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Recruiting Phase 3

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

NCT05760378 · tracked via the Priya Life Science China tracker
Phase
Phase 3
Started
2023-03-17
Last updated
2024-02-06

Condition(s) studied

Triple-Negative Breast Cancer

Investigational drug(s) / intervention(s)

Famitinib →Camrelizumab →nab-Palitaxel/Capecitabine/Eribulin Mesylate/Carboplatin

Famitinib: TKI

Camrelizumab: PD1 inhibitor

nab-Palitaxel/Capecitabine/Eribulin Mesylate/Carboplatin: TPC

Study 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
FEMALE
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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 .

Primary outcome measure(s)

  • PFS — 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)

Trial sites (1)

FacilityCityRegionStatus
Breast cancer institute of Fudan University Cancer Hospital Shanghai Shanghai Municipality Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05760378 on ClinicalTrials.gov ↗ ← All trials in China