile.
Exclusion criteria
Exclusion criteria: 1. There are life-threatening visceral metastatic diseases; 2. Patients with primary endocrine resistance(Adjuvant endocrine therapy for less than 2 years of disease recurrence,or advanced first-line endocrine therapy less than 6 months of disease progression); 3. Magnetic resonance imaging (MRI) evaluations during screening and prior imaging evaluations determined activity or untreated brain metastases; carcinomatous meningitis; 4. Patients are expected to receive any other systemic or local antitumor therapy during the course of the study; 5. Suffer from other malignant tumors less than 5 years before the first dose; 6. Women who are currently pregnant/lactating, or who plan to be pregnant during the study period and within 6 months after the last administration of the drug; 7. History of severe allergic reaction, rapid allergic reaction or other hypersensitivity to chimeric or humanized antibodies or fusion proteins; 8. Known to have hypersensitivity or anaphylaxis to any component of Fulvestrant group, LHRH agonist, or PD-1 antibody preparation; 9. Prior use of Fulvestrant, anti-PD-1 antibody, anti-PD-L1 antibody ,anti-PD-L2 antibody or anti-CTLA-4 antibody (or any other antibody acting on T cell synergistic stimulation or checkpoint pathway); 10. In the investigator's judgment, any other serious medical condition or clinical laboratory abnormality that may prevent the patient from safely participating in and completing the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Overall Survival;Disease contral rate;Time to objective remission, TTR;Adverse events; | — |
Countries
China
Contacts
Public ContactLihua Song
Shandong First Medical University
Outcome results
None listed