advanced breast cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female, aged >= 18 years (including 18 years); 2. Histologically or cytologically confirmed breast cancer.Postmenopausal and premenopausal patients with hormone receptor-positive patients can be treated with ovarian function inhibition (OFS) at the same time, but premenopausal patients should be treated with ovarian function inhibition (menopausal criteria: judgment criteria of adjuvant therapy for postmenopausal women with breast cancer in China and consensus on clinical application of aromatase inhibitors. Chinese journal of cancer,2012,22(3):238-240.) 3. Patients with inoperable recurrent or metastatic breast cancer and at least one measurable lesion or no measurable lesion and simple bone metastasis before enrollment; 4. There is no limit to the number of lines of previous chemotherapy and total treatment; 5. ECOG physical condition score 0-2; 6. Volunteer to participate in this clinical trial and sign written informed consent.
Exclusion criteria
Exclusion criteria: 1. Received major surgical operations or significant trauma within 4 weeks prior to enrollment, or expected to receive major surgical treatment; 2. Those with a history of allergy to the drug components of the program; 3. A history of immunodeficiency, including HIV positive, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 4. Positive tests on baseline pregnancy tests for pregnant, lactating or fertile women; Subjects of childbearing age who were unwilling to use effective contraception during the study period and at least 8 weeks after the last administration; 5. Concomitant diseases (e.g., severe hypertension, diabetes, thyroid disease, active infection, etc.) that, as determined by the investigator, may seriously endanger the safety of the patient or affect the completion of the study; 6. A clear history of neurological or psychiatric disorders, including epilepsy or dementia; 7. The researcher judged that it was not suitable to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective remission rate;overall survival;Duration of remission;Clinical benefit rate; | — |
Countries
China
Contacts
West China Hospital, Sichuan University