Breast CancerNCT05851677
Disitamab Vedotin (RC48-ADC) in Breast Cancer
An observational study of Breast Cancer, run by RenJi Hospital at 1 site in China.
Trial summary
To evaluate the efficacy and safety of Disitamab vedotin (RC48-ADC) in patients with breast cancer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Disitamab vedotin
- Type of treatment
- Injection or infusion
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to Aug 2027
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: breast cancer patients with prior or current use of Disitamab vedotin (RC48-ADC)
Who may be able to join
- Histologically confirmed breast cancer;
- Prior or current use of Disitamab vedotin (RC48-ADC);
Who cannot join
- Participating in clinical trials involving Disitamab vedotin (RC48-ADC) or not.
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
Renji Hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, 200127
Wenjin Yin, 86(21)68385569, yinwenjin@renji.com
About this study
Official title: Disitamab Vedotin (RC48-ADC) in Patients With Breast Cancer: a Real-world Study
To evaluate the efficacy and safety of Disitamab vedotin (RC48-ADC) in patients with breast cancer.
- Conditions
- Breast Cancer
- Being tested
- Disitamab vedotin
- 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 vedotinDrug
Also called RC48-ADC
recommended but not required regimen of 2.0mg/kg, iv, day1, every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| RC48-ADC | RC48-ADC for breast cancer Receives: Drug: Disitamab vedotin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival
The time from the date of starting Disitamab Vedotin to the date of disease progression as per RECIST version 1.1 or death from any cause, whichever occurs first.
Measured: From the date of starting Disitamab vedotin to the date of first documentation of progression or death (up to approximately 1 years)
Secondary outcomes (1)
Adverse events
Adverse events during Disitamab Vedotin regimen will be assessed according to the NCI CTCAE v5.0.
Measured: From the date of starting Disitamab vedotin to the end of the treatment (up to approximately 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 May 2023
- Study start1 Jun 2023
- Primary completionMar 2027 (estimated)
- Study completionAug 2027 (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 RenJi HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenjin Yin, RenJi Hospital
- Investigators
- Wenjin Yin, M.D., Principal investigator, Renji Hospital,School of Medicine, Shanghai Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05851677
- Sponsor's protocol ID
- LY2023-062-B
- Status last verified
- Sep 2025
- First submitted
- 30 Apr 2023
- Last updated
- 17 Sep 2025
- 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 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disitamab Vedotin (RC48-ADC) in Patients With Breast Cancer: a Real-world Study
- ClinicalTrials.gov ID
- NCT05851677
- Acronym / sponsor ID
- LY2023-062-B
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 10 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 Disitamab vedotin (RC48-ADC) in patients with breast cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RC48-ADC | – | Drug: Disitamab vedotinRC48-ADC for breast cancer |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- breast cancer patients with prior or current use of Disitamab vedotin (RC48-ADC)
Key inclusion criteria (2 listed)
- Histologically confirmed breast cancer;
- Prior or current use of Disitamab vedotin (RC48-ADC);
Key exclusion criteria (1 listed)
- Participating in clinical trials involving Disitamab vedotin (RC48-ADC) or not.
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 vedotinAlso: RC48-ADCrecommended but not required regimen of 2.0mg/kg, iv, day1, every 2 weeks | Drug | RC48-ADC |
Primary outcome
Progression-Free Survival
Time frame: From the date of starting Disitamab vedotin to the date of first documentation of progression or death (up to approximately 1 years)
The time from the date of starting Disitamab Vedotin to the date of disease progression as per RECIST version 1.1 or death from any cause, whichever occurs first.
1 secondary outcome
Adverse events
Time frame: From the date of starting Disitamab vedotin to the end of the treatment (up to approximately 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 17 Sep 2025.
- 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.
Wenjin Yin, M.D. principal investigator
Renji Hospital,School of Medicine, Shanghai Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by RenJi 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 2 inclusion and 1 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 17 Sep 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.
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 Wenjin Yin, M.D. (86(21)68385569, yinwenjin@renji.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (time frame: From the date of starting Disitamab vedotin to the date of first documentation of progression or death (up to approximately 1 years)). 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 Sep 2025.