A Study of Chidamide Plus Endocrine in Maintenance Treatment of HR+/HER2- Breast Cancer Af
To explore the efficacy and safety of Chidamide combined with endocrine for maintenance therapy after first-line chemotherapy for HR+/HER2- breast cancer
| Condition(s) | HR Positive HER2 Negative Advanced Breast Cancer |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | To explore the efficacy and safety of Chidamide combined with endocrine for maintenance therapy after first-line chemotherapy for HR+/HER2- breast cancer |
| Who can participate | Inclusion Criteria: 1. Postmenopausal/premenopausal women aged ≥18 years and ≤70 years; 2. HR + / HER2 breast cancer confirmed by histology (note: her2-negative is defined as: (1) IHC1 + / IHC0; ②IHC2+ : FISH-); 3. Confirmed by the histology of locally advanced breast cancer (local treatment) to radical or recurrent metastatic breast cancer; 4. In the late stage of untreated or experienced a CDK4/6 with endocrine therapy of patients; 5. Researchers think that for selecting patients with chemotherapy (step 2022 guidelines recommend for internal transfer, always endocrine therapy resistance or preferred to rescue patients with endocrine therapy best choice of chemotherapy); 6. One line finish cycle disease after chemotherapy (4 to 8 cycles) to alleviate or stable, quasi follow-up maintenance |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Lead sponsor | Tianjin Medical University Cancer Institute and Hospital |
| Locations | Tianjin, China |
| Start date | 2023-05-16 |
| NCT ID | NCT05890287 |
| Official listing | https://clinicaltrials.gov/study/NCT05890287 |