advanced breast cancer
Conditions
Interventions
1:Patients who have failed treatment with tamoxifen or aromatase inhibitors: Chidamide and Fulvestrant
2:Patients who have not been treated or failed treatment with tamoxifen: Chidamide and aromatase inhibitors
3:Triple-negative and Her-2 positive patients: Chidamide and PD-1 or anti-Her-2 treatment
Sponsors
The Fifth Medical Centre of Chinese PLA General Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Female aged >= 18 years; 2. Histological or cytologically confirmed breast cancer patients with ER or PR positive and HER-2 negative (hormone receptor positive), ER or PR negative and HER-2 negative (triple negative), and HER-2 positive. Hormone receptor positive patients could be both postmenopausal and premenopausal, but premenopausal patients need to be treated with ovarian function depression (OFS); 3. non-surgical relapsed or metastatic breast cancer; at least one measurable lesion or simple bone metastases with no measurable lesions; 4. Unlimited lines of previous chemotherapy and total treatment; 5. Eastern Cooperative Oncology Group Performance Status 0-2; 6. Have signed informed consent.
Exclusion criteria
Exclusion criteria: 1. No measurable lesions (except for simple bone metastases), such as pleural or pericardial exudate, ascites, etc .; 2. Patients have undergone major surgery or obvious trauma within 4 weeks before enrollment, or are expected to undergo major surgery; 3. Patients have a known history of allergies to the drug components of the study; 4. Patients have a history of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency disease, or a history of organ transplantation; 5. Positive baseline pregnancy tests in pregnant, lactating women, or fertile women; or subjects of reproductive age who are reluctant to take effective contraception during the study and at least 8 weeks after the last dose; 6. According to the investigator's judgment, there is a concomitant disease (such as severe hypertension, diabetes, thyroid disease, active infection, etc.) that seriously endangers the patient's safety or affects the completion of the study; 7. A clear history of neurological or mental disorders, including epilepsy or dementia; 8. The investigator determines that it is not appropriate to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;ORR;DOR;CBR; | — |
Countries
China
Contacts
Public ContactZefei Jiang
The Fifth Medical Centre of Chinese PLA General Hospital
Outcome results
None listed