NL-OMON52986招募中2 期
Biomarker discovery randomized phase IIb trial with carboplatin-cyclophosphamide versus paclitaxel with or without Bevacizumab as first-line treatment in advanced triple negative Breast cancer (TRIPLE-B study);Title after protocol amendment August 12, 2017: Biomarker discovery randomized phase IIb trial with carboplatin-cyclophosphamide versus paclitaxel with or without atezolizumaB as first-line treatment in advanced triple negative Breast cancer (TRIPLE-B study) - TRIPLE-B study
BOOG Study Center0 个研究点目标入组 304 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 304
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Histologically confirmed triple negative metastasized or locally advanced
- •incurable breast cancer. See protocol section 5.2 for more details.
- •- Histological confirmation of triple negative breast cancer of a metastatic
- •recommended
- •- Histological or cytological confirmation of metastatic breast cancer is
- •required in case of
- •normal CA 15.3 levels. Exception: see protocol section 5.2 for details.
- •- Primary tumor or metastasis tissue sent to NKI-AVL for BRCA-like testing
- •- Pretreatment histological biopsy of a metastatic lesion for the
- •translational research
- •questions (tumor tissue from bone metastases cannot be used). Exception: see
- •protocol section 5.2 for details.
- •- No previous cytotoxic therapy for metastatic disease
- •- Disease-free interval of at least 12 months after completion of (meo)adjuvant
- •paclitaxel or (neo)adjuvant platinum compound
- •- Disease-free interval of at least 6 months after completion of (neo)adjuvant
- •- Measurable or evaluable disease according to RECIST v1.1
- •- WHO performance status of 0 or 1
排除标准
- •- Receptor conversion to hormone receptor positive (defined as >= 10% ER
- •positive tumor cells) or HER2 positive
- •- Other antitumor therapy within the previous 21 days with the exception of
- •recently started (within 21 days of randomization) endocrine therapy.
- •- Radiotherapy with palliative intent within the previous 7 days before start
- •study medication (see protocol 5.3 for details)
- •- Known CNS disease except for treated brain metastases (see protocol 5.3 for
- •- Pre-existing peripheral neuropathy > grade 1 (NCI-CTC AE (version 4.03) at
- •- Use of denosumab is not allowed. See protocol section 5.3 for details.
- •- Severe infection in the last 4 weeks.
- •- Antibiotics in the last 2 weeks.
- •- History of autoimmune disease. See protocol section 5.3 for details.
- •- Prior allogeneic stem cell or solid organ transplantation
- •- History of lung diseases such as idiopathic pulmonary fibrosis, pneumonitis.
- •See protocol section 5.3 for more details
- •- An infection requiring parenteral antibiotic
- •- Positive test for hepatitis B, C HIV. See protocol section 5.3 for more
- •- Active tuberculosis.
- •- Live, attenuated vaccine within 4 weeks prior to randomization.
- •- Prior treatment with anti cancer vaccins or immune checkpoint blockade
- •therapies, including anti-CTLA-4, CD137 agonist, OX40 agonist, anti-PD-1, or
- •anti-PD-L1 therapeutic antibodies
- •- Treatment with systemic immunostimulatory agents, systemic corticosteroids or
- •other systemic immunosuppressive medications. See protocol section 5.3 for
研究者
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