NL-OMON52225招募中不适用
The use of single cell genomics to identify chromosomal alterations driving resistance to palbociclib in metastatic breast cancer patients - PALETTE
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Adult women (>= 18 years of age) with proven diagnosis of adenocarcinoma of
- •the breast with locoregional recurrent or metastatic disease not amenable to
- •resection or radiation therapy with curative intent.
- •2. Documentation of histologically or cytologically confirmed diagnosis of
- •estrogen receptor (ER) expression >10% and/or progesterone receptor (PR)
- •expression >10% breast cancer based on local laboratory results. Tumor must be
- •HER2-negative as defined by ASCO-CAP guidelines (ref).
- •3. Patients starting the combination endocrine therapy + palbociclib as first
- •or a subsequent treatment line for metastatic disease.
- •4. Patients must have evaluable disease as per RECIST v.1.1.
- •5. Evidence of a personally signed and dated informed consent document
- •indicating that the patient has been informed of all pertinent aspects of the
- •study before any study-specific activity is performed.
排除标准
- •1. Pre-existing lymphedema in one or both arms, diagnosed by the treating
- •medical oncologist
- •2. Patients with known hypersensitivity to the anticoagulant used for apheresis
- •3. Patients with inadequate cardiac function or severe cardiovascular
- •comorbidity:
- •- Heart failure NYHA class III/IV
- •4. Hemoglobin level < 6.0 mmol/L
- •5. Coagulation disorders as defined by one of the following
- •- Coagulation disorder in medical history
- •- Platelet count < 40 x 109/L;
- •Patients without anticoagulant therapy which affects PT or APTT, when:
- •- PT > 1.5 x ULN or PT-INR > 1.5 x ULN
- •- APTT > 1.5 x ULN
- •Patients with anticoagulant therapy which affects PT or APTT, when:
- •- PT or APTT > 1.5 x the upper limit of the desired therapeutic window
- •- Total bilirubin >2.5 x ULN
- •6. Known chronic viral infections
- •7. Patients with a history of any other cancer, unless in complete remission
- •requiring no active treatment, are excluded
研究者
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