Sintilimab and Bevacizumab Biosimilar Combined With PLD in mTNBC

NCT ID: NCT05386524

Last Updated: 2023-02-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-15
• Study Completion Date: 2025-03-15

Brief Summary

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SBP group

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

Group Type: EXPERIMENTAL

sintilimab

Intervention Type: DRUG

sintilimab 200mg, ivgtt，d1

bevacizumab biosimilar

Intervention Type: DRUG

bevacizumab biosimilar 15mg/kg，ivgtt d1

pegylated liposomal doxorubicin

Intervention Type: DRUG

pegylated liposomal doxorubicin 30mg/m2 d1，q3w

Interventions

sintilimab

sintilimab 200mg, ivgtt，d1

Intervention Type: DRUG

bevacizumab biosimilar

bevacizumab biosimilar 15mg/kg，ivgtt d1

Intervention Type: DRUG

pegylated liposomal doxorubicin

pegylated liposomal doxorubicin 30mg/m2 d1，q3w

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Biyun Wang, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Biyun Wang, Prof

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Biyun Wang, Prof

Role: CONTACT

wangbiyun0107@hotmail.com

18017312387

Facility Contacts

Biyun Wang, Prof

Role: primary

wangbiyun0107@hotmail.com

18017312387

Other Identifiers

YOUNGBC-18

Identifier Type: -

Identifier Source: org_study_id