What is UTD1 studying for metastatic HER2-negative breast cancer with brain metastases?

UTD1 is being studied in combination with capecitabine to evaluate its effect on metastatic HER2-negative breast cancer patients with brain metastases. The study aims to understand how well this combination works and its safety profile in this patient group. It is sponsored by Hunan Cancer Hospital.

Who may be eligible for this metastatic HER2-negative breast cancer clinical trial?

Adults aged 18 to 70 years with histologically confirmed HER2-negative recurrent or metastatic breast cancer and at least one measurable brain lesion may be eligible. Only female patients can participate, and good performance status (ECOG 0-2) is required. Please review eligibility criteria for more details.

Is there any cost to participate in this metastatic HER2-negative breast cancer clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel-related costs.

Actively Recruiting

Phase 1

Phase 2

Age: 18Years - 70Years

FEMALE

ID05535413

Study of UTD1 and Capecitabine Treatment in Women Aged 18 to 70 With Metastatic HER2-negative Breast Cancer and Brain Metastases

Led by Hunan Cancer Hospital · Updated on 2025-04-25

Participants Needed

Research Sites

34 weeks

Total Duration

AI-Summary

What this Trial Is About

This research evaluates the combination of UTD1 and capecitabine in patients with metastatic HER2-negative breast cancer who also have brain metastases. It is a single-arm, multicenter, open-label clinical study aiming to assess how effective and safe this combined treatment is for this specific patient group. Participants receive UTD1 at a dose of 30 mgm2 daily for 5 days in each 21-day treatment cycle, along with capecitabine taken orally at 2000 mgm2 daily for 14 days per 21-day cycle. The treatment continues under close observation as part of this phase 1 and phase 2 study. During the study, patients undergo regular brain MRI scans and other laboratory tests to monitor treatment response and safety. The main measure is the central nervous system objective response rate assessed up to one year. Additional outcomes include clinical benefit rate, progression-free survival, and response rates, with careful tracking of side effects and overall health throughout the participation period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 70Years

FEMALE

Eligibility Criteria

You may qualify if you...

Patients aged 18 to 70 years
Histologically confirmed HER2 negative recurrent and metastatic breast cancer
At least one measurable lesion in the central nervous system with longest diameter 210 mm
ECOG performance status of 0 to 2
Untreated or previously treated brain metastases meeting specific stability and treatment toxicity criteria
Blood routine examination within normal limits before enrollment
White blood cell count 230 �d7 10^9 /L, neutrophil count 215 �d7 10^9/L, platelet count 2100 �d7 10^9 /L, hemoglobin 290 g/dl
Normal liver and kidney function tests within one week before enrollment
Total bilirubin 215 �d7 upper limit of normal
Alanine aminotransferase (ALT) 25 �d7 ULN (up to 5 �d7 ULN for patients with liver metastasis)
Aspartate transaminase (AST) 25 �d7 ULN (up to 5 �d7 ULN for patients with liver metastasis)
Creatinine clearance rate 260 ml/min
Negative pregnancy test and agreement to use effective contraception during study and 90 days after
Life expectancy greater than 12 weeks
Ability to participate and follow treatment and follow-up

You will not qualify if you...

HER2 positive primary or metastatic lesions
Other malignant cancers in past 5 years except cured basal cell carcinoma or carcinoma in situ of cervix
Recent anti-tumor treatments within 4 weeks before study drug use
Surgery on major organs or major trauma within 4 weeks before first study drug use
Symptomatic peripheral neuropathy grade 2 or serious nervous system adverse reactions grade 3 or above
Use of capecitabine within 6 months prior or no response/tolerance to capecitabine
Brain lesions needing immediate local treatment or with increased size or edema posing risk
Known or suspected leptomeningeal disease
Non-malignant systemic diseases interfering with treatment or follow-up
Allergy to study drugs or accessories
Inability to undergo brain MRI
Investigator judgment of unsuitability
Conditions prohibiting corticosteroid use

Research Team

Quchang Ouyang

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Study of UTD1 and Capecitabine Treatment in Women Aged 18 to 70 With Metastatic HER2-negative Breast Cancer and Brain Metastases

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria