An Open, Randomized Phase III Study of Famitinib With Camrelizumab Plus Treatment of Physician's Choice (TPC) Versus Camrelizumab Plus TPC in The First-line Treatment of Immunomodulatory Locally Advanced or Metastatic Triple-negative Breast Cancer

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The study is being conducted to evaluate the Famitinib with Camrelizumab plus treatment of physician's choice (TPC) versus Camrelizumab plus TPC in Patients with Unresectable Locally Advanced or Metastatic Immunomodulatory Triple Negative Breast Cancer.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Breast cancer institute of Fudan University Cancer Hospital
RECRUITING
Shanghai
Contact Information
Primary
Zhimin Shao
zhimingshao@yahoo.com
86-021-64175590
Time Frame
Start Date: 2023-03-17
Estimated Completion Date: 2027-01-01
Participants
Target number of participants: 223
Treatments
Experimental: A
Famitinib in Combination With Camrelizumab and TPC
Active_comparator: B
Combination With Camrelizumab and TPC
Related Therapeutic Areas
Sponsors
Leads: Fudan University

This content was sourced from clinicaltrials.gov

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