EUCTR2011-004822-85-AT进行中（未招募）1 期
A prospective, open, randomized, phase-II study of a therapeutic cancer vaccine (L-BLP25, Stimuvax®) in the pre-operative treatment of women with primary breast cancer - ABCSG-34
ABCSG (Austrian Breast & Colorectal Cancer Study Group)0 个研究点开始时间: 2011年11月30日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 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
- •Pre- and postmenopausal female patients with core-biopsied, early primary invasive breast cancer of any clinical and/or radiological tumor stage (except T4d, inflammatory breast cancer) scheduled to receive pre-operative therapy.
- •One core from the biopsy will be dedicated to analyses of a validated gene expression array
- •Patients must fulfill the following criteria:
- •-Postmenopausal AND E+++ or [E++ and ki67<14%] AND G 1,2,X AND scheduled for endocrine therapy as standard of care (34 A)
- •-Triple negative OR E- OR E+ OR [E++ and ki67>14%] OR G3 OR premenopausal status AND scheduled for anthracyclin-taxan-based chemotherapy as institutional standard of care (34 B)
- •*Note: for ki67 status determination any antibody can be used; scores for determination of E/PR receptor status according to institutional standard
- •No distant metastasis (M0) or secondary carcinoma as assessed clinically and radiologically (X-Ray or CT or MRI or PET) within 3 months prior randomization
- •Age = 18
- •WHO performance status 0 or 1
- •No prior chemotherapy, radiotherapy, or endocrine therapy for invasive breast cancer
- •Willingness to undergo Sln and/or ALND Procedure (Sentinel/Axillary Lymph node dissection) acc. to institutional standard
- •No medical and/or cardiologic contraindication to receive an anthracyclin- and taxan-containing chemotherapy or endocrine therapy regimen
- •Adequate Hematologic function (= 14 days prior to randomization)
- •Adequate Renal function (= 14 days of randomization)
- •Adequate Hepatic function (= 14 days of randomization)
- •Adequate cardiac function: Normal cardiac function must be confirmed by LVEF (Echocardiography or MUGA scan) for chemotherapy treatment only. The result must be above 50% or above the lower normal limit of the institution. In addition each of the following criteria must be met:
- •o NYHAo No uncontrolled angina, arrhythmia, hypertension
- •o No myocardial infarction over the last 6 months as confirmed by ECG
- •Negative pregnancy test (serum or urine) max. 7 days prior to randomization for pre-menopausal patients. In postmenopausal patients, no pregnancy tests must be performed at any time, requested that
- •a) FSH and estradiol are in postmenopausal range and/or
- •b) the patient is amenorrhoeic for > 12 months with uterus still in situ and/or
- •c) the patient is 61 years of age or older.In this situation, the investigator must document why the pregnancy test was not performed.
- •In all premenopausal patients adequate conception with non-hormonal methods (e.g. condoms, non-levonorgestrel-releasing intrauterine devices, diaphragms, vasectomized partner, or abstinence) is mandatory during study duration until at least 30 days after the last vaccination of L-BLP25.
- •Competent to comprehend, sign, and date an IEC/IRB-approved informed consent form and able to comply with the required treatments, visits and assessments
- •Informed consent signed prior to randomization and prior to any study specific procedure (study specific baseline blood sample)
- •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 400
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 400
排除标准
- •HER2 overexpression (+++)
- •Past or current history of other neoplasms in the last 5 years, except basal cell cancer of the skin, non-melanoma skin cancer and in situ cancer of the cervix
- •Any medical condition rendering the patient unfit for standard of care pre-operative therapy (chemotherapy or endocrine therapy in the respective SoC treatment group)
- •Concurrent or prior systemic antitumor therapy < 5 years
- •Patients scheduled for any chemotherapy other than EC->T or T->EC
- •Clinically significant cardiovascular disease (including unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) < 1 year before randomization
- •Known autoimmune disease (e.g. rheumatoid arthritis, systemic lupus erythematosus, ulcerative colitis, Crohn´s disease, multiple sclerosis, ankylosing spondylitis)
- •Severely compromised haematopoietic function
- •Known immunodeficiency disease (cellular immunodeficiency, hypogammaglobulinaemia, dysgamaglobulinaemia)
- •Known positive test(s) for human immunodeficiency virus (HIV) infection, hepatitis C virus, acute or chronic active hepatitis B infection
- •Active infection requiring systemic treatment or any uncontrolled infections < 14 days prior to randomization
- •Major surgery, or significant traumatic injury occurring within 4 weeks prior randomization
- •Use of i.v. or s.c. immune modulators (Viscum album etc.)
- •Pre-treatment with L-BLP25
- •Concurrent treatment with another approved or investigational anticancer treatment is not permitted, excluding therapy as permitted in the protocol
- •Concurrent participation in another clinical trial with the same endpoints is not permitted
- •Pregnancy or breastfeeding
- •Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or IMP/NIMP administration, or which, in the judgment of the investigator, would make the patient inappropriate for enrollement into this study
- •Known hypersensitivity against taxanes and/or epirubicin and/or cyclophosphamide or aromatase inhibitors in the respective SoC treatment group
- •Concurrent treatment with corticosteroids except as use for the prophylactic medication regimen, inhalational use, prevention or treatment of acute hypersensitivity reactions, treatment of nausea / vomiting or chronic treatment (initiated > 6 months prior to study entry) at low dose (< 20 mg methylprednisolone or equivalent)
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