Metastatic HER2 Negative Breast CarcinomaPhase 1/2NCT05535413
UTD1 Combined With Capecitabine in Metastatic HER2-negative Breast Cancer Patients With Brain Metastases
A Phase 1/2 study testing UTD1 combined with capecitabine in people with Metastatic HER2 Negative Breast Carcinoma and Brain Metastases, run by Hunan Cancer Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Metastatic HER2 Negative Breast Carcinoma, Brain Metastases, Capecitabine
- What is being tested?
- UTD1 combined with capecitabine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to Jul 2025
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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
- Hemoglobin ≥ 90g/dl. Patients can receive blood transfusion or erythropoietin treatment to meet this standard.
- Within 1 week before enrollment, the liver and kidney function tests were basically normal (based on the normal value of the laboratory of each research center).
- Total bilirubin ≤ 15 × Upper limit of normal value (ULN)
- Alanine aminotransferase (SGPT / ALT) ≤ 25 x ULN (patients with liver metastasis ≤ 5 × ULN)
- Glutamic oxaloacetic transaminase (SGOT/AST) ≤ 25 × ULN (patients with liver metastasis ≤ 5 × ULN)
- Creatinine clearance rate (Ccr) ≥ 60ml/min patients
- With fertility must agree to use effective contraceptive methods during the study period and within 90 days of the last study medication. Before enrollment, the blood or urine pregnancy test must be negative and the
- Life expectancy > 12 weeks.
- The patient must be able to participate in and follow the treatment and follow-up.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Quchang Ouyang
Changsha, 410000
Quchang Ouyang, +8673189762161, oyqc1969@126.com
About this study
Official title: A Single-arm, Multicenter, Open-labeled Clinical Study of UTD1 Combined With Capecitabine in Metastatic HER2-negative Breast Cancer Patients With Brain Metastases
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.
- Being tested
- UTD1 combined with capecitabine
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UTD1 combined with capecitabineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| UDT1 combined with capecitabine | Experimental | Not described Receives: Drug: UTD1 combined with capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
The percentage of patients who achieved complete response (CR), partial response (PR) or disease stability (SD) as the best efficacy evaluation in the total number of evaluable patients observed from enrollment to all CNS target lesions assessed according to the RANOBM criteria.
Measured: 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)
The time 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.
Measured: 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)
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 RECIST 1.1 criteria.
Measured: 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)
According to RECIST 1.1 criteria, the number of patients with the best efficacy evaluation of CR or PR during the process from enrollment to disease progression accounts for the proportion of the total number of evaluable patients.
Measured: From the enrollment to the progression of all CNS target lesions assessed according to RECIST standard up to 1 year.
Progressive survival (PFS)
The time from enrollment and disease progression (PD) confirmed by imaging from enrollment to the first time (RECIST 1.1 criteria) or death without progress is recorded but due to any cause.
Measured: From the enrollment to the progression of all CNS target lesions assessed according to RECIST standard up to 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start1 Jan 2023
- Primary completion31 Oct 2024
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic HER2 Negative Breast CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hunan Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05535413
- Sponsor's protocol ID
- HNCH-2022KY59
- Status last verified
- Apr 2025
- First submitted
- 18 Aug 2022
- Last updated
- 25 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Multicenter, Open-labeled Clinical Study of UTD1 Combined With Capecitabine in Metastatic HER2-negative Breast Cancer Patients With Brain Metastases
- ClinicalTrials.gov ID
- NCT05535413
- Acronym / sponsor ID
- HNCH-2022KY59
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hunan Cancer HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- Jul 2025 (estimated)
- First posted
- 10 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UDT1 combined with capecitabine | Experimental | Drug: UTD1 combined with capecitabine |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- 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:
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UTD1 combined with capecitabineUTD1: 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. | Drug | UDT1 combined with capecitabine |
Primary outcome
CNS-Objective Response Rate (ORR)
Time frame: From the enrollment to the progression of all CNS target lesions assessed according to RANOBM standard up to 1 year.
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.
5 secondary outcomes
CNS clinical benefit rate (CNS-CBR)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: From the enrollment to the progression of all CNS target lesions assessed according to RECIST standard up to 1 year.
Progressive survival (PFS)
Time frame: From the enrollment to the progression of all CNS target lesions assessed according to RECIST standard up to 1 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing UTD1 combined with capecitabine in people with Metastatic HER2 Negative Breast Carcinoma and Brain Metastases, run by Hunan Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Quchang Ouyang (+8673189762161, oyqc1969@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CNS-Objective Response Rate (ORR) (time frame: From the enrollment to the progression of all CNS target lesions assessed according to RANOBM standard up to 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.