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

ConditionMetastatic Breast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorHenan Cancer Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • Utidelone and capecitabine

    Drug

    Utidelone: intravenous capecitabine: oral

Treatment groups

48 Participants
are divided into 1 treatment group
Group A: One arm involving utidelone and capecitabineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

CNS-ORR（RANO Standard）

CNS-ORR（RANO Standard）

Time frame
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

1

CNS-ORR (RECIST1.1 standard)

CNS-ORR (RECIST1.1 standard)

Time frame
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.
2

CNS-PFS assessed by the investigator

CNS-PFS assessed by the investigator

Time frame
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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Henan Cancer Hospital

Lead sponsor

Source ClinicalTrials.gov
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