Triple-Negative Breast Cancer
Conditions
Brief 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.
Interventions
DRUGFamitinib
TKI
DRUGCamrelizumab
PD1 inhibitor
DRUGnab-Palitaxel/Capecitabine/Eribulin Mesylate/Carboplatin
TPC
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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 .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 1.5 years) | time to progressive disease (according to RECIST1.1) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ORR | max 6 months | The proportion of participants whose best outcome is complete remission or partial remission (according to RECIST1.1) |
| DoR | max 6 months | Duration of Overall Response.The date of the first assessed PR/CR (according to RECIST 1.1) to the date of the first assessed tumor progression (according to RECIST 1.1) or death from any cause. |
| CBR | max 6 months | The percentage of subjects with CR+PR+SD and last more than 24 weeks in all of the participants. |
| OS | approximately 3 years | time to death due to any cause |
Countries
China
Contacts
Primary ContactZhimin Shao
Outcome results
None listed