A Trial Exploring the Opportune Administration of Nab-paclitaxel in the First Line Treatment, Camrelizumab Combined With Nab-paclitaxel and Famitinib, of TNBC.

Phase 2

Recruiting

• Conditions: Triple-Negative Breast Cancer
• Interventions: Drug: Camrelizumab plus Famitinib with/without nab-Palitaxel

• Registration Number: NCT05670925
• Lead Sponsor: Fudan University

Brief Summary

The study is being conducted to evaluate the Opportune Administration of Nab-paclitaxel in the First Line Treatment Strategy, Camrelizumab and Famitinib with/without Nab-paclitaxel, of Patients with Unresectable Locally Advanced or Metastatic Immunomodulatory Triple Negative Breast Cancer.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-02
• Study First Submitted QC: 2023-01-02
• Study First Posted: 2023-01-04
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-26
• Last Update Posted: 2023-02-28
• Study Start: 2023-03-01
• Primary Completion: 2023-09-01
• Study Completion: 2023-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 46

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

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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 ;

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Camrelizumab plus Famitinib with/without nab-palitaxel	Camrelizumab plus Famitinib with/without nab-Palitaxel	-

Primary Outcome Measures

Name	Time	Method
PFS	max 24 months	Progression Free Survival

Secondary Outcome Measures

Name	Time	Method
ORR	8 WEEKS	Objective Response Rate according to RECIST 1.1

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center Shanghai, China, 200032; 🇨🇳 Shanghai, Shanghai, China