Famitinib in Combination With Camrelizumab and TPC in The First-line Treatment of Immunomodulatory Locally Advanced or Metastatic TNBC.

February 4, 2024 updated by: Zhimin Shao, Fudan University

An Open, Randomized Phase III Study of Famitinib With Camrelizumab Plus Treatment of Physician's Choice (TPC) Versus Camrelizumab Plus TPC in The First-line Treatment of Immunomodulatory Locally Advanced or Metastatic Triple-negative Breast Cancer

The study is being conducted to evaluate the Famitinib with Camrelizumab plus treatment of physician's choice (TPC) versus Camrelizumab plus TPC in Patients with Unresectable Locally Advanced or Metastatic Immunomodulatory Triple Negative Breast Cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

223

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Breast cancer institute of Fudan University Cancer Hospital
        • Sub-Investigator:
          • Ying Zhou
        • Contact:
        • Contact:
        • Principal Investigator:
          • Zhi-Ming Shao, MD
        • Sub-Investigator:
          • Lei Fan, MD
        • Sub-Investigator:
          • Wenjuan Zhang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ECOG Performance Status of 0-1
  • Expected lifetime of not less than three months
  • Metastatic or locally advanced, histologically documented TNBC (absence of HER2, ER, and PR expression)
  • Cancer stage: recurrent or metastatic breast cancer; Local recurrence be confirmed by the researchers could not be radical resection.
  • Adequate hematologic and end-organ function, laboratory test results.
  • Measurable disease according to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) • Patients had received no previous chemotherapy or targeted therapy for metastatic triple-negative breast cancer

Exclusion Criteria:

  • Previous received anti-VEGFR small molecule tyrosine kinase inhibitors (e.g. famitinib, sorafenib, Sunitinib, regorafenib, etc.) for treatment of the patients .
  • A history of bleeding, any serious bleeding events.
  • Important blood vessels around tumors has been infringed and high risk of bleeding.
  • Coagulant function abnormality
  • artery/venous thromboembolism event
  • History of autoimmune disease
  • Positive test for human immunodeficiency virus
  • Active hepatitis B or hepatitis C
  • Uncontrolled pleural effusion and ascites • Known central nervous system (CNS) disease.
  • Long-term unhealing wound or incomplete healing of fracture
  • urine protein ≥2+ and 24h urine protein quantitative > 1 g.
  • Pregnancy or lactation.
  • Thyroid dysfunction.
  • Peripheral neuropathy grade ≥2.
  • People with high blood pressure;
  • A history of unstable angina;
  • New diagnosis of angina pectoris.
  • Myocardial infarction incident .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Famitinib in Combination With Camrelizumab and TPC
Drug: Famitinib
TKI
Drug: Camrelizumab
PD1 inhibitor
Drug: nab-Palitaxel/Capecitabine/Eribulin Mesylate/Carboplatin
TPC
Active Comparator: B
Combination With Camrelizumab and TPC
Drug: Camrelizumab
PD1 inhibitor
Drug: nab-Palitaxel/Capecitabine/Eribulin Mesylate/Carboplatin
TPC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 1.5 years)
time to progressive disease (according to RECIST1.1)
Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 1.5 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: max 6 months
The proportion of participants whose best outcome is complete remission or partial remission (according to RECIST1.1)
max 6 months
DoR
Time Frame: max 6 months
Duration of Overall Response.The date of the first assessed PR/CR (according to RECIST 1.1) to the date of the first assessed tumor progression (according to RECIST 1.1) or death from any cause.
max 6 months
CBR
Time Frame: max 6 months
The percentage of subjects with CR+PR+SD and last more than 24 weeks in all of the participants.
max 6 months
OS
Time Frame: approximately 3 years
time to death due to any cause
approximately 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2023

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

February 27, 2023

First Submitted That Met QC Criteria

February 27, 2023

First Posted (Actual)

March 8, 2023

Study Record Updates

Last Update Posted (Estimated)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 4, 2024

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCTOP-T-M02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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