EUCTR2010-024216-34-AT进行中（未招募）1 期
eoadjuvant Endocrine Treatment +/- Bevacizumab in postmenopausal Patients with Operable Primary, HER2-neu negative Breast Cancer (including Lobular Cancer) (I) not suitable for Chemotherapy or (II) unlikely to respond to Chemotherapy
ABCSG (Austrian Breast & Colorectal Cancer Study Group)0 个研究点目标入组 0 人开始时间: 2011年2月2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
- •- Female Patients with histologically diagnosed hormone receptor positive (ER and/or PR positive ), HER2/neu negative (IHC < 2+ or FISH negative) operable breast cancer
- •1. Any condition excluding a patient from chemotherapy but not from endocrine treatment in combination with bevacizumab and therefore allowing patients to enter the study are:
- •(i) biological age
- •(ii) ECOG Performance status =2
- •(iii) normal or reduced hematopoietic reserve, but leukocytes >1,500/µl, platelets >1000,000/ µl and Hb =8 g/dl
- •(iv) Normal or reduced renal function but no necessity for dialysis
- •2. Stage I, II or Stage III (T2-T4a-c, N0-3, M0)
- •3. Postmenopausal status, defined as:
- •a) the patient is amenorrhoeic for > 12 months or
- •b) FSH and estradiol are in postmenopausal range or
- •c) the patient is 61 years of age or older.
- •4. No prior chemotherapy, radiotherapy, or endocrine therapy for invasive or non-invasive breast cancer.
- •5. Normal cardiac function must be confirmed by LVEF (MUGA scan or Echocardiography) within 4 weeks prior to randomization. The result must be above 50% .
- •6. Signed and dated informed consent
- •7. Willingness and ability to comply with treatment and all study related procedures
- •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
- •Concomitant conditions
- •1. Metastatic disease
- •2. Inflammatory carcinoma (T4d)
- •3. HER2neu positive breast cancer
- •4. Prior treatment for breast cancer
- •5. Active viral, bacterial or fungal infection
- •6. History of solid organ transplantation
- •7. CNS involvement by Breast Cancer or any evidence of spinal cord compression. Brain CT/MRI is only mandatory in case of clinical suspicion of CNS involvement by Breast Cancer
- •8. Prior malignancy (except adequately treated basal cell carcinoma of the skin, in situ cervical cancer, or any other cancer for which the patient has been in remission for at least 5 years)
- •9. Known hypersensitivity to study drug or its ingredients (i.e., hypersensitivity to Polysorbate 20, CHO cell products, or recombinant human antibodies)
- •10. Severe chronic obstructive pulmonary disease with hypoxemia
- •11. thrombosis unless resolved and under adequate control by anticoagulation (see 24)
- •12. Uncontrolled hypertension (>150mmHg and/or a diastolic >100 mmHg) or clinically significant (i.e. active) cardiovascular disease (CVA/stroke within <6 months prior to randomization) myocardial infarction within < 6 months prior to randomization, unstable angina pectoris, congestive heart failure (= NYHA Grade II), or serious cardiac arrhythmia requiring ongoing medication, NYHA = Grade II
- •13. Clinically significant, active peripheral vascular disease, serious non healing wound/ulcer, bone fracture, bleeding diathesis (history or evidence of inherited bleeding diathesis) and/or coagulopathy
- •14. History of active ulcer (within 1 year prior to randomization), abdominal fistula, gastrointestinal perforation, or intraabdominal abscess or concurrent therapy for treatment/prevention of ulcer
- •15. Evidence of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug, or patient at high risk from treatment complications
- •16. Any co-existing medical or psychological condition that would compromise ability to give informed consent
- •17. Uncontrolled diabetes mellitus
- •Current treatment
- •18. Seizures requiring permanent anticonvulsant therapy
- •19. chronic daily treatment with corticosteroids (dose =10 mg/d methylprednisolone or equivalent) with the exception of inhaled steroids
- •20. chronic daily treatment with acetylsalicylic acid (aspirin or analogs >325 mg/day) or clopidrogel (>75 mg/day)
- •21. Major surgery, open biopsy or trauma within 28 days before randomization (fine-needle biopsies of breast tissue or lymph node are not considered major surgery), or the need for major surgery during the course of study treatment (adequate time delay of 6 weeks between last cycle of bevacizumab and surgery is considered in the design of the trial)
- •22. Current or recent (within the 30 days prior to randomization) treatment with another investigational drug or participation in another investigational therapeutic study
- •Laboratory (determined within 7 days prior to day 1 cycle 1)
- •23. Inadequate liver function, defined as:
- •- serum (total) bilirubin >1.5 x the upper limit of normal (ULN) for the institution
- •- AST/SGOT or ALT/SGPT >2,5 x ULN
- •- ALP >2.5 x ULN at baseline
- •24. Patients not receiving anticoagulant medication who have an International Normalized Ratio (INR) >1.5 or an activated partial thromboplastin time (aPTT) >1.5 x ULN within 7 days prior to first study treatment
- •25. Inadequate renal function (Proteinuria), d
研究者
相似试验
已完成
不适用
Immediate optimal endocrine adjuvant therapy versus standard chemotherapy followed by the same endocrine therapy in pre- or peri-menopausal patients with early hormone receptor-positive breast cancer - the Promise studyCancerBreast cancerISRCTN23561723Breast Cancer Study Group (BOOG) (The Netherlands)25
已完成
3 期
Tamoxifen Citrate or Letrozole With or Without Bevacizumab in Treating Women With Stage IIIB or Stage IV Breast CancerInvasive Breast CarcinomaRecurrent Breast CarcinomaStage III Breast Cancer AJCC v6Stage IV Breast Cancer AJCC v6 and v7NCT00601900National Cancer Institute (NCI)394
尚未招募
2 期
Bevacizumab in combination with metronomic dose temozolomide in patients with relapsed high grade gliomasbrain tumorRecurrent high grade glial tumors10029211NL-OMON30453Academisch Medisch Centrum30
进行中（未招募）
不适用
Bevacizumab in combination with metronomic dose temozolomide in patients with relapsed high grade gliomas - BEvacizumab + TEmozolomide in Relapsed gliomaPatients with a recurrent high grade glioma (after primary treatment)MedDRA version: 9.1Level: LLTClassification code 10018338Term: GliomaEUCTR2007-000488-38-NLAcademic Medical Center
尚未招募
2 期
Ribociclib in combination with endocrine therapy in patients with “estrogen receptor-positive and HER2-negative” breast cancer with high risk of recurrence2023-508827-10-00Solti Group1,100