Randomised Phase II clinical trial PIONEER- A Pre-operative wIndOw study of letrozole plus PR agonist (Megestrol Acetate) versus letrozole aloNE in post-menopausal patients with ER-positive breast cancer - PIONEER

Cambridge University Hospitals NHS Foundation Trust and University of Cambridge0 个研究点目标入组 189 人开始时间: 2018年5月3日最近更新: 2019年12月16日

适应症

试验速览

暂无简介。

•Inclusion Criteria
•To be included in the trial the patient must:
•Histologically confirmed breast adenocarcinoma
•Postmenopausal women, defined as having experienced:
•-12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. =50 years, history of vasomotor symptoms) or
•-six months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL and estradiol < 20 pg/mL or
•-surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago.
•Core biopsy confirmation of ER positive (Allred=3) and HER2 negative invasive carcinoma on core biopsy, >=T1c, either cN0 or N+
•Patients whose cancers have been deemed to be operable by the MDT
•Surgery planned within the next 2-6 weeks
•ECOG performance status of 0, 1 or 2
•Adequate Liver, Renal and Bone marrow function, defined as:
•-Adequate liver function where bilirubin is =1.5 x ULN
•-Adequate renal function with estimated creatinine clearance of =60 ml/min
•-Adequate bone marrow function with ANC =1.0 x 109/L and Platelet count =100 x 109/L
•Written informed consent to participate in the trial and to donation of tissue
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 75
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 114

•Exclusion Criteria
•The presence of any of the following will preclude patient inclusion:
•History of hormone replacement therapy in the last 6 months
•Previous treatment with tamoxifen or an aromatase inhibitor in the last six months
•Known hypersensitivity or contraindications to aromatase inhibitors or megestrol acetate
•Known allergy to lactose
•Known to have a progestogen-containing intrauterine system in situ, unless removed prior to randomisation
•Known metastatic disease on presentation
•Recurrent breast cancer (patients with a new primary invasive breast cancer will be eligible to participate)
•Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator
•Treatment with an investigational drug within 4 weeks before randomization
•Inability to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the trial medication
•Inability to give informed consent

发起方

Cambridge University Hospitals NHS Foundation Trust and University of Cambridge