Sintilimab and Bevacizumab Biosimilar Combined With PLD in mTNBC

NCT05386524 | Unknown Phase 2

• 1 other identifier: YOUNGBC-18
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• PFS

  Progression free survival

  6 weeks

• OS

  Overall Survival

  6 weeks

• Adverse Events

  Number of participants with treatment-related adverse events as assessed by CTCAE v 5.0

  6 weeks

Study Arms (1)

SBP group

EXPERIMENTAL

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

Drug: sintilimab; Drug: bevacizumab biosimilar; Drug: pegylated liposomal doxorubicin

Interventions

sintilimab DRUG

sintilimab 200mg, ivgtt，d1

SBP group

bevacizumab biosimilar DRUG

bevacizumab biosimilar 15mg/kg，ivgtt d1

SBP group

pegylated liposomal doxorubicin DRUG

pegylated liposomal doxorubicin 30mg/m2 d1，q3w

SBP group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

sintilimab; liposomal doxorubicin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Biyun Wang, Prof

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Biyun Wang, Prof

CONTACT

18017312387; wangbiyun0107@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: May 23, 2022
• Study Start: June 15, 2022
• Primary Completion: March 15, 2025
• Study Completion: March 15, 2025
• Last Updated: February 16, 2023

Record last verified: 2023-02

Locations

CN (1)