EUCTR2015-002323-25-SE进行中（未招募）1 期
A randomized phase III study comparing trastuzumab, pertuzumab plus docetaxel (TPD) followed by 3 cycles of chemotherapy to the current standard regimen as the treatments of early HER2-positive breast cancer - The BOLD-1 Study
Finnish Breast Cancer Group0 个研究点目标入组 1,366 人开始时间: 2017年1月26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
- 入组人数
- 1,366
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. Patient has provided a written informed consent prior to study-specific screening procedures, with the understanding that she has the right to withdraw from the study at any time, without prejudice.
- •2. Woman = 18 years of age.
- •3. Histologically confirmed invasive breast cancer.
- •4. HER2-positive breast cancer (preferably assessed with in situ hybridization; CISH, FISH or SISH; if not available, immunohistochemistry needs to be 3+)
- •5. A moderate or high risk of breast cancer recurrence with one of the following:
- •i) Pathological N0 with the longest invasive tumor diameter >10 mm
- •ii) Histologically confirmed regional node positive disease (pN+; nodal isolated tumor cells/cell clusters =0.2 mm in diameter (ITP) are not counted as a metastasis, whereas micrometastases >0.2 mm are considered metastases)
- •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 1000
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 366
排除标准
- •1. Presence of distant metastases.
- •2. Inflammatory breast cancer.
- •3. Clinically significant (i.e. active) cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmia not well controlled with medication) or myocardial infarction within the last 12 months.
- •4. Left ventricular ejection fraction less than 50% (or under the institutional normal reference range) assessed by echocardiography or isotope cardiography.
- •5. ER and HER-2 status (via in situ hybridization or immunohistochemistry) not determined.
- •6. The WHO performance status > 1.
- •7. Pregnant or lactating women.
- •8. Women of childbearing potential unless using a reliable and appropriate contraceptive method. Women must have been amenorrheic for at least 12 months prior to study entry to be considered postmenopausal and to have no childbearing potential. Women of childbearing potential (menstruating within 12 months of study entry), or with no hysterectomy and age < 55, must have a negative pregnancy test at baseline.
- •9. Randomization more than 12 weeks after the date of latest breast surgery.
- •10. Organ allografts with immunosuppressive therapy required.
- •11. Major surgery (except breast surgery) within 4 weeks prior to study treatment start, or lack of complete recovery from the effects of major surgery.
- •12. Participation in any investigational drug study within 4 weeks preceding treatment start.
- •13. Patients with a history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant precluding study participation.
- •14. Multifocal breast cancer when the largest cancer focus is not HER2-positive.
- •15. History of another malignancy or contralateral invasive breast cancer within the last five years except cured basal cell carcinoma of skin or carcinoma in situ of the uterine cervix (exception: patients with bilateral HER2-positive breast cancer are eligible).
- •16. One or more of the following:
- •Blood hemoglobin < 100 g/L, neutrophils < 1.5 x 10^9/L, platelet count < 120 x 10^^9/L
- •Serum/plasma creatinine > 1.5 x Upper Limit of Normal (ULN)
- •Serum/plasma bilirubin > ULN
- •Serum/plasma ALT and/or AST > 1.5 x ULN
- •Serum/plasma alkaline phosphatase > 2.5 x ULN
- •17. Serious uncontrolled infection or other serious uncontrolled concomitant disease.
- •18. Unwilling or unable to comply with the protocol for the duration of the study.
- •19. History of hypersensitivity to the investigational products or to drugs with similar chemical structures.
- •20. Pre-existing motor or sensory neurotoxicity of a severity = grade 2 by CTCAE version 4, unless related to mechanical etiology
研究者
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