Sintilimab and Bevacizumab Biosimilar Combined With PLD in mTNBC

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

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: sintilimab; Drug: bevacizumab biosimilar; Drug: pegylated liposomal doxorubicin

• Study Type: Interventional
• Enrollment (Anticipated): 41
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Fudan University Shanghai Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SBP group; sintilimab 200mg, ivgtt，d1， bevacizumab biosimilar 15mg/kg，ivgtt d1， pegylated liposomal doxorubicin 30mg/m2 d1，q3w	Drug: sintilimab; sintilimab 200mg, ivgtt，d1; Drug: bevacizumab biosimilar; bevacizumab biosimilar 15mg/kg，ivgtt d1; Drug: pegylated liposomal doxorubicin; pegylated liposomal doxorubicin 30mg/m2 d1，q3w

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2022
• Primary Completion (Anticipated): March 15, 2025
• Study Completion (Anticipated): March 15, 2025

Study Registration Dates

• First Submitted: May 18, 2022
• First Submitted That Met QC Criteria: May 18, 2022
• First Posted (Actual): May 23, 2022

Study Record Updates

• Last Update Posted (Actual): February 16, 2023
• Last Update Submitted That Met QC Criteria: February 14, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Antibiotics, Antineoplastic; Bevacizumab; Doxorubicin; Liposomal doxorubicin
• Other Study ID Numbers: YOUNGBC-18

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No