Breast CancerPhase 4NCT05861635
The Study of Vidicizumab Combined With Tirelizumab in the Treatment of Breast Cancer With Low HER2 Expression
A Phase 4 study testing Disitamab Vedotin combined with Tislelizumab in people with Breast Cancer and Neoadjuvant Therapy, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
To evaluate the efficacy and safety of vidicizumab combined with tirelizumab in the treatment of early high-risk or locally advanced breast cancer with low HER2 expression Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Breast Cancer, Neoadjuvant Therapy
- What is being tested?
- Disitamab Vedotin combined with Tislelizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2023to 1 Feb 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 to 75 years old, male or female;
- Early or locally advanced breast cancer confirmed by pathology;
- Lymph node positive or lymph node negative, ER and PR negative, T ≥ 2 or lymph node negative, ER positive or PR positive, T ≥ 5;
- ECOG PS: 0-1; 5）Patients with low expression of HER-2: HER-2 IHC 1+or HER2 IHC 2+and ISH negative;
Who cannot join
- Stage IV breast cancer;
- Have received anti-tumor treatment or radiotherapy for any malignant tumor in the past five years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or squamous cell carcinoma;
- At the same time, other clinical trials have received anti-tumor therapy. If the researcher judges that the patient cannot benefit from the researcher, other anti-tumor therapy can be ended.
- The patient has undergone major surgery unrelated to breast cancer within 4 weeks before enrollment, or has not fully recovered from such surgery;
- Previously received ADC drugs, immunosuppressants, anti-HER2 and other treatments.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
WuhanHU
Wuhan, Hubei, 430000
Jing Yao, 02785726375, jeaneyph@163.com
About this study
Official title: Union Hospital Affiliated to Huazhong University of Science and Technology
To evaluate the efficacy and safety of vidicizumab combined with tirelizumab in the treatment of early high-risk or locally advanced breast cancer with low HER2 expression
Read the detailed description
Studies have shown that vidicizumab has good efficacy and safety in advanced HER-2 low expression breast cancer. Vidicizumab combined with immunotherapy may be a new adjuvant treatment option for HER-2 low expression breast cancer patients. Therefore, we plan to carry out a clinical study to evaluate the efficacy, safety and tolerance of vidicizumab combined with tirelizumab during neoadjuvant therapy, in order to provide new treatment options for patients with breast cancer with HER-2 low expression in neoadjuvant therapy, improve their prognosis and improve their quality of life
- Conditions
- Breast Cancer, Neoadjuvant Therapy
- Being tested
- Disitamab Vedotin combined with Tislelizumab
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disitamab Vedotin combined with TislelizumabDrug
Subjects who meet the requirements of the protocol will receive neoadjuvant treatment, and the specific administration arrangement is as follows:
Disitamab Vedotin, 2 mg/Kg, q2W, 8cycle Tislelizumab, 200mg, iv, q3W, 6cycle
| Study group | Role | What they receive |
|---|---|---|
| Disitamab Vedotin combined with Tislelizumab | Experimental | Subjects who meet the requirements of the protocol will receive neoadjuvant treatment, and the specific administration arrangement is as follows:
Disitamab Vedotin, 2 mg/Kg, q2W, 8cycle Tislelizumab, 200mg, iv, q3W, 6cycle Receives: Drug: Disitamab Vedotin combined with Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete remission (pCR) rate
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start1 Feb 2023
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jing Yao, Study director, Xiehe Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05861635
- Sponsor's protocol ID
- UHCT22575
- Status last verified
- Feb 2023
- First submitted
- 18 Feb 2023
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Union Hospital Affiliated to Huazhong University of Science and Technology
- ClinicalTrials.gov ID
- NCT05861635
- Acronym / sponsor ID
- UHCT22575
- Conditions
- Breast Cancer, Neoadjuvant Therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 17 May 2023 (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.
To evaluate the efficacy and safety of vidicizumab combined with tirelizumab in the treatment of early high-risk or locally advanced breast cancer with low HER2 expression
Detailed description
Studies have shown that vidicizumab has good efficacy and safety in advanced HER-2 low expression breast cancer. Vidicizumab combined with immunotherapy may be a new adjuvant treatment option for HER-2 low expression breast cancer patients. Therefore, we plan to carry out a clinical study to evaluate the efficacy, safety and tolerance of vidicizumab combined with tirelizumab during neoadjuvant therapy, in order to provide new treatment options for patients with breast cancer with HER-2 low expression in neoadjuvant therapy, improve their prognosis and improve their quality of life
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Disitamab Vedotin combined with Tislelizumab | Experimental | Drug: Disitamab Vedotin combined with TislelizumabSubjects who meet the requirements of the protocol will receive neoadjuvant treatment, and the specific administration arrangement is as follows: Disitamab Vedotin, 2 mg/Kg, q2W, 8cycle Tislelizumab, 200mg, iv, q3W, 6cycle |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: 18 to 75 years old, male or female;
- Early or locally advanced breast cancer confirmed by pathology;
- Lymph node positive or lymph node negative, ER and PR negative, T ≥ 2 or lymph node negative, ER positive or PR positive, T ≥ 5;
- ECOG PS: 0-1; 5）Patients with low expression of HER-2: HER-2 IHC 1+or HER2 IHC 2+and ISH negative;
Key exclusion criteria (5 listed)
- Stage IV breast cancer;
- Have received anti-tumor treatment or radiotherapy for any malignant tumor in the past five years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or squamous cell carcinoma;
- At the same time, other clinical trials have received anti-tumor therapy. If the researcher judges that the patient cannot benefit from the researcher, other anti-tumor therapy can be ended.
- The patient has undergone major surgery unrelated to breast cancer within 4 weeks before enrollment, or has not fully recovered from such surgery;
- Previously received ADC drugs, immunosuppressants, anti-HER2 and other treatments.
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 |
|---|---|---|
| Disitamab Vedotin combined with TislelizumabSubjects who meet the requirements of the protocol will receive neoadjuvant treatment, and the specific administration arrangement is as follows: Disitamab Vedotin, 2 mg/Kg, q2W, 8cycle Tislelizumab, 200mg, iv, q3W, 6cycle | Drug | Disitamab Vedotin combined with Tislelizumab |
Primary outcome
Pathological complete remission (pCR) rate
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Jing Yao study director
Xiehe Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Disitamab Vedotin combined with Tislelizumab in people with Breast Cancer and Neoadjuvant Therapy, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 17 May 2023. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing Yao, doctor (02785726375, jeaneyph@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete remission (pCR) rate (time frame: 16 weeks). 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 17 May 2023.