An open-label, randomized, window of opportunity study between diagnosis and definite surgery, to assess the effect of antiestrogen therapies, alone and in combination with microionized progesterone (prometrium) in patients with newly diagnosed ER+PR+ breast cancer.

St Vincent's Hospital, Sydney0 个研究点目标入组 200 人开始时间: 2018年6月1日最近更新: 2019年7月15日

适应症

试验速览

暂无简介。

•1. Post-menopausal women defined by any one of the following criteria;
•a) Amenorrhea >12 months at the time of diagnosis and an intact uterus, with FSH and estradiol in the postmenopausal ranges,
•b) prior bilateral oophorectomy, and
•c) FSH and estradiol levels within the postmenopausal range (as per local practice) in women aged <55years who have undergone hysterectomy.
•2. Histologically confirmed ER+ and PR+ breast cancers (defined as >10% positive staining cells)
•3. HER2/CEP17 ratio of <2 (as per the ASCO CAP guidelines)
•4. Tumour size >1cm as measured by ultrasound and/or mammogram
•5. Ability to understand all patient information and informed-consent documents, written informed consent to participate in the trial, and to avail tissue and blood samples for research

•1. Women currently on hormone therapies
•2. Locally advanced/inoperable and inflammatory breast cancer
•3. Clinical evidence of metastatic disease
•4. Patients treated with other preoperative systemic therapies
•5. Nut allergy (prometrium contains peanut oil)
•6. Prior history of uterine cancer, deep vein thrombosis or pulmonary embolism.

发起方

St Vincent's Hospital, Sydney