EUCTR2011-004220-34-GB进行中（未招募）1 期
A randomised phase II trial of [18F]fluorothymidine and the standard tracer [18F]Fluorodeoxyglucose in the assessment of systemic therapy response in triple negative breast cancer and their utility compared to conventional MRI imaging response, early ADC change and biopsy derived biomarkers - TNBC:Novel functional imaging to determine early chemotherapy response
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 22
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Female age 18 to 70 years
- •Women of childbearing potential must have documented negative pregnancy test within the 2 weeks prior to day 1 chemotherapy and agree to use a medically acceptable birth control during the duration of their chemotherapy.
- •Stage II-III biopsy proven early breast cancer for which primary chemotherapy is recommended. Staging performed in accordance with local protocols.
- •All patients will have HER2 negative primary tumours (IHC 0 or 1+, or IHC 2+ and FISH non-amplified (ratio of Her2 to chromosome 17 of more than 2.0)
- •All patients will have ER negative primary invasive breast cancer (Allred <3)
- •ECOG PS of 0 or 1
- •Primary tumour size >2cm
- •Eligible for neoadjuvant chemotherapy according to departmental protocols
- •Written informed consent
- •Able to comply with treatment plans, scheduled visits, all study PET imaging and biopsy procedures and follow-up
- •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 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •Any prior treatment for the breast cancer
- •Patients who are pregnant will be excluded.
- •Patients who are breast feeding
- •Evidence of metastasic disease at diagnosis precluding neoadjuvant chemotherapy.
- •Requirement for concurrent radiotherapy treatment
- •Serious medical condition or concurrent medical illness likely to compromise ability to complete prescribed chemotherapy course.
- •Anticoagulation requirement which would preclude serial biopsy
- •Diabetes Mellitus
- •Any other problems that may make the patient unable to tolerate the PET scans or translational biopsies
- •Investigational Medicinal Product in the previous 28 days
研究者
相似试验
已完成
2 期
Study of Clinical Usefulness of 18F-fluorothymidine(FLT) PET/CT in Ditection of Peritoneal Metastases of Gastric CancerJPRN-UMIN000009329Department of Gastrointestinal Oncology, National Cancer Center Hospital in Japan40
已完成
2 期
Phase 2/3 study of fluoropyrimidine and irinotecan plus bevacizumab versus trifluridine/tipiracil plus bevacizumab as second-line for metastatic colorectal cancer (TRUSTY)JPRN-jRCT1080223562Taiho Pharmaceutical Co., Ltd.524
招募中
2 期
Oxaliplatin ± nivolumab in combination with trifluridine/tipiracil or 5- fluorouracile ± nivolumab in frail patients with advanced, recurrent or metastatic gastric, oesophageal or gastroesophageal junction cancer2024-512999-35-00Unicancer118
招募中
2 期
tility of 18F-fluorocholine positron emission tomography in prostate cancer.Cancer - ProstateProstate cancerACTRN12608000641392Peter MacCallum Cancer Centre100
进行中（未招募）
不适用
A randomised clinical trial of treatment for fluorouracil-resistant advanced colorectal cancer comparing standard single-agent irinotecan versus irinotecan plus panitumumab and versus irinotecan plus ciclosporin - PICCOLO: Panitumumab, Irinotecan & Ciclosporin in Colorectal cancer therapyEUCTR2005-003492-20-GBniversity of Leeds1,324