Randomised, double-blind, multicentre phase III trial evaluating the safety and benefit of adding everolimus to adjuvant hormone therapy in women with high risk of relapse, ER+ and HER2- primary breast cancer who remain free of disease. - UNIRAD V5.0 14/02/2014

ICANCER0 个研究点目标入组 1,984 人开始时间: 2014年10月3日最近更新: 2018年2月12日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 1,984

研究概览入排标准研究者记录与标识符相似试验

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. Female = 18 years of age
•2. Histologically proven invasive unilateral or bilateral breast cancer (regardless of the morphological subtype)
•3. Any T, M0 (according to the American Joint Committee on Cancer classification)
•4. At least 4 positive lymph nodes if the patient had primary surgery, or at least 1 positive lymph node if surgery was conducted after neo-adjuvant chemotherapy or hormone therapy of at least 3 months duration
•5. ER+ and HER2 negative : Hormone receptor positive is defined as any staining on the primary tumor, HER2 negativity is defined as IHC 0-1+, or [IHC 2+ and FISH or CISH non-amplified]
•6. Primary tumor completely resected (deep margins and overlying skin involvement allowed if fully resected)
•7. Patients who have received at least 1 year but not more than 4 years of adjuvant hormone therapy. Hormone therapy could be either tamoxifen, letrozole, anastrozole or
•exemestane.
•8. No clinically or radiologically detectable metastases at time of inclusion.
•9. WHO Performance status (ECOG) of 0 or 1.
•10. Adequate hematological function (neutrophil count ? 2x109/l, platelet count ? 100x 109/l)
•11. Adequate hepatic function: AST and ALT = 2.5 ULN, alkaline phosphatases = 2.5 ULN, total bilirubin = 2 ULN.
•12. Adequate renal function: serum creatinine = 1.5 ULN.
•13. Signed written informed consent.
•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 250
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 250

排除标准

•1. Any local, or regional recurrence or metastatic disease.
•2. Any clinical or radiological suspicion of malignant or pre-malignant disease in the contralateral breast.
•3. Previous cancer (excepted basal cell carcinoma of the skin or in situ carcinoma of the cervix) in the preceding 5 years, including invasive contralateral breast cancer.
•4. Patient already included in another ongoing therapeutic trial involving an unlicensed drug for which follow-up is required.
•5. Patient who is pregnant or breast-feeding. Adequate birth control measures should be taken during the study treatment phase.
•6. Patient with significantly impaired lung function (e.g. Chronic Obstructive Pulmonary Disease, respiratory insufficiency, Interstitial Lung Disease)
•7. Positive serology for HIV infection or hepatitis C.
•8. Chronic carrier of HBV (positive Antigen HbsAg positive HbS in the blood)
•9. Patient with chronic infection
•10. Uncontrolled diabetes defined as glycated haemoglobinemia , HbA1c>7%
•11. Uncontrolled hypercholesterolemia (cholesterol >300 mg/dl under adequate therapy).
•12. Known hypersensitivity to the active substance, to other rapamycin derivatives or to any of the excipients.
•13. Patient with other concurrent severe and/or uncontrolled medical disease or infection which could compromise participation in the study (e.g. patient who regularly require systemic steroids to control co-morbid disease).
•14. Patient with any psychological, familial, social or geographical condition which could potentially hamper compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
•15. Patients with pN1mi as sole nodal involvement

研究者

发起方

ICANCER

相似试验

进行中（未招募）

1 期

EUCTR2008-006831-10-FIBoehringer Ingelheim1,300

进行中（未招募）

1 期

Multicenter, randomised, double-blind Phase III trial to investigate the efficacy and safety of BIBF 1120 in combination with carboplatin and paclitaxel compared to placebo plus carboplatin and paclitaxel in patients with advanced ovarian cancer - BIBF 1120 or placebo in combination with standard chemotherapy in advanced ovarian cancerAdvanced ovarian cancer, fallopian tube cancer or primary peritoneal cancerMedDRA version: 17.1Level: LLTClassification code 10026469Term: Malignant neoplasm of specified parts of peritoneumSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 17.1Level: LLTClassification code 10026340Term: Malignant neoplasm of peritoneum, unspecifiedSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 17.1Level: PTClassification code 10016180Term: Fallopian tube cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 17.1Level: PTClassification code 10033128Term: Ovarian cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

EUCTR2008-006831-10-BESCS Boehringer Ingelheim Comm.V1,300

进行中（未招募）

1 期

EUCTR2008-006831-10-GRBoehringer Ingelheim Hellas1,300

进行中（未招募）

1 期

EUCTR2008-006831-10-ITBOEHRINGER ING.1,400

进行中（未招募）

1 期

EUCTR2008-006831-10-FRBoehringer Ingelheim France1,300