A Phase II, Randomized Study of Paclitaxel Weekly Plus Pembrolizumab Versus Paclitaxel Weekly in ER-positive, Luminal B Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Progression-free survival
研究概览
简要总结
PELICAN is a randomised phase II trial that aims to evaluate the efficacy and safety of paclitaxel plus pembrolizumab relative to paclitaxel alone, in patients with locally advanced or metastatic ER-positive, HER2-negative, Luminal B breast cancer who have received no prior chemotherapy for advanced or metastatic disease.
Patients will be randomised (2:1) to one of the two treatment arms:
- Pembrolizumab plus Paclitaxel
- Paclitaxel
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Willing and able to provide written informed consent
- •Ability to comply with the protocol
- •Female ≥ 18 years of age
- •Histologically confirmed metastatic or locally advanced breast cancer that is Luminal B, ER+ve, HER2-ve.
- •Patients must have measurable disease.
- •Representative formalin-fixed paraffin embedded breast tumour samples from the primary or recurrent cancer.
- •ECOG performance status 0-1
- •Adequate haematologic and end-organ function within 28 days prior to the first study treatment
- •Patients of childbearing potential are eligible provided they have a negative serum or urine pregnancy test on Day 1 Cycle 1 (within 72 hours) of study treatment, preferably as close to the first dose as possible.
排除标准
- •Luminal A breast cancer
- •Prior chemotherapy for advanced or metastatic disease
- •Prior treatment with paclitaxel in the (neo)adjuvant setting within 12 months from the end of paclitaxel treatment and randomisation into this study
- •Patients with neuropathy ≥ Grade 2
- •Previous systemic treatment for other neoplasms within 5 years prior to randomisation.
- •Patients with prior allogeneic stem cell or solid organ transplantation.
- •Prior treatment with CD137 agonists, AKT inhibitors, anti-CTLA-4, anti-OX-40, anti-programmed death-1 (PD-1), or anti-PD-L1 therapeutic antibody or pathway-targeting agents.
- •Patients must not have a diagnosis of immunodeficiency or receiving chronic systemic steroid therapy.
- •Received therapeutic oral or intravenous antibiotics within 14 days prior to randomisation.
- •Administration of a live vaccine within 30 days prior to the first dose of study drug.
- •Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin [IL] -2) within 28days or five half-lives of the drug, whichever is shorter, prior to randomisation.
- •History of autoimmune disease.
- •History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, organizing pneumonia requiring steroids, or evidence of active pneumonitis on screening chest CT scan.
- •Active infection requiring systemic therapy.
- •History of HIV infection
- •Known active hepatitis infection.
- •Known history of active tuberculosis
研究组 & 干预措施
Pembrolizumab + Paclitaxel
200 mg Pembrolizumab IV Q3W plus 80 mg/m2 paclitaxel IV on Days 1,8, and 15 of each 28 day cycle.
干预措施: Pembrolizumab (Drug)
Pembrolizumab + Paclitaxel
200 mg Pembrolizumab IV Q3W plus 80 mg/m2 paclitaxel IV on Days 1,8, and 15 of each 28 day cycle.
干预措施: Paclitaxel (Drug)
Paclitaxel
80 mg/m2 paclitaxel IV on Days 1,8, and 15 of each 28 day cycle.
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Progression-free survival
时间窗: At 12months
Progression-free survival, defined as the time from the date of randomisation to the date of first documented tumour progression (using RECIST 1.1) or death from any cause, whichever occurs first.
Overall Survival
时间窗: At 24 months.
Overall Survival is defined as the time from date of randomisation to the date of death due to any cause in all patients.
次要结局
- Objective Response Rates(Date of first documentation of CR or PR or to the date of first documented tumour progression (using RECIST 1.1) or death from any cause, whichever occurs first, assessed up to 30 months.)
- Safety and tolerability of paclitaxel plus pembrolizumab versus paclitaxel through review of all AEs and SAEs assessed by CTCAE v4.03(Date of randomisation to date of all adverse event resolution following discontinuation for any reason or death, assessed up to 30 months.)