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Trial Title:
Famitinib in Combination With Camrelizumab and TPC in The First-line Treatment of Immunomodulatory Locally Advanced or Metastatic TNBC.
NCT ID:
NCT05760378
Condition:
Triple-Negative Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Carboplatin
Capecitabine
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Famitinib
Description:
TKI
Arm group label:
A
Intervention type:
Drug
Intervention name:
Camrelizumab
Description:
PD1 inhibitor
Arm group label:
A
Arm group label:
B
Intervention type:
Drug
Intervention name:
nab-Palitaxel/Capecitabine/Eribulin Mesylate/Carboplatin
Description:
TPC
Arm group label:
A
Arm group label:
B
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.
Criteria for 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 .
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Breast cancer institute of Fudan University Cancer Hospital
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhi-Ming Shao, MD
Phone:
86-21-641755901105
Email:
zhimingshao@yahoo.com
Contact backup:
Last name:
Lei Fan, MD
Phone:
86-21-641755901105
Email:
cmchen@medmail.com.cn
Investigator:
Last name:
Zhi-Ming Shao, MD
Email:
Principal Investigator
Investigator:
Last name:
Lei Fan, MD
Email:
Sub-Investigator
Investigator:
Last name:
Wenjuan Zhang, MD
Email:
Sub-Investigator
Investigator:
Last name:
Ying Zhou
Email:
Sub-Investigator
Start date:
March 17, 2023
Completion date:
January 1, 2027
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05760378
