A Single-arm, Prospective Phase Ⅱ Clinical Study of Utidelone Combined with Capecitabine in the Treatment of Active Brain Metastasis of TNBC

NCT06598046 | Recruiting Phase 2

• 1 other identifier: HNCH-MBC15-BM06
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• CNS-ORR（RANO Standard）

  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.

Secondary Outcomes (2)

• 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-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.

Study Arms (1)

One arm involving utidelone and capecitabine

EXPERIMENTAL

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.

Drug: Utidelone and capecitabine

Interventions

Utidelone and capecitabine DRUG

Utidelone: intravenous capecitabine: oral

One arm involving utidelone and capecitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Patients with extensive meningeal metastasis and brain metastasis who are ineffective in dehydration treatment with hormones or in urgent need of radiotherapy;
• 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;
• Received chemotherapy, major surgery, targeted therapy or immunotherapy within 2 weeks before joining the group (the interval between targeted therapy and immunotherapy is at least 2 weeks or at least 5 half-lives, whichever is shorter); Received endocrine therapy within 1 week before joining the group; He had received nitrosourea or mitomycin chemotherapy within 6 weeks before joining the group;
• Receive unlisted clinical trial drugs within 4 weeks before entering the group;
• Previous history of grade 3 or 4 allergic reactions related to Utterone or Capecitabine;
• inability to swallow, chronic diarrhea and intestinal obstruction, there are many factors that affect the taking and absorption of drugs;
• Known contraindications for gadolinium MRI contrast agents, such as pacemakers, shrapnel or ocular foreign bodies;

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Henan Breast Cancer Center, The Affiliated Cancer Hospital of Zhengzhou University

Zhengzhou, Henan, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Min Yan, Doctor

  Henan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Yan, Doctor

CONTACT

+8615713857388; ym200678@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: September 19, 2024
• Study Start: June 19, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)