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

  • STATUS
    Recruiting
  • End date
    Feb 28, 2022
  • participants needed
    660
  • sponsor
    Shanghai Junshi Bioscience Co., Ltd.
Updated on 24 January 2021
paclitaxel
cancer
estrogen
measurable disease
breast cancer
growth factor
progesterone
HER2
human epidermal growth factor
triple negative breast cancer
progesterone receptor
erbb2
epidermal growth factor
taxane
triple-negative breast cancer
mammogram

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).

Details
Condition Breast Cancer, Diet and Nutrition, Chronic Diarrhea, Skin Wounds, Chronic Shoulder Pain, Vaginal Atrophy, Adverse Effects, Drugs, Injection Port, Breast Cancer - HER2 Positive, Anal Dysplasia, Primary Immunodeficiency, Pediatric Health, Near-Sighted Corrective Surgery, Peripheral Arterial Occlusive Disease, Triple Negative Breast Cancer, Brain Function, Recurrent Respiratory Papillomatosis, Razor Bumps (Pseudofolliculitis Barbae), Metastatic Triple-Negative Breast Cancer
Treatment Placebo, Nab-paclitaxel, JS001
Clinical Study IdentifierNCT04085276
SponsorShanghai Junshi Bioscience Co., Ltd.
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

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
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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