Combining Famitinib and Camrelizumab for Treating Advanced Triple-Negative Breast Cancer

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

This study is testing if combining Famitinib with Camrelizumab can help people with advanced triple-negative breast cancer do better than just using Camrelizumab with another treatment.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 223 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: Fudan University (Academic / other)
• Drugs / interventions: famitinib, Sunitinib, chemotherapy, Camrelizumab
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT05760378 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of Famitinib in combination with Camrelizumab and a treatment of physician's choice (TPC) compared to Camrelizumab plus TPC alone in patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC). The study aims to determine if this combination can improve treatment outcomes for patients who have not previously received chemotherapy or targeted therapy for their metastatic TNBC. Participants will be monitored for measurable disease progression using established criteria.

Who should consider this trial

Good fit: Ideal candidates are patients with unresectable locally advanced or metastatic TNBC who have not received prior chemotherapy or targeted therapy.

Not a fit: Patients with a history of bleeding events or those who have previously received anti-VEGFR small molecule tyrosine kinase inhibitors may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment approach could provide a new effective option for patients with advanced triple-negative breast cancer.

How similar studies have performed: While this specific combination is novel, similar approaches in targeting TNBC have shown promise in other studies.

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 .

Where this trial is running

Shanghai, Shanghai Municipality

• Breast cancer institute of Fudan University Cancer Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Zhimin Shao

Conditions Triple-Negative Breast Cancer