Breast CancerNCT06356519
Real-world Effectiveness and Safety Study of Sacituzumab Govitecan in Chinese Metastatic Breast Cancer
An observational study of Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
The aim of this trial is to explore the real-world effectiveness and poteintial predictors of Sacituzumab Govitecan in Chinese metastatic breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Sacituzumab Govitecan
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to 1 Apr 2025
- Phase
- Observational
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged over 18 years old with metastatic breast cancer included unresectable locally advanced breast cancer, de novo stage IV breast cancer, and recurrent metastatic breast cancer.
Who may be able to join
- Patients aged over 18 years old.
- Metastatic breast cancer included unresectable locally advanced breast cancer, de novo stage IV breast cancer, and recurrent metastatic breast cancer.
- Plan to receive or has received Sacituzumab Govitecan monotherapy
- Available medical history.
Who cannot join
- Incomplete medical history.
- Pregnancy or breast-breeding
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Biyun Wang, 18017312387, pro_wangbiyun@163.com
About this study
Official title: Effectiveness and Safety of Sacituzumab Govitecan in Chinese Metastatic Breast Cancer: A Multi-center Real-world Retrospective Study
The aim of this trial is to explore the real-world effectiveness and poteintial predictors of Sacituzumab Govitecan in Chinese metastatic breast cancer patients.
- Conditions
- Breast Cancer
- Being tested
- Sacituzumab Govitecan
- Keywords
- Sacituzumab Govitecan, breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacituzumab GovitecanDrug
Sacituzumab Govitecan,10 mg/kg ivgtt d1, d8, q3w
| Study group | Role | What they receive |
|---|---|---|
| Sacituzumab Govitecan | Sacituzumab Govitecan,10 mg/kg ivgtt d1, d8, q3w Receives: Drug: Sacituzumab Govitecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression free survival
Measured: 6 weeks
Secondary outcomes (3)
ORR
Overall Response Rate
Measured: 6 weeks
OS
Overall Survival
Measured: 6 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Safety
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start1 Mar 2024
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Apr 2025 (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 Fudan UniversityThe 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
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Biyun Wang, MD, Fudan University
- Investigators
- Biyun Wang, Professor, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06356519
- Sponsor's protocol ID
- YOUNGBC-29
- Status last verified
- Apr 2024
- First submitted
- 4 Apr 2024
- Last updated
- 10 Apr 2024
- 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 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Sacituzumab Govitecan in Chinese Metastatic Breast Cancer: A Multi-center Real-world Retrospective Study
- ClinicalTrials.gov ID
- NCT06356519
- Acronym / sponsor ID
- YOUNGBC-29
- Conditions
- Breast Cancer
- Keywords
- Sacituzumab Govitecan, breast cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 10 Apr 2024 (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.
The aim of this trial is to explore the real-world effectiveness and poteintial predictors of Sacituzumab Govitecan in Chinese metastatic breast cancer patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sacituzumab Govitecan | – | Drug: Sacituzumab GovitecanSacituzumab Govitecan,10 mg/kg ivgtt d1, d8, q3w |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged over 18 years old with metastatic breast cancer included unresectable locally advanced breast cancer, de novo stage IV breast cancer, and recurrent metastatic breast cancer.
Key inclusion criteria (4 listed)
- Patients aged over 18 years old.
- Metastatic breast cancer included unresectable locally advanced breast cancer, de novo stage IV breast cancer, and recurrent metastatic breast cancer.
- Plan to receive or has received Sacituzumab Govitecan monotherapy
- Available medical history.
Key exclusion criteria (2 listed)
- Incomplete medical history.
- Pregnancy or breast-breeding
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 |
|---|---|---|
| Sacituzumab GovitecanSacituzumab Govitecan,10 mg/kg ivgtt d1, d8, q3w | Drug | Sacituzumab Govitecan |
Primary outcome
PFS
Time frame: 6 weeks
Progression free survival
3 secondary outcomes
ORR
Time frame: 6 weeks
OS
Time frame: 6 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
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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.
Biyun Wang, Professor principal investigator
Fudan 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 Fudan University 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 2 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 10 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Biyun Wang, Professor (+8613701748410, pro_wangbiyun@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: 6 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 10 Apr 2024.