OncoMatch/Clinical Trials/NCT06764940
A Pivotal Phase II Clinical Trial of Utidelone Injection Plus Capecitabine in HER2-negative Breast Cancer Patients With Brain Metastases
Is NCT06764940 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Utidelone and Utidelone in combination with capecitabine for her2-negative breast cancer patients with brain metastases.
Treatment: Utidelone · Utidelone in combination with capecitabine · Utidelone in combination with capecitabine · Utidelone in combination with capecitabine — This study is a multicenter, two-stage clinical trial to evaluate the efficacy and safety of utidelone in combination with capecitabine in patients with HER2-negative breast cancer with brain metastases. Patients will be enrolled to receive treatment of utidelone alone or in combination with capecitabine. The objectives both in stage I and stage II are to evaluate the intracranial and systemic efficacy and safety of utdelone plus capecitabine for the treatment of HER2-negative breast cancer patients with brain metastases.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) HER2-negative (IHC 0 or 1+, or IHC2+ with negative ISH) (IHC 0 or 1+, or IHC2+ with negative ISH)
HER2-negative defined as immunohistochemical (IHC) score of 0 or 1+, or IHC2+ with negative HER2 expression on in situ hybridization (ISH)
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: capecitabine (capecitabine)
Exception: This applies only to the combination cohort and does not apply to the monotherapy cohort. For patients with previous capecitabine treatment, the prior use of capecitabine meets any of the following criteria: A) The best response during prior capecitabine combination therapy or monotherapy is Progressive Disease (PD); B) Have received capecitabine treatment within 6 months prior to the first study treatment.
For patients with previous capecitabine treatment, the prior use of capecitabine meets any of the following criteria: A) The best response during prior capecitabine combination therapy or monotherapy is Progressive Disease (PD); B) Have received capecitabine treatment within 6 months prior to the first study treatment.
Cannot have received: any anti-tumor therapies
Patients who have received anti-tumor therapies less than 2 weeks before the first dose of investigational product, including endocrine therapy, chemotherapy, radiotherapy, biotherapy, targeted therapy, immunotherapy or antibody-drug conjugate therapy.
Lab requirements
Blood counts
adequate baseline hematologic parameters
Kidney function
adequate renal function
Liver function
adequate hepatic function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope--Duarte · Duarte, California
- Cancer & Blood Research Center, LLC · Los Alamitos, California
- Univ. of California Los Angeles · Los Angeles, California
- FOMAT Medical Research (Network) · Oxnard, California
- Scripps Health · San Diego, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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