Breast cancer
Conditions
Interventions
Case series:Chidamide plus fulvestrant
Sponsors
The Fourth Hospital of Hebei Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Female, aged over 18 years; 2. Histologically or cytologically confirmed ER and/or PR positive and HER-2 negative, postmenopausal and premenopausal breast cancer patients, but premenopausal patients need to be given ovarian function inhibition (OFS) therapy at the same time (menopausal criteria: Chinese premenopausal female breast cancer patients after adjuvant therapy menopausal judgment criteria and aromatase inhibitors clinical application. Chinese Journal of Cancer, 2012, 22 (3): 238-240.) 3. Patients with inoperable recurrent or metastatic breast cancer before enrollment, and at least one measurable lesion or no measurable lesion and simple bone metastasis; 4. Patients who received <=1 line of endocrine therapy at the stage of recurrence and metastasis regardless of the number of previous chemotherapy lines; 5. ECOG performance status score 0-2 points; 6. Voluntarily participate in this clinical trial.
Exclusion criteria
Exclusion criteria: 1. Patients who have received CDK4/6 inhibitors or mTOR inhibitors in the first line of advanced disease; 2. No measurable lesion, such as pleural or pericardial effusion, ascites, etc.; 3. Had undergone major surgical procedures or significant trauma within 4 weeks prior to enrollment, or anticipated that the patient would undergo major surgical treatment (non breast cancer related); 4. Those with known history of allergy to the components of the drugs of this protocol; 5.Have a history of immunodeficiency, including a positive HIV test, or have other acquired, congenital immunodeficiency diseases, or have a history of organ transplantation; 6. A positive pregnancy test at baseline in a pregnant, lactating female patient or a female of childbearing potential, Or reproductive age subjects who are unwilling to take effective contraception during study participation and at least 8 weeks after the last dose; 7. Serious harms to patient safety, or concomitant diseases affecting patient completion of the study (e.g.: severe hypertension, diabetes mellitus, thyroid disease, active infection, etc.) as judged by the investigator; 8. Previous clear history of neurological or psychiatric disorders, including epilepsy or dementia; 9. Not judged by the investigator to be suitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective response rate;Duration of response;Clinical benefit rate;Safety; | — |
Countries
China
Contacts
Public ContactLiu Yunjiang
The Fourth Hospital of Hebei Medical University
Outcome results
None listed