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)

NCT04129996 | Unknown Phase 2

• 1 other identifier: SCHBCC-N025
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

camrelizumab in combination with nab-paclitaxel and famitinib

EXPERIMENTAL

Drug: camrelizumab in combination with nab-paclitaxel and famitinib

Interventions

camrelizumab in combination with nab-paclitaxel and famitinib DRUG

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

camrelizumab in combination with nab-paclitaxel and famitinib

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Zhi-Ming Shao

Shanghai, 200032, China

Location

Related Publications (2)

• 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.

  PMID: 35337339 DERIVED

• 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.

  PMID: 35247906 DERIVED

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

camrelizumab; 130-nm albumin-bound paclitaxel; famitinib

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• zhimin shao, MD,PHD

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical professor

Study Record Dates

• First Submitted: October 11, 2019
• First Posted: October 17, 2019
• Study Start: October 1, 2019
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: January 11, 2022

Record last verified: 2022-01

Locations

CN (1)