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

Primary Purpose

Triple-Negative Breast Cancer

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Famitinib
Camrelizumab
nab-Palitaxel/Capecitabine/Eribulin Mesylate/Carboplatin
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Triple-Negative Breast Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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 .

Sites / Locations

  • Breast cancer institute of Fudan University Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A

B

Arm Description

Famitinib in Combination With Camrelizumab and TPC

Combination With Camrelizumab and TPC

Outcomes

Primary Outcome Measures

PFS
time to progressive disease (according to RECIST1.1)

Secondary Outcome Measures

ORR
The proportion of participants whose best outcome is complete remission or partial remission (according to RECIST1.1)
DoR
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.
CBR
The percentage of subjects with CR+PR+SD and last more than 24 weeks in all of the participants.
OS
time to death due to any cause

Full Information

First Posted
February 27, 2023
Last Updated
June 5, 2023
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT05760378
Brief Title
Famitinib in Combination With Camrelizumab and TPC in The First-line Treatment of Immunomodulatory Locally Advanced or Metastatic TNBC.
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 17, 2023 (Actual)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
January 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Triple-Negative Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
223 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Famitinib in Combination With Camrelizumab and TPC
Arm Title
B
Arm Type
Active Comparator
Arm Description
Combination With Camrelizumab and TPC
Intervention Type
Drug
Intervention Name(s)
Famitinib
Intervention Description
TKI
Intervention Type
Drug
Intervention Name(s)
Camrelizumab
Intervention Description
PD1 inhibitor
Intervention Type
Drug
Intervention Name(s)
nab-Palitaxel/Capecitabine/Eribulin Mesylate/Carboplatin
Intervention Description
TPC
Primary Outcome Measure Information:
Title
PFS
Description
time to progressive disease (according to RECIST1.1)
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)
Secondary Outcome Measure Information:
Title
ORR
Description
The proportion of participants whose best outcome is complete remission or partial remission (according to RECIST1.1)
Time Frame
max 6 months
Title
DoR
Description
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.
Time Frame
max 6 months
Title
CBR
Description
The percentage of subjects with CR+PR+SD and last more than 24 weeks in all of the participants.
Time Frame
max 6 months
Title
OS
Description
time to death due to any cause
Time Frame
approximately 3 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 .
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhimin Shao
Phone
86-021-64175590
Ext
8888
Email
zhimingshao@yahoo.com
Facility Information:
Facility Name
Breast cancer institute of Fudan University Cancer Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhi-Ming Shao, MD
Phone
86-21-641755901105
Email
zhimingshao@yahoo.com
First Name & Middle Initial & Last Name & Degree
Lei Fan, MD
Phone
86-21-641755901105
Email
cmchen@medmail.com.cn
First Name & Middle Initial & Last Name & Degree
Zhi-Ming Shao, MD
First Name & Middle Initial & Last Name & Degree
Lei Fan, MD
First Name & Middle Initial & Last Name & Degree
Wenjuan Zhang, MD
First Name & Middle Initial & Last Name & Degree
Ying Zhou

12. IPD Sharing Statement

Learn more about this trial

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

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