Overview

Toripalimab in Combination With Nab-Paclitaxel For Patients With Metastatic or Recurrent Triple-Negative Breast Cancer (TNBC) With or Without Systemic Treatment

Status:
Recruiting
Trial end date:
2022-02-28
Target enrollment:
0
Participant gender:
Female
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/second line treatment of metastatic or recurrent triple-negative breast cancer (TNBC).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Shanghai Junshi Bioscience Co., Ltd.
Treatments:
Albumin-Bound Paclitaxel
Paclitaxel
Criteria
Inclusion Criteria:

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 Criteria:

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.