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Trial Title:
A Trial Exploring the Opportune Administration of Nab-paclitaxel in the First Line Treatment, Camrelizumab Combined With Nab-paclitaxel and Famitinib, of TNBC.
NCT ID:
NCT05670925
Condition:
Triple-Negative Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Camrelizumab plus Famitinib with/without nab-Palitaxel
Description:
After enrollment confirmed, the regimen of Camrelizumab Combined with Famitinib will be
conducted for 2 cycles (8 weeks). Patients of CR or PR after 2 cycles (8 weeks) will
enter dual-therapy maintenance phase until disease progression and will be recorded as
PFS-1α. Patients of PD after 2 cycles (8 weeks) will be recorded as PFS-1β. Patients of
SD with 2 cycles of dual therapy wlii receive triple therapy regimen: Camrelizumab and
Famitinib with nab-Paclitaxel.
Arm group label:
Camrelizumab plus Famitinib with/without nab-palitaxel
Summary:
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.
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
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan University Shanghai Cancer Center Shanghai, China, 200032
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhimin Shao, M.D.
Phone:
+86-021-64175590
Phone ext:
88807
Email:
zhimingshao@yahoo.com
Contact backup:
Last name:
Min He, M.D
Phone:
+86-021-64175590
Phone ext:
88603
Email:
minsmiler@126.com
Start date:
March 1, 2023
Completion date:
September 1, 2023
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/NCT05670925
