Breast CancerPhase 2NCT05386524
Sintilimab and Bevacizumab Biosimilar Combined With PLD in mTNBC
A Phase 2 study testing sintilimab, bevacizumab biosimilar and pegylated liposomal doxorubicin in people with Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
To evaluate the efficacy and safety of sintilimab and bevacizumab biosimilar combined with pegylated liposomal doxorubicin in pretreated metastatic triple-negative breast cancer Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- sintilimab, bevacizumab biosimilar and pegylated liposomal doxorubicin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2022to 15 Mar 2025
- Phase
- Phase 2
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-70 years old.
- Metastatic breast cancer included unresectable locally advanced breast cancer, de novo stage IV breast cancer, and recurrent metastatic breast cancer.
- ER and PR negative, HER2 negative breast cancer.
- Received one or two lines of systemic treatment in metastatic setting
- Measurable disease based on RECIST 1.1.
- ECOG Performance Status 0-1
- Adequate hematological, renal and hepatic function according to all of the following laboratory values
Who cannot join
- Has received any prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent
- Has received any prior therapy with bevacizumab.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent)
- Has a known additional malignancy that is progressing or has required active treatment within the past 5 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (eg, cervical cancer in situ) that have undergone potentially curative therapy
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Has a known history of hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipient
Show all 12Show fewer
- Has an active autoimmune disease that has required systemic treatment
- Has a history of (non-infectious) pneumonitis that required treatment with steroids; or current pneumonitis.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
- Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
- Has been pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 180 days after the last dose of trial treatment.
- Failure to comply with the study procedures, restrictions and requirements of the study
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, Prof, 18017312387, wangbiyun0107@hotmail.com
About this study
Official title: Efficacy and Safety of Sintilimab and Bevacizumab Biosimilar Combined With Pegylated Liposomal Doxorubicin in Pretreated Metastatic Triple-negative Breast Cancer: a Single Arm Phase II Trial
To evaluate the efficacy and safety of sintilimab and bevacizumab biosimilar combined with pegylated liposomal doxorubicin in pretreated metastatic triple-negative breast cancer
- Conditions
- Breast Cancer
- Being tested
- sintilimab, bevacizumab biosimilar, pegylated liposomal doxorubicin
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sintilimabDrug
sintilimab 200mg, ivgtt，d1
bevacizumab biosimilarDrug
bevacizumab biosimilar 15mg/kg，ivgtt d1
pegylated liposomal doxorubicinDrug
pegylated liposomal doxorubicin 30mg/m2 d1，q3w
| Study group | Role | What they receive |
|---|---|---|
| SBP group | Experimental | sintilimab 200mg, ivgtt，d1， bevacizumab biosimilar 15mg/kg，ivgtt d1， pegylated liposomal doxorubicin 30mg/m2 d1，q3w Receives: Drug: sintilimab; Drug: bevacizumab biosimilar; Drug: pegylated liposomal doxorubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression free survival
Measured: 6 weeks
OS
Overall Survival
Measured: 6 weeks
Adverse Events
Number of participants with treatment-related adverse events as assessed by CTCAE v 5.0
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 posted23 May 2022
- Study start15 Jun 2022
- Primary completion15 Mar 2025 (estimated)
- Study completion15 Mar 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 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, Prof, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05386524
- Sponsor's protocol ID
- YOUNGBC-18
- Status last verified
- Feb 2023
- First submitted
- 18 May 2022
- Last updated
- 16 Feb 2023
- 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 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Sintilimab and Bevacizumab Biosimilar Combined With Pegylated Liposomal Doxorubicin in Pretreated Metastatic Triple-negative Breast Cancer: a Single Arm Phase II Trial
- ClinicalTrials.gov ID
- NCT05386524
- Acronym / sponsor ID
- YOUNGBC-18
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 15 Mar 2025 (estimated)
- Study completion
- 15 Mar 2025 (estimated)
- First posted
- 23 May 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.
To evaluate the efficacy and safety of sintilimab and bevacizumab biosimilar combined with pegylated liposomal doxorubicin in pretreated metastatic triple-negative breast cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SBP group | Experimental | Drug: sintilimab, Drug: bevacizumab biosimilar, Drug: pegylated liposomal doxorubicinsintilimab 200mg, ivgtt，d1， bevacizumab biosimilar 15mg/kg，ivgtt d1， pegylated liposomal doxorubicin 30mg/m2 d1，q3w |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients aged 18-70 years old.
- Metastatic breast cancer included unresectable locally advanced breast cancer, de novo stage IV breast cancer, and recurrent metastatic breast cancer.
- ER and PR negative, HER2 negative breast cancer.
- Received one or two lines of systemic treatment in metastatic setting
- Measurable disease based on RECIST 1.1.
Key exclusion criteria (12 listed)
- Has received any prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent
- Has received any prior therapy with bevacizumab.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent)
- Has a known additional malignancy that is progressing or has required active treatment within the past 5 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (eg, cervical cancer in situ) that have undergone potentially curative therapy
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
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 |
|---|---|---|
| sintilimabsintilimab 200mg, ivgtt，d1 | Drug | SBP group |
| bevacizumab biosimilarbevacizumab biosimilar 15mg/kg，ivgtt d1 | Drug | SBP group |
| pegylated liposomal doxorubicinpegylated liposomal doxorubicin 30mg/m2 d1，q3w | Drug | SBP group |
Primary outcome
PFS
Time frame: 6 weeks
Progression free survival
OS
Time frame: 6 weeks
Overall Survival
Adverse Events
Time frame: 6 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v 5.0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
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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, Prof 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?
A Phase 2 study testing sintilimab, bevacizumab biosimilar and pegylated liposomal doxorubicin in people with 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 7 inclusion and 12 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 16 Feb 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Biyun Wang, Prof (18017312387, wangbiyun0107@hotmail.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). The study lists 3 primary outcomes in all. 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 16 Feb 2023.