Famitinib in Combination With Camrelizumab and TPC in The First-line Treatment of Immunomodulatory Locally Advanced or Metastatic TNBC.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Famitinib, Camrelizumab, nab-Palitaxel/Capecitabine/Eribulin Mesylate/Carboplatin.
- Who it may be relevant to
- Registry conditions: Triple-Negative Breast Cancer. Basic parameters: 18 years — 70 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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
- Drug Famitinib
TKI - Drug Camrelizumab
PD1 inhibitor - Drug nab-Palitaxel/Capecitabine/Eribulin Mesylate/Carboplatin
TPC
Primary outcome measures
- PFS [Time frame: 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)]
Secondary outcome measures (4)
- ORR [Time frame: max 6 months]
- DoR [Time frame: max 6 months]
- CBR [Time frame: max 6 months]
- OS [Time frame: approximately 3 years]
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 .
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Breast cancer institute of Fudan University Cancer Hospital — Shanghai
Identifiers
NCT: NCT05760378 · BCTOP-T-M02