EUCTR2007-007257-31-PT进行中（未招募）不适用
Open-label, single arm, phase II study for evaluation of complete response rate at surgery after NEOadjuvant treatment with SUnitinib and docetaxel in patients with newly diagnosed large operable or locally advanced breast cancer - NEOS
IPOLFG0 个研究点目标入组 30 人开始时间: 2008年1月28日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
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. Histologically or cytologically proven newly diagnosed untreated invasive breast cancer
- •(independent of ER, PgR and Her2 status), existence of a tumour greater than 3 cm in diameter
- •by caliper measurement and/or N2-3 disease with a palpable breast mass.
- •2. Indication for neoadjuvant chemotherapy as judged by the institutional multidisciplinary
- •conference (large operable tumour aiming at breast conservation, locally advanced or
- •inflammatory disease).
- •3. Multifocal and multicentric breast tumours are allowed as long as only two tumour foci are
- •identified, since two sequential tumour samples are to be collected from each tumour focus.
- •4. Consent to perform two core biopsies: one immediately before sunitinib administration and
- •another after the two weeks of the first course of sunitinib treatment.
- •5. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and
- •other study procedures.
- •6. Adequate organ function
- •7. Female, 18 years of age or older.
- •8. ECOG performance status 0, 1 or 2.
- •10. Signed and dated informed consent document indicating that the patient (or legally
- •acceptable representative) has been informed of all the pertinent aspects of the trial prior to
- •11. Consent to undergo breast cancer surgery at day 113.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Diagnosis of any second malignancy within the last 3 years, except for adequately treated
- •basal cell carcinoma or squamous cell skin cancer or in situ carcinoma of the cervix uteri.
- •2. Prior treatment for cancer, including systemic chemo or endocrine therapy, surgery or
- •radiation, tyrosine kinase inhibitors or antiangiogenic therapy.
- •3. Metastatic breast cancer.
- •4. Patients for whom docetaxel is contraindicated according to the local prescribing
- •information.
- •5. History of severe hypersensitivity reactions to docetaxel or to other drugs formulated with
- •polysorbate 80.
- •6. Major surgery, radiation therapy, or systemic therapy within 3 weeks of start of study
- •7. Prior radiation therapy to >25% of the bone marrow (whole pelvis is 25%).
- •8. Current treatment on another clinical trial.
- •9. Any of the following within the 12 months prior to starting study treatment: myocardial
- •infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart
- •failure, cerebrovascular accident including transient ischemic attack, or pulmonary embolus.
- •10. Ongoing cardiac dysrhythmias of grade =2, atrial fibrillation of any grade, or QTc interval
- •>470 msec.
- •11. Hypertension that cannot be controlled by medications (>150/100 mmHg) despite optimal
- •medical therapy).
- •12. Current treatment with therapeutic doses of warfarin (low dose warfarin up to 2 mg PO daily
- •for deep vein thrombosis prophylaxis or i.v. catheter patency is allowed).
- •13. Known human immunodeficiency virus infection.
- •14. Pregnancy or breastfeeding.
- •15. Female of child-bearing potential that is unwilling or unable to use adequate contraception
- •to prevent pregnancy during the program, (all female patients with reproductive potential must
- •have a negative pregnancy test (serum or urine) prior to study entry).
- •16. Other severe acute, chronic medical, psychiatric condition, or laboratory abnormality that
- •would impart, in the judgment of the investigator, excess risk associated with study participation
- •or study drug administration, or which, in the judgment of the investigator, would make the
- •patient inappropriate for entry into this study.
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