Metastatic Breast Cancer
Conditions
Brief summary
This study aims to explore the efficacy and safety of the combination therapy of utidelone and capecitabine in the treatment of brain metastases from triple-negative advanced breast cancer, and to search for systemic treatment for brain metastases from triple-negative advanced breast cancer cases.
Interventions
DRUGUtidelone and capecitabine
Utidelone: intravenous capecitabine: oral
Sponsors
Henan Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years old; 2. Invasive breast cancer confirmed by histological or cytological examination, accompanied by metastatic disease; Patients with metastatic diseases not confirmed by pathology or cytology should obtain clear evidence of metastasis through physical examination or radiological research; 3. Based on the pathological report of recent biopsy or other pathological specimens (confirmed by the laboratory of the participating research center), the histology and/or cytology are confirmed as triple negative breast cancer. The specific requirements include: a) the definition of negative human epidermal growth factor receptor 2(HER2): the immunohistochemistry (IHC) is 0 or 1+; If IHC was 2+, it was confirmed negative by fluorescence in situ hybridization (FISH). B) Negative estrogen and progesterone receptors means that IHC examination shows ER \< 10% and or PR \< 10%, and the researcher evaluates that patients cannot benefit from endocrine therapy. 4. Newly diagnosed brain metastases or brain metastases that have progressed after local treatment: patients with brain metastases who met all the criteria of this scheme before starting from September 1, 2023 and did not meet all the
Exclusion criteria
can also be included; 5. Patients must have measurable central nervous system diseases, defined as at least one brain parenchymal lesion, which can be accurately measured in at least one dimension through local radiological examination; And there is no central nervous system symptom or symptom controllable, so radiotherapy is not needed urgently. 6. Patients who have previously received at least one taxane and/or one anthracycline antibiotic (as a treatment history of neoadjuvant therapy, adjuvant therapy or metastatic therapy or both); 7. Allow (new) adjuvant therapy to have recurrence and metastasis after stopping using Utterone and/or Capecitabine for more than one year, or stop taking drugs for non-progressive reasons in the rescue stage; 8. The physical status score (ECOGPS) of the eastern cancer cooperative group is 0-2, and the life expectancy is more than 12 weeks; 9. Normal organ and bone marrow function; Blood routine examination was basically normal within one week before joining the group (based on the normal laboratory of each research center): neutrophil count (ANC) ≥ 1.5× 109/L; Hemoglobin (HB) ≥ 90g/L; Platelet count (PLT) ≥ 75× 109/L; Liver and kidney function tests were basically normal within one week before enrollment (based on the normal values of laboratories in each research center): total bilirubin (TBIL)≤1.5× upper limit of normal value (ULN); Alanine aminotransferase (SGPT/ALT)≤2.5×ULN (patients with liver metastasis ≤ 5 XULN); Aspartate aminotransferase (SGOT/AST)≤2.5× upper limit of normal value (ULN); Creatinine clearance rate (Ccr)≥60ml/min. 10. Neuropathy should be \< grade 2 within 4 weeks before enrollment (version 5.0 of ncictcae); 11. No major organ dysfunction and no heart disease; 12. Women and male patients with reproductive potential must agree to use appropriate contraceptive measures before the start of the study and during the study participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CNS-ORR（RANO Standard） | From the date of enrollment to the date of first documented progression or death from any cause, whichever comes first，assessed up to 48 months. | CNS-ORR（RANO Standard） |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CNS-ORR (RECIST1.1 standard) | From the date of enrollment to the date of first documented progression or death from any cause, whichever comes first，assessed up to 48 months. | CNS-ORR (RECIST1.1 standard) |
| CNS-PFS assessed by the investigator | From the date of enrollment to the date of first documented progression or death from any cause, whichever comes first，assessed up to 48 months. | CNS-PFS assessed by the investigator |
Countries
China
Contacts
Primary ContactMin Yan, Doctor
Outcome results
None listed