eoadjuvant trastuzumab, pertuzumab and tucatinib without chemotherapy in HER2-positive breast cancer: the TRAIN-4 study - TRAIN-4

Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 30 人开始时间: 待定最近更新: 2024年4月9日

适应症

试验速览

暂无简介。

•1. Signed written informed consent 2. Histologically confirmed primary invasive
•breast cancer 3. Stage II - IIIA primary breast cancer according to TNM-staging
•(8th edition, AJCC); (largest tumor diameter DCE-MRI >= 2cm (cT2-3) and/or cN1-2
•confirmed with FNA or histology) 4. HER2 overexpression defined as
•circumferential membrane staining that is complete, intense and in >10% of
•invasive tumor cells (IHC 3+) on pre-treatment biopsy 5. Known estrogen- and
•progesterone-receptor expression of the invasive tumor a. ER-negative or
•PR-negative is defined as <10% of invasive tumor cell nuclei are
•immunoreactive in the presence of evidence that the sample can express ER
•and/or PR 6. WHO performance status 0-1 7. Age (>= 18 years of age) 8. LVEF >=50%
•measured by echocardiography or MUGA 9. Eligible for neoadjuvant treatment 10.
•Laboratory requirements within 21 days prior to enrollment: a. Adequate bone
•marrow function (ANC >=1.5 x 109/l, platelets >=100 x 109/l); b. Adequate hepatic
•function (ALAT, ASAT and bilirubin <=2.5 times upper limit of normal). Subjects
•with Gilbert's syndrome may have a total bilirubin >=2.5 × the ULN range, if no
•evidence of biliary obstruction exists; c. Adequate renal function: creatinine
•clearance >50 ml/min estimated using the Cockcroft-Gault equation or MDRD
•equation, or based on a 24-hour urine collection measurement

•1. Current pregnancy or breastfeeding
•2. Current or previous other malignancy unless treated without systemic therapy
•and more than five years ago
•3. Psychological, familial, sociological, or geographical condition potentially
•hampering compliance with the study protocol and follow-up schedule
•4. Use of a strong CYP3A4 or CYP2C8 inhibitor within five half-lives of the
•inhibitor, or used a strong CYP3A4 or CYP2C8 inducer within five days prior to
•first dose of study treatment
•5. Known chronic liver disease
•6. History of inflammatory bowel disease or bowel resection
•7. Contraindications for MRI
•8. Inflammatory breast cancer, cT4 and/or cN3 tumors
•9. Occult breast cancer (cT0)

发起方

Antoni van Leeuwenhoek Ziekenhuis