Toripalimab in Combination With Nab-Paclitaxel For Patients With Metastatic or Recurrent Triple-Negative Breast Cancer (TNBC) With or Without Systemic Treatment
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Keep this study
Lead
Shanghai Junshi Bioscience Co., Ltd.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
Clareo Health | Toripalimab in Combination With Nab-Paclitaxel For Patients With Metastatic or Recurrent Triple-Negative Breast Cancer (TNBC) With or Without Systemic Treatment
