A Trial of Camrelizumab in Combination With Nab-paclitaxel and Famitinib as a First Line Treatment in Patients With Unresectable Locally Advanced or Metastatic Immunomodulatory Triple Negative Breast Cancer(FUTURE-C-PLUS)

Phase 2

• Conditions: Triple-Negative Breast Cancer
• Interventions: Drug: camrelizumab in combination with nab-paclitaxel and famitinib

• Registration Number: NCT04129996
• Lead Sponsor: Fudan University

Brief Summary

The study is being conducted to evaluate the efficacy, safety of camrelizumab in combination with nab-paclitaxel and famitinib in Patients with unresectable locally advanced or metastatic immunomodulatory triple negative breast Cancer..

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-10-01
• Study First Submitted: 2019-10-11
• Study First Submitted QC: 2019-10-15
• Study First Posted: 2019-10-17
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-07
• Last Update Posted: 2022-01-11
• Primary Completion: 2022-09-01
• Study Completion: 2022-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• 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 ;
• Arrhythmia for long-term use of anti-arrhythmic drugs and New York heart association class II or higher cardiac insufficiency

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
camrelizumab in combination with nab-paclitaxel and famitinib	camrelizumab in combination with nab-paclitaxel and famitinib	-

Primary Outcome Measures

Name	Time	Method
ORR	Baseline up to 53 months (assessed at Screening, every 8 weeks for the first 12 months, thereafter every 12 weeks until disease progression or death, whichever occurs first	Percentage of Participants With an Objective Response of Complete Response (CR) or Partial Response (PR) According to RECIST v1.1 in all Participants

Trial Locations

Locations (1)

Zhi-Ming Shao; 🇨🇳 Shanghai, China