NL-OMON54814招募中2 期
Pre-operative phase II trial for breast cancer with nivolumab in combination with novel IO (BELLINI trial) - BELLINI
ederlands Kanker Instituut0 个研究点目标入组 90 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
- 90
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 64（—）
入选标准
- •Resectable primary breast cancer stage I-III. Nodal status must be examined
- •by ultrasound, fine needle aspiration, sentinel node biopsy, or FDG-PET scan
- •(cohort 3B, 4B and 5B4: PET-CT mandatory).
- •- Patients indicated for neoadjuvant chemotherapy will also be eligible,
- •whereby a new dedicated biopsy is performed before the beginning of the
- •chemotherapy. Adjuvant systemic treatment is allowed if indicated according to
- •local guidelines.
- •Tumor size at least 5 mm (minimum cT1b) as determined by MRI
- •TNBC defined as ER<10%, HER2-negative OR luminal B defined as ER>=10%,
- •HER2-negative with either Ki67>=20% or PR <=20% OR grade 3. HER2 negative is
- •defined as an IHC score of <2 or 2+ with a negative ISH.
- •- For TNBC patients: TIL>=5%
- •- For LumB breast cancer patients: TIL>=1%
- •- For cohort 3B: N0 status, TNBC and TIL >=1%
- •- For cohort 4B: N0 status, TNBC and TIL >=30-49%
- •- For cohort 5B: N0 status, TNBC and TIL >=50%
- •Age >=18
- •WHO performance status <=1
排除标准
- •evidence or suspicion of metastatic disease. Evaluation of the presence of
- •distant metastases may include chest X-ray, liver ultrasound, isotope
- •bone-scan, CT-scan of chest and abdomen and/or FDG-PET scan, according to local
- •procedures;
- •other prior invasive malignancy 1) in the breast or 2) localized in the near
- •proximity of the breast, that was treated with radiotherapy at the
- •localization of the new breast tumor;
- •Concurrent ipsilateral or contralateral disease of the primary or a secondary
- •tumor is allowed, as long as the other lesions is not a distant metastasis.
- •Locoregional recurrences are not allowed. Second primary tumors are allowed
- •in the study;
- •occult breast cancer;
- •previous anti-cancer hormone therapy or chemotherapy;
- •prior treatment with checkpoint inhibitors (including anti- PD1, -PD-L1,
- •-CTLA-4 - LAG3);
- •concurrent anti-cancer treatment, neoadjuvant therapy or another
- •investigational drug;
研究者
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