AN OPEN-LABEL, PHASE IIIB, SINGLE ARM,MULTICENTER SAFETY STUDY OFATEZOLIZUMAB (TECENTRIQ) PLUS NABPACLITAXEL OR PACLITAXEL IN THETREATMENT OF UNRESECTABLE LOCALLYADVANCED OR METASTATIC TRIPLE-NEGATIVEBREAST CANCER

F. HOFFMANN-LA ROCHE LTD.,0 个研究点目标入组 0 人开始时间: 2019年11月11日最近更新: 2024年8月20日

适应症

试验速览

暂无简介。

•Patients must meet the following criteria for study entry:
•1. Have provided written informed consent.
•2. Female or male ≥ 18 years of age.
•3. Ability to comply with the study protocol, in the investigator’s judgment.
•4. Patients with unresectable locally advanced or metastatic, histologically documented TNBC
•(negative for HER2 and ER and PgR).
•5. Patient with at least one specimen positive for PD-L1 status as determined by VENTANA
•PD-L1 SP142 Assay.
•6. No prior chemotherapy, experimental or targeted systemic therapy for unresectable locally
•advanced or metastatic TNBC.
•7. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
•8. Life expectancy ≥ 12 weeks.
•9. Measurable disease, as defined by RECIST v1.1.
•10. Adequate haematologic and end-organ function, defined by the following laboratory results
•obtained within 14 days prior to the initiation of study treatment (Cycle 1, Day 1).
•See protocol for more detail.

•Patients who meet any of the following criteria will be excluded from study entry:
•Cancer-Specific Exclusion Criteria:
•1. Spinal cord compression not definitively treated with surgery and/or radiation, or previously
•diagnosed and treated spinal cord compression without evidence that disease has been
•clinically stable for > 2 weeks prior to the first dose of study treatment (Cycle 1, Day 1).
•2. Leptomeningeal carcinomatosis or any symptomatic CNS metastases
•3. Uncontrolled symptomatic pleural effusion, pericardial effusion, or ascites
•4. Uncontrolled tumour-related pain
•5. Uncontrolled hypercalcemia (> 1.5 mmol/L ionized calcium or calcium > 12 mg/dL or
•corrected serum calcium > ULN) or symptomatic hypercalcemia requiring continued use of
•bisphosphonate therapy.
•6. Malignancies other than TNBC within 5 years prior to the first dose of study treatment (Cycle
•1, Day 1), with the exception of those with a negligible risk of metastasis or death and
•treated with expected curative outcome (such as adequately treated carcinoma in situ of the
•cervix or basal or squamous cell skin cancer).
•See protocol for more detail.

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