EUCTR2010-019909-42-GB进行中（未招募）1 期
A double-blind, randomized, placebo-controlled, Phase I/II Study evaluating the safety, immunogenicity and clinical activity of neoadjuvant treatment with WT1-A10 + AS15 Antigen-Specific Cancer Immunotherapeutic in combination with standard therapy in patients with WT1-positive Stage II or III breast cancer. - WT1-AS15-BRS-001 (NEOADJ)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
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.The patient is at least 18 years of age at the time the informed consent to screening has been obtained.
- •2. The patient has proven T1 with lymph node involvement or T2-T4c, any N, M0 primary invasive breast cancer, histologically confirmed by core needle biopsy.
- •Isolated supraclavicular lymph node involvement is allowed.
- •3. The patient’s tumor shows WT1 antigen expression, detected by quantitative RT-PCR or any updated technique at the time of sample analysis.
- •4. The patient has one of the following histologically confirmed breast cancer subtypes:
- •Estrogen receptor (ER) and/or progesterone (PgR) positive tumor
- •HER2-overexpressing breast cancer
- •HER2-negative breast cancer.
- •5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at the time of study treatment allocation.
- •6. Baseline LVEF of equal or more than 50% as measured within six weeks prior to study treatment allocation by echocardiography or MUGA scan.
- •7. The patient shows normal organ function.
- •8. A female patient of childbearing potential may be enrolled in the study, if the patient:
- •has practiced adequate contraception for 30 days prior to study product administration, and
- •has a negative pregnancy test within one week prior to study treatment allocation, and
- •has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the study product administration series.
- •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 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •1. The patient has inflammatory breast cancer, which is defined as clinically significant erythema of the breast and/or documented dermal lymphatic invasion (not direct skin invasion by tumor or peau d'orange without erythema).
- •2. Diagnosis established by incisional biopsy.
- •3. Prior and concomitant neoadjuvant anti-breast-cancer treatments such as chemotherapy, immunotherapy / biological response modifiers, endocrine therapy, and radiotherapy, unless authorized specifically by the protocol.
- •4. The patient is known to be human immunodeficiency virus (HIV)-positive.
- •5. The patient has symptomatic autoimmune disease such as, but not limited to multiple sclerosis, lupus, and inflammatory bowel disease. Patients with vitiligo are not excluded.
- •6. The patient is known to have difficult-to-control hypertension, coronary artery disease, arrhythmia requiring treatment, clinically significant valvular disease, cardiomegaly on chest X-ray, ventricular hypertrophy on ECG or previous myocardial infarction or congestive heart failure.
- •7. The patient has a history of allergic reactions likely to be exacerbated by any component of the investigational product used in the study.
- •8. The patient has other concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk.
- •9. The patient has (or has had) previous or concomitant malignancies at other sites, except effectively treated malignancy that is considered by the investigator highly likely to have been cured.
- •10. The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent or to comply with the study procedures.
- •11. The patient has received any investigational or non-registered product (e.g., drug or vaccine) within 30 days preceding the first dose of study products or planned use during the study period.
- •12. The patient requires concomitant treatment with any immunosuppressive agents or with systemic corticosteroids prescribed for chronic treatment (more than seven consecutive days).
- •13. The patient has a significant disorder of coagulation or receives treatment with warfarin derivatives or heparin. Patients receiving individual doses of low molecular weight heparin outside of 24 hours prior to WT1-A10 + AS15 ASCI/placebo administration are eligible. Patients receiving prophylactic antiplatelet medications e.g. low-dose aspirin, and without a clinically-apparent bleeding tendency are eligible.
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