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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Zhimin Shao
• Email: zhimingshao@yahoo.com
• Phone: 86-021-64175590

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Ivarmacitinib with Camrelizumab and Fruquintinib in advanced colorectal cancer after prior therapies

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.