A Trial Exploring the Opportune Administration of Nab-paclitaxel in the First Line Treatment, Camrelizumab Combined With Nab-paclitaxel and Famitinib, of TNBC.
NCT05670925 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46
Last updated 2023-02-28
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.
Conditions
- Triple-Negative Breast Cancer
Interventions
- DRUG
-
Camrelizumab plus Famitinib with/without nab-Palitaxel
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.
Sponsors & Collaborators
-
Fudan University
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-03-01
- Primary Completion
- 2023-09-01
- Completion
- 2023-09-01
Countries
- China
Study Locations
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