Sintilimab and Bevacizumab Biosimilar Combined With PLD in mTNBC

Fudan University (Other)
Overall Status
Recruiting ID

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Drug: sintilimab
  • Drug: bevacizumab biosimilar
  • Drug: pegylated liposomal doxorubicin
Phase 2

Study Design

Study Type:
Anticipated Enrollment :
41 participants
Intervention Model:
Single Group Assignment
None (Open Label)
Primary Purpose:
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
Anticipated Study Start Date :
Jun 15, 2022
Anticipated Primary Completion Date :
Mar 15, 2025
Anticipated Study Completion Date :
Mar 15, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. PFS [6 weeks]

    Progression free survival

  2. OS [6 weeks]

    Overall Survival

  3. Adverse Events [6 weeks]

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

Eligibility Criteria


Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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

Contacts and Locations


Site City State Country Postal Code
1 Fudan University Shanghai Cancer Center Shanghai Shanghai China 200032

Sponsors and Collaborators

  • Fudan University


  • Principal Investigator: Biyun Wang, Prof, Fudan University

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Biyun Wang, MD, Professor, Fudan University Identifier:
Other Study ID Numbers:
  • YOUNGBC-18
First Posted:
May 23, 2022
Last Update Posted:
May 26, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 26, 2022