Status:
ACTIVE_NOT_RECRUITING
Toripalimab in Combination With Nab-Paclitaxel For Patients With Metastatic or Recurrent Triple-Negative Breast Cancer (TNBC) With or Without Systemic Treatment
Lead Sponsor:
Shanghai Junshi Bioscience Co., Ltd.
Conditions:
Triple-Negative Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
This multicenter, randomized, double-blind study will evaluate the efficacy and safety of Toripalimab (JS001) combined with nab-paclitaxel compared with placebo combined with nab-paclitaxel for first/...
Eligibility Criteria
Inclusion
- Metastatic or recurrent triple negative breast cancer (TNBC);
- Histologically confirmed diagnosis of TNBC characterized by estrogen-receptor negative (ER-), progesterone receptor negative (PR-) and human epidermal growth factor-2 receptor negative (HER2-);
- Eligible for taxane monotherapy;
- No more than one line of chemotherapy in metastatic setting;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Life expectancy of 12 weeks or more;
- At least one measurable lesion per RECIST v1.1;
- Demonstrate adequate hematologic and organ functions as defined in the protocol
Exclusion
- Prior treatment with taxane as first line treatment;
- Prior treatment with PD-1 antibody, PD-L1 antibody, PD-L2 antibody, or CTLA4 antibody (or any other antibody acting on T cell co-stimulation or checkpoint pathway)
- MRI assessment during screening or previous imaging studies confirmed active or untreated brain metastases. Patients previously treated with local treatment of brain metastases has been stable for ≥ 1 month, and have stopped systemic hormonal therapy (\>10 mg/d prednisone or equivalent) \> 4 weeks before randomization can participate in the study;
- Meningeal carcinomatosis;
- Pregnancy or lactation;
- Active hepatitis B or hepatitis C.
Key Trial Info
Start Date :
December 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
531 Patients enrolled
Trial Details
Trial ID
NCT04085276
Start Date
December 21 2018
End Date
December 31 2025
Last Update
June 11 2025
Active Locations (53)
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1
The Fifth Medical Center of PLA General Hospital
Beijing, Beijing Municipality, China, 100071
2
Beijing Hospital
Beijing, Beijing Municipality, China
3
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
4
Peking University Shougang Hospital
Beijing, Beijing Municipality, China