Randomised phase II window study of short term preoperative treatment with the PI3K inhibitor GDC0941 plus Anastrozole versus Anastrozole alone in patients with ER positive primary breast cancer

Brighton & Sussex University Hospitals NHS Trust (UK)0 个研究点目标入组 141 人开始时间: 2014年2月18日最近更新: 2019年12月10日

适应症

试验速览

•1. Histologically confirmed breast cancer involving a palpable tumour of any size, or a tumour with an ultrasound assessed diameter of = 1.0 cm
•2. Estrogen receptor (ER) positive tumours with =1% of tumour cells positive for ER on immunohistochemical staining or an immunhistochemistry score (Allred) of 3 or higher
•3. No prior systemic treatment regimens for the new primary breast cancer currently under investigation; prior treatment for previous breast cancer is allowed as long as it was completed at least 1 year prior to inclusion into this trial
•4. Postmenopausal, defined as 1) age = 55y and 1y or more of amenorrhea, OR 2) age < 55y and 1y or more of amenorrhea, with an estradiol assay <20 pg/mL, OR 3) age < 55y with prior hysterectomy but intact ovaries with an estradiol level <20 pg/mL,
•5. Status after bilateral oophorectomy (= 28 days prior to first study treatment)
•6. Adequate hematologic function (ANC = 1500 cells/µl + platelet count = 100000/µl)
•7. Serum creatinine concentration < 1.5 x ULN¿ AST, ALT, bilirubin level < 1.5 x ULN¿ Fasting plasma glucose level < 7.8 mmol/L
•8. ECOG performance status 0-2
•9. Written informed consent prior to admission to the study

•1. Male gender
•2. Inflammatory breast cancer
•3. HER2 positive tumours with 3+ intensity on IHC staining for HER2 or amplification of the HER2 gene on ISH
•4. Evidence of distant metastases
•5. Previous systemic or local treatment for the new primary breast cancer currently under investigation (including surgery, radiotherapy, cytotoxic and endocrine treatments); prior treatment for previous breast cancer is allowed as long as it was completed at least 1 year prior to inclusion into this trial
•6. Clinically significant pulmonary dysfunction
•7. Uncontrolled Type 1 or 2 diabetes mellitus (diabetic patients must have been on a stable regimen of oral antihyperglycemic therapy for at least 3 weeks duration and must have home monitoring levels without fasting blood glucose >8.9 mmol/L or hypoglycemia for one week prior to study entry)
•8. Serious intercurrent medical or psychiatric illness, including serious active infection
•9. Concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days prior to study entry
•10. Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator?s opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications

发起方