EUCTR2012-002525-29-FR进行中（未招募）不适用
A phase II trial evaluating the Activity of Abiraterone Acetate plus Prednisone in Patients with a Molecular Apocrine HER2-negative locally advanced or metastatic Breast Cancer. - AMA
ICANCER0 个研究点开始时间: 2013年4月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- 性别
- Female
入选标准
- •1)Women aged = 18 years,
- •2)Histologically confirmed locally advanced or metastatic breast cancer,
- •3)Triple negative breast cancer:
- •Estrogen receptor (ER)-negative and Progesteron receptor (PR)-negative, as defined by a < 10 % tumour stained cells by immunohistochemistry (IHC); HER2 negative status (i.e. IHC score 0 or 1+, or IHC score 2+ and FISH/SISH/CISH negative), confirmed centrally before inclusion with FFPE tissue from either primary or metastatic breast cancer site*,
- •* In case of discordant ER and/or PR status between the primary tumour and the metastatic site, the status of the metastatic site will be used to decide whether the patient would be eligible or not
- •4)Androgen receptor (AR)-positive, as defined centrally by a = 10% tumour stained cells by IHC (AR assessment by local pathologist before inclusion is not mandatory),
- •5)Patients could be chemotherapy naïve (provided they are not presenting with life-threatning metastasis) or have received any number of previous lines of chemotherapy (providing their life expectancy is = 3 months),
- •6)Pre and post menopausal patients are eligible. In the exceptional situation of a premenopausal patient, the addition of LHRH analog is recommended (androgens might act as an estrogen antagonist in premenopausal patients),
- •7)Measurable or non measurable disease according to RECIST v1.1 criteria,
- •8)PS (ECOG) = 2,
- •9)Normal haematological function: ANC = 1,500/mm3; platelets count = 100,000/mm3; haemoglobin > 10 g/dl,
- •10)Normal hepatic function: total bilirubin = 1.5 upper normal limit (UNL); ASAT and ALAT = 2.5 UNL (= 5 UNL in the presence of liver metastases),
- •11)Creatinine clearance (MDRD formula) = 50 mL/min OR creatinine = 1.5 times ULN,
- •12)Normal kalemia (serum potassium = 3.5mM), natremia and magnesaemia,
- •13)Systolic blood pressure (BP) < 160 mm Hg and diastolic BP < 95 mm Hg, as documented on inclusion day (Hypertension at baseline assessment allowed provided it is currently controlled under anti-hypertensive drugs),
- •14)Cardiac ejection fraction =50% measured by MUGA or ECHO done within 4 weeks before inclusion,
- •15)If receiving a bisphosphonate or denosumab, dose must have been stable for at least 2 doses before inclusion,
- •16)Patient agreeing to use effective contraception during and for = 6 months after completion of study treatment,
- •17)Patient able to comply with the protocol,
- •18)Patient must have signed a written informed consent form prior to any study specific procedures,
- •19)Patient must be affiliated to a Social Health Insurance.
- •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 31
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 31
排除标准
- •1)Male breast cancer,
- •2)HER2-positive status (positivity defined as IHC3+ and/or FISH amplification >2.2),
- •3)Other concurrent malignancies, except adequately treated cone-biopsied in situ carcinoma of the cervix or basal cell or squamous cell carcinoma of the skin; patients who have undergone potentially curative therapy for a prior malignancy are eligible provided there is no evidence of disease for = 5 years and patient is deemed to be at low risk for recurrence,
- •4)Active brain metastases or leptomeningeal disease; History of brain metastases allowed provided lesions are stable for at least 3 months as documented by head CT scan or MRI of the brain,
- •5)Non-malignant systemic disease, including active infection or concurrent serious illness that would make the patient a high medical risk,
- •6)Significant cardiovascular disease, including any of the following:
- •a)NYHA class III-IV congestive heart failure
- •b)Unstable angina pectoris or myocardial infarction within the past 6 months
- •c)Severe valvular heart disease
- •d)Ventricular arrhythmia requiring treatment,
- •7)Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not be included,
- •8)Persistent toxicities = grade 2 from any cause, except chemotherapy-induced alopecia and Grade 2 peripheral neuropathy,
- •9)Active or uncontrolled autoimmune disease requiring concurrent corticosteroid therapy,
- •10)Any gastrointestinal disorder interfering with absorption of the study drug,
- •11)Difficulties with swallowing study capsules,
- •12)Prior anticancer therapy, including radiotherapy, endocrine therapy, immunotherapy, chemotherapy (CT) within the last 3 weeks (2 weeks for oral or weekly CT ; 6 weeks for nitrosoureas and mitomycin C), or other investigational agents ; Concurrent palliative radiotherapy allowed,
- •13)Concurrent enrolment in another clinical trial in which investigational therapies are administered,
- •14)Pregnant women, women who are likely to become pregnant or are breast-feeding,
- •15)Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial,
- •16)Patients with history of non compliance to medical regimens or unwilling or unable to comply with the protocol,
- •17)Individual deprived of liberty or placed under the authority of a tutor.
研究者
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