A Single-arm, Prospective Phase Ⅱ Clinical Study of Utidelone Combined with Capecitabine in the Treatment of Active Brain Metastasis of Triple-negative Advanced Breast Cancer.

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥18 years old;

• 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;

• 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.

• 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;

• 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.

• 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);

• 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;

• The physical status score (ECOGPS) of the eastern cancer cooperative group is 0-2, and the life expectancy is more than 12 weeks;

• 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.

⁃ Neuropathy should be \< grade 2 within 4 weeks before enrollment (version 5.0 of ncictcae);

⁃ No major organ dysfunction and no heart disease;

⁃ 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.

Locations
Other Locations
China
Henan Breast Cancer Center, The Affiliated Cancer Hospital of Zhengzhou University
RECRUITING
Zhengzhou
Contact Information
Primary
Min Yan, Doctor
ym200678@126.com
+8615713857388
Time Frame
Start Date: 2024-06-19
Estimated Completion Date: 2026-08-01
Participants
Target number of participants: 48
Treatments
Experimental: One arm involving utidelone and capecitabine
Combination use of utidelone and capecitabine Utidelone 30 mg/m2 d1-5(single-day dose allowed ± 10% fluctuation) , once every three weeks; capecitabine: 1000 mg/m2, twice daily, orally after meal (one in the morning and one in the evening, with an interval of about 12 hours, equivalent to a daily dose of 2000 mg/m2) ; The drug was administered consecutively on days 1-14, with a 21-day cycle.
Related Therapeutic Areas
Sponsors
Leads: Henan Cancer Hospital

This content was sourced from clinicaltrials.gov