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)

NCT ID: NCT04129996

Last Updated: 2022-01-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2022-09-01

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..

Conditions

Triple-Negative Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

camrelizumab in combination with nab-paclitaxel and famitinib

Group Type: EXPERIMENTAL

camrelizumab in combination with nab-paclitaxel and famitinib

Intervention Type: DRUG

camrelizumab in combination with nab-paclitaxel and famitinib for triple negative breast cancer

Interventions

camrelizumab in combination with nab-paclitaxel and famitinib

camrelizumab in combination with nab-paclitaxel and famitinib for triple negative breast cancer

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Zhimin Shao

clinical professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

zhimin shao, MD,PHD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Zhi-Ming Shao

Shanghai, , China

Countries

China

References

Wu SY, Xu Y, Chen L, Fan L, Ma XY, Zhao S, Song XQ, Hu X, Yang WT, Chai WJ, Guo XM, Chen XZ, Xu YH, Zhu XY, Zou JJ, Wang ZH, Jiang YZ, Shao ZM. Combined angiogenesis and PD-1 inhibition for immunomodulatory TNBC: concept exploration and biomarker analysis in the FUTURE-C-Plus trial. Mol Cancer. 2022 Mar 25;21(1):84. doi: 10.1186/s12943-022-01536-6.

Reference Type: DERIVED

PMID: 35337339 (View on PubMed)

Chen L, Jiang YZ, Wu SY, Wu J, Di GH, Liu GY, Yu KD, Fan L, Li JJ, Hou YF, Hu Z, Chen CM, Huang XY, Cao AY, Hu X, Zhao S, Ma XY, Xu Y, Sun XJ, Chai WJ, Guo X, Chen X, Xu Y, Zhu XY, Zou JJ, Yang WT, Wang ZH, Shao ZM. Famitinib with Camrelizumab and Nab-Paclitaxel for Advanced Immunomodulatory Triple-Negative Breast Cancer (FUTURE-C-Plus): An Open-Label, Single-Arm, Phase II Trial. Clin Cancer Res. 2022 Jul 1;28(13):2807-2817. doi: 10.1158/1078-0432.CCR-21-4313.

Reference Type: DERIVED

PMID: 35247906 (View on PubMed)

Other Identifiers

SCHBCC-N025

Identifier Type: -

Identifier Source: org_study_id