A Trial Exploring the Opportune Administration of Nab-paclitaxel in the First Line Treatment, Camrelizumab Combined With Nab-paclitaxel and Famitinib, of TNBC.

Fudan University

Status and phase

Enrolling

Phase 2

Conditions

Triple-Negative Breast Cancer

Treatments

Drug: Camrelizumab plus Famitinib with/without nab-Palitaxel

Study type

Interventional

Funder types

Other

Identifiers

NCT05670925

C-plus-Pairs

Details and patient eligibility

About

The study is being conducted to evaluate the Opportune Administration of Nab-paclitaxel in the First Line Treatment Strategy, Camrelizumab and Famitinib with/without Nab-paclitaxel, of Patients with Unresectable Locally Advanced or Metastatic Immunomodulatory Triple Negative Breast Cancer.

Enrollment

46 estimated patients

Sex

Female

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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 ;