EUCTR2020-005200-19-SE招募中1 期
se of Imatinib to convert triple negative breast cancer into ER-positive breast cancer - I-CONIC - I-CONIC
Västra Götalandsregionen/Onkologiska kliniken0 个研究点目标入组 40 人开始时间: 2020年12月18日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
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
- 性别
- All
入选标准
- •Inclusion criteria
- •Histologically confirmed invasive primary triple negative breast cancer =15 mm with any node status.
- •Age =18 years old.
- •Triple negative subtype is defined below:
- •oHormone receptor status: the invasive tumour shall be ER- and PR-negative [staining present in <10% by immunohistochemistry (IHC)].
- •oHER2 status: the invasive tumour shall be HER2-negative by the ASCO CAP guidelines
- •No previous systemic treatment for TNBC.
- •No concurrent anti-cancer treatment.
- •Treatment with Bisphosphonates may continue.
- •ECOG performance status 0-1
- •Normal organ function as defined below:
- •oabsolute white blood cell count =1.5 x 109/L
- •oplatelets =100 x 109/L
- •ohaemoglobin =90g/dL
- •ototal bilirubin =1.5 x institutional UNL/dL (= 3 x UNL for patients with Gilbert´s syndrome)
- •oASAT, ALAT, GGT and alkaline phosphatase levels < 1.5 × institutional ULN.
- •oalbumin >2.5mg/dL
- •oCreatinine < 110 µmol/L
- •oT3, T4 and TSH (only patients with previous thyroid dysfunction)
- •Patients of childbearing potential must have a negative serum or urine pregnancy test within 8 days of initiating imatinib therapy.
- •Female patients of childbearing potential must agree to use contraceptive methods with a failure rate below 1% per year during the study treatment and at least 90 days after the last dose of imatinib.
- •Patients must be able to take (swallow) an oral medication.
- •Patients must be capable to understand and comply with the protocol and has signed the informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Exclusion criteria
- •HER2 positive or luminal (ER/PgR positive) breast cancer.
- •Concomitant treatment for breast cancer within 14 days before registration.
- •Unable to adhere to the study procedures.
- •Evidence of any other medical conditions (such as psychiatric illness, infectious diseases, neurological conditions, physical examination or laboratory findings) that may interfere with the planned treatment or affect patient compliance.
- •Pregnancy and breast feeding.
- •Concurrent malignancy requiring therapy (excluding non-invasive carcinoma or carcinoma in situ and a cancer diagnosed and definitively treated = 5 years before randomization with no subsequent evidence of recurrence.
- •Known human immune deficiency positivity.
- •Known active Hepatitis B or Hepatitis C.
研究者
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