NCT05760378 Famitinib in Combination With Camrelizumab and TPC in The First-line Treatment of Immunomodulatory Locally Advanced or Metastatic TNBC.
| NCT ID | NCT05760378 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Fudan University |
| Condition | Triple-Negative Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 223 participants |
| Start Date | 2023-03-17 |
| Primary Completion | 2025-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 223 participants in total. It began in 2023-03-17 with a primary completion date of 2025-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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 .
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05760378 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 70 Years, studying Triple-Negative Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05760378 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 223 participants.
Is NCT05760378 currently recruiting?
Yes, NCT05760378 is actively recruiting participants. Contact the research team at zhimingshao@yahoo.com for enrollment information.
Where is the NCT05760378 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT05760378 clinical trial?
NCT05760378 is sponsored by Fudan University. The trial plans to enroll 223 participants.
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