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

Shanghai Junshi Biosciences

Status and phase: Active, not recruiting; Phase 3

Conditions: Triple-Negative Breast Cancer

Treatments: Drug: Nab-Paclitaxel; Drug: Placebo; Drug: JS001

Study type: Interventional

Funder types: Other

Identifiers

NCT04085276

JS001-026-III-TNBC

Details and patient eligibility

About

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).

Enrollment: 531 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

531 participants in 2 patient groups, including a placebo group

JS001 Plus Nab-Paclitaxel

Experimental group

Description:

Patients will receive both JS001 and Nab-Paclitaxel.

Treatment:

Drug: JS001

Drug: Nab-Paclitaxel

Drug: Nab-Paclitaxel

Placebo Plus Nab-Paclitaxel

Placebo Comparator group

Description:

Patients will receive both placebo and Nab-Paclitaxel.

Treatment:

Drug: Placebo

Drug: Nab-Paclitaxel

Drug: Nab-Paclitaxel