Sintilimab and Bevacizumab Biosimilar Combined With PLD in mTNBC

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05386524
• Other study ID #: YOUNGBC-18
• Status: Recruiting
• Phase: Phase 2
• Start date: June 15, 2022
• Est. completion date: March 15, 2025

Study information

• Verified date: February 2023
• Source: Fudan University
• Contact: Biyun Wang, Prof
• Phone: 18017312387
• Email: wangbiyun0107[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 41
• Est. completion date: March 15, 2025
• Est. primary completion date: March 15, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• sintilimab
sintilimab 200mg, ivgtt,d1
• bevacizumab biosimilar
bevacizumab biosimilar 15mg/kg,ivgtt d1
• pegylated liposomal doxorubicin
pegylated liposomal doxorubicin 30mg/m2 d1,q3w

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS	Progression free survival	6 weeks
Primary	OS	Overall Survival	6 weeks
Primary	Adverse Events	Number of participants with treatment-related adverse events as assessed by CTCAE v 5.0	6 weeks