2024-519019-32-00招募中2 期
PREDIX Luminal B - Neoadjuvant response-guided treatment of estrogen receptor positive tumors with high proliferation or slow proliferation with metastatic nodes. Part of a platform of translational phase II trials based on molecular subtypes.
Karolinska University Hospital3 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2024年10月28日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 3
- 主要终点
- Absolute difference in clinical and radiological objective response after completion of the first 12-week period of primary medical treatment
研究概览
简要总结
Evaluate the impact of neoadjuvant endocrine treatment with palbociclib compared with standard chemotherapy on objective response and long- term outcome.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Written informed consent
- •Female or male patients with breast cancer confirmed by histology
- •Tumor and blood samples available. Luminal type confirmed by immunohistochemistry with ER≥10 %, not not HER2 3+/amplified
- •Age 35 years or older. Elderly patients in condition adequate for planned therapy.
- •Primary breast cancer >20 mm in diameter and/or verified regional lymph node metastases
- •Adequate bone marrow, renal, hepatic and cardiac functions and no other uncontrolled medical or psychiatric disorders
- •ECOG performance status 0-1
- •Primary breast cancer as defined in p. 5 plus at most 2 morphologically characterized well- defined distant metastases accessible for stereotactic radiotherapy, provided that this treatment is available.
排除标准
- •Distant metastases, including node metastases in the contralateral thoracic region or in the mediastinum
- •Other malignancy diagnosed within the last five years, except for radically treated basal or squamous cell carcinoma of the skin or CIS of the cervix
- •Patients in child-bearing age without adequate contraception
- •Pregnancy or lactation
- •Uncontrolled hypertension, heart, liver, kidney related or other medical or psychiatric disorders.
结局指标
主要结局
Absolute difference in clinical and radiological objective response after completion of the first 12-week period of primary medical treatment
Absolute difference in clinical and radiological objective response after completion of the first 12-week period of primary medical treatment
次要结局
- Pathological objective response to primary medical treatment
- Sequencing of chemotherapy versus endocrine treatment plus palbociclib
- Morphological, functional and biological characteristics of tumors exposed to cytotoxic and targeted treatment of early breast cancer
- Event-free survival (EFS), invasive disease-free survival (IDFS), distant disease-free survival (DDFS), breast cancer-specific survival (BCSS) and overall survival (OS)
- Safety
- Quality of life
- Frequency of breast-conserving surgery
研究者
Thomas Hatschek
Scientific
Karolinska University Hospital
研究点 (3)
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