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)

Triple-Negative Breast Cancer Clinical Trial

Official title:

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: An Open, Single-arm, Multicenter, Efficacy and Safety Phase II Clinical Study.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04129996
• Other study ID #: SCHBCC-N025
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: October 1, 2019
• Est. completion date: September 1, 2022

Study information

• Verified date: January 2022
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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..

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 46
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Triple Negative Breast Neoplasms
• Triple-Negative Breast Cancer

Intervention

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

Locations

Country	Name	City	State
China	Zhi-Ming Shao	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR	Percentage of Participants With an Objective Response of Complete Response (CR) or Partial Response (PR) According to RECIST v1.1 in all Participants	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