RecruitingPhase 3NCT05760378

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

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

Sponsor

Fudan University

Enrollment

223 participants

Start Date

Mar 17, 2023

Study Type

INTERVENTIONAL

Conditions

Triple-Negative Breast Cancer

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Inclusion Criteria6

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 Criteria18

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 .