EUCTR2010-019965-27-BE进行中（未招募）1 期
Fulvestrant with or without AZD6244, a mitogen-activated protein kinase kinase (MEK) 1/2 inhibitor, in advanced stage breast cancer progressing after aromatase inhibitor: a randomized placebo-controlled double-blind phase II trial. - Fulvestrant with or without AZD6244 in ABC
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
- 89
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
- •- Patient must give written informed consent before any trial-specific examination and randomization.
- •- Histologically/cytologically confirmed diagnosis of breast cancer.
- •- Advanced stage breast cancer (HER2 positive is allowed), not amenable to curative therapy.
- •- All available biopsies tested are estrogen receptor and/or progesterone receptor positive: =10 % tumor cells positive by immunohistochemistry or = 10 fmol/mg cytosol protein by ligand binding assay.
- •- Patients with bilateral breast cancer are eligible if tumors endocrine sensitivity has been proven on both sides.
- •- Relapse or progression after AI used as adjuvant therapy or for advanced stage disease. Previous treatment with tamoxifen is allowed.
- •- = 1 line of chemotherapy for advanced stage breast cancer.
- •- Measurable disease (according to RECIST criteria v1.1 [80]) or other lesions assessable by radiological exams, i.e. bone-only disease or small but unequivocal liver or lung metstases [96].
- •- Postmenopausal women (FSH, LH, and estradiol must be measured in case of doubt to confirm postmenopausal status)
- •- WHO performance status of 0, 1, or 2 (see Appendix 3)
- •- Patient is able to swallow AZD6244/placebo capsules
- •- Patient has capability to understand information given by the investigator on the trial.
- •- Patient adherence and geographic proximity allow proper staging, treatment, and follow-up.
- •- Adequate hematological values: hemoglobin level > 90 g/L, platelets = 100 x 109/L, and neutrophils = 1.5 x 109/L.
- •- Adequate coagulation tests: INR (International Normalized Ratio) <1.6 and PTT (partial thromboplastin time) in the normal range.
- •- Adequate renal function (creatinine clearance > 30mL/min according to Cockcroft-Gault Formula (see Appendix 2)).
- •- Adequate hepatic function: ALT = 2.5 x ULN (or = 5 x ULN in patients with liver metastases), bilirubin = 1.5 x ULN.
- •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 18
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •- Previous treatment with fulvestrant, AZD6244, MEK inhibitors, RAF inhibitors, or endocrine therapies other than AIs (anastrazole, letrozole, exemestane) and tamoxifen.
- •- More than 1 line of AI (steroidal and non steroidal AIs are considered two different lines).
- •- 2 or more lines of chemotherapy for advanced disease
- •- Concomittant cancer therapy or other experimental drugs.
- •- Treatment with other experimental drugs or participation in a clinical trial within 30 days prior to trial entry.
- •- Contraindication for intramuscular injections
- •- Known central nervous system metastasis (patients with brain metastasis treated with radiotherapy and without any sign of brain progression after > 3 months since the end of the radiotherapy may be considered eligible after trial chair approval)
- •- Bleeding diathesis.
- •- Full-dose anticoagulation during the trial treatment (see also 6.1.16). (Patients receiving full-dose anti-coagulant therapy with low molecular weight heparin or acenocoumarol, phenprocoumone, or analogues are ineligible. Patients receiving prophylactic doses of anticoagulation or antiplatelet drugs are eligible, but the risk of bleeding following intramuscular injection of fulvestrant is higher and the risk/benefit ratio has to be assessed by the investigator.
- •- Current or previous malignancy other than breast cancer within the last 5 years (except: in situ carcinoma of the cervix and basal carcinoma of the skin treated curatively).
- •- Any serious underlying medical condition (at the judgment of the investigator) which could impair the ability of the patient to participate in the trial (e.g. active autoimmune disease, uncontrolled diabetes).
- •- Refractory nausea and vomiting, chronic GI disease (e.g. inflammatory bowel disease) or significant bowel resection that preclude adequate absorption.
- •- Psychiatric disorder precluding understanding of information on trial related topics, giving informed consent, or interfering with adherence for oral drug intake.
- •- Uncontrolled hypertension (systolic >150 mmHg and/or diastolic >100 mmHg, measured repeatedly at more than two visits despite adequate treatment with at least two different antihypertensive drugs).
- •- Clinically significant (i.e. active) cardiovascular disease: CVA/stroke or myocardial infarction within 6 months prior to registration, unstable angina, congestive heart failure [New York Heart Association (NYHA) Class = III (see Appendix 4)], serious cardiac arrhythmia or AV-block >1, requiring medication during the trial and which might interfere with regularity of the trial treatment, or not controlled by medication.
- •- In the presence of symptoms suggestive of cardiac impairment (i.e. dyspnea, orthopnea, paroxistic nocturne dyspnea and edema), baseline LVEF must be measured. In this case, patients with baseline LVEF < 50% are excluded.
- •- Known hypersensitivity to trial drug(s) or hypersensitivity to any other component of the trial drugs.
研究者
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