UTD1 Combined With Capecitabine in Metastatic HER2-negative Breast Cancer Patients With Brain Metastases

NCT05535413 | Recruiting Phase 1

• 1 other identifier: HNCH-2022KY59
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a single-arm, multicenter, open-labeled clinical study of UTD1 combined with Capecitabine in metastatic HER2-negative breast cancaner patients with brain metastases. This study aims to evaluate the efficacy and safety of UDT1 combined with capecitabine in metastatic HER2-negative breast cancer patients with brain metastases.

Conditions

Metastatic HER2 Negative Breast Carcinoma; Brain Metastases; Capecitabine; UDT1

Outcome Measures

Primary Outcomes (1)

• CNS-Objective Response Rate (ORR)

  The proportion of patients with complete remission (CR) and partial remission (PR) as the best efficacy evaluation in the total number of evaluable patients observed during the process from enrollment to the progression of all CNS target lesions assessed according to the RANOBM criteria.

  From the enrollment to the progression of all CNS target lesions assessed according to RANOBM standard up to 1 year.

Secondary Outcomes (5)

• CNS clinical benefit rate (CNS-CBR)

  From the enrollment to the progression of all CNS target lesions assessed according to RANOBM standard up to 1 year.

• CNS progression free survival (CNS-PFS)

  From enrollment to the first imaging confirmed disease progression (PD) of all central nervous system target lesions (RANOBM criteria) or death due to any cause without progression recorded up to 1 year.

• CNS objective response rate (CNS-ORR)

  From the enrollment to the progression of all CNS target lesions assessed according to RECIST 1.1 standard up to 1 year.

• Objective response rate (ORR)

  From the enrollment to the progression of all CNS target lesions assessed according to RECIST standard up to 1 year.

• Progressive survival (PFS)

  From the enrollment to the progression of all CNS target lesions assessed according to RECIST standard up to 1 year.

Study Arms (1)

UDT1 combined with capecitabine

EXPERIMENTAL

Drug: UTD1 combined with capecitabine

Interventions

UTD1 combined with capecitabine DRUG

UTD1: 30mg/m2/day, once a day, continuously from day 1 to day 5, 21 days as a treatment cycle. Capecitabine: 2000mg / m2 / day, continuously from day 1 to day 14, orally twice a day, 21 days as a treatment cycle.

UDT1 combined with capecitabine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 to 70 years
• With histologically confirmed HER2 negative recurrent and metastatic breast cancer
• have at least one measurable lesion in the central nervous system (the longest diameter ≥ 10mm)
• ECOG score (PS) of 0-2
• According to screening brain MRI, patients with CNS must meet the following conditions:
• untreated brain metastases of breast cancer;
• do not need immediate local treatment;
• brain metastases of breast cancer which was treated in the past:
• There are no clinical manifestations that have progressed after the previous local treatment of the central nervous system and require immediate local treatment.
• All records related to the treatment of the central nervous system must be provided.
• All toxicities related to the previous anti-tumor treatment of patients who have not received chemotherapy, radiotherapy, surgical treatment, targeted therapy and immunotherapy within 4 weeks before enrollment must be restored to ≤ level 1 (CTCAE v50). However, patients with hair loss of any grade are allowed to be recruited.
• Blood routine examination was basically normal within 1 week before enrollment.
• White blood cell count (WBC) ≥ 30 × 109 /L
• Neutrophil counts (ANC) ≥ 15 × 109/L
• Platelet count (PLT) ≥ 100 × 109 /L

You may not qualify if:

• Primary or metastatic lesions were HER2 positive (HER2 IHC or FISH positive)
• Other malignant carcinomas (including primary brain or leptomeningeal related tumors) in the past 5 years, except for the cured basal cell carcinoma of the skin and carcinoma in situ of the cervix.
• Anti tumor treatment, including chemotherapeutic radical radiotherapy, hormone therapy, biological therapy Immunotherapy or anti-tumor traditional Chinese medicine.
• Patients who have received surgical operation on major organs (excluding puncture biopsy) or have suffered significant trauma within 4 weeks before the first use of the study drug, or who need to undergo elective surgery during the trial.
• Patients with symptomatic peripheral neuropathy with grade evaluation ≥ 2 (CTCAE 5.0), who have previously used anti-microtubule drugs and have serious adverse reactions related to the nervous system of grade 3 or above.
• Use capecitabine within 6 months before enrollment; No response to capecitabine in the past (including progression during capecitabine treatment, or duration of clinical response after treatment \< 3 months) or unable to tolerate to capecitabine.
• For any brain lesions requiring immediate local treatment, such as increased lesion size or treatment-related edema at intracranial (but not limited to) anatomical sites may pose risks to patients (e.g., brainstem lesions)
• Known or suspected leptomeningeal disease (LMD)
• Other non malignant systemic diseases (cardiovascular, renal, liver, etc.) that are excluded from any treatment regimen or interfere with follow-up in pregnant or lactating women.
• Known or suspected allergy to any study drug or accessories.
• Brain MRI can not be performed for any other reason.
• The investigator considers it inappropriate to participate in.
• Other situations where corticosteroids are prohibited.

Sponsors & Collaborators

• Hunan Cancer Hospital: lead

Study Sites (1)

Quchang Ouyang

Changsha, 410000, China

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System 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

Central Study Contacts

Quchang Ouyang

CONTACT

+8673189762161; oyqc1969@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: September 10, 2022
• Study Start: January 1, 2023
• Primary Completion: October 31, 2024
• Study Completion: July 1, 2025
• Last Updated: April 25, 2025

Record last verified: 2025-04

Locations

CN (1)