A Prospective, Single-arm, Open-Label, Phase II Study of Nab-paclitaxel Plus Cisplatin Plus Carilizumab as First-line Treatment in Patients With Metastatic Triple-negative Breast Cancer

Who is this study for? Patients with Breast Cancer
What treatments are being studied? Nab-Paclitaxel+Cisplatin+Carilizumab (AP+PD-1)
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

To evaluate the efficacy and safety of nab-paclitaxel plus cisplatin plus carilizumab as first-line treatment in patients with metastatic triple-negative breast cancer.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Female patients aged 18-70 years who had

• Metastatic TNBC. ER, PgR, and HER2 status were determined locally by immunohistochemistry (IHC) of patient primary or metastatic tumor sections. Metastatic disease was confirmed by clinical, imaging, histological or cytological measures.

• Patients were required to receive no previous chemotherapy or targeted therapy for metastatic triple-negative breast cancer.

• Patients who had received adjuvant/neoadjuvant therapy were required an interval for at least 6 months after stop of chemotherapy before the enrollment.

• At least one measurable lesion according to RECIST 1.1,

• ECOG performance status ≤ 1

• Life expectancy of more than 12 weeks

• Adequate organ and bone marrow function.

Locations
Other Locations
China
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Contact Information
Primary
Biyun Wang, Professor
pro_wangbiyun@163.com
+8613701748410
Time Frame
Start Date: 2020-08-25
Estimated Completion Date: 2024-10-15
Participants
Target number of participants: 90
Treatments
Experimental: nab-paclitaxel plus cisplatin plus carilizumab (AP+PD-1)
Nab-paclitaxel 125 mg/m2,ivgtt,d1, 8 Cisplatin 75 mg/m2,ivgtt,d1 Carilizumab 200mg, ivgtt,d1,q2w
Related Therapeutic Areas
Sponsors
Leads: Fudan University

This content was sourced from clinicaltrials.gov

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