ACTRN12618001766202尚未招募不适用
Tracking Residual Disease Using Circulating Tumour DNA In High-Risk Early Breast Cancer
Peter MacCallum Cancer Centre0 个研究点目标入组 100 人开始时间: 2018年10月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Diagnosis
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Inclusion criteria for Pre-screening:
- •1.Provision of informed consent prior to any study specific procedures (pre-screening PICF)
- •2.Female or male patients >=18 years of age
- •3.Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast that is one of the two following phenotypes:
- •Triple negative breast cancer defined as:
- •Estrogen Receptor (ER) and Progesterone Receptor (PgR) negative defined as immunohistochemistry (IHC) nuclear staining <1%
- •HER2 negative (not eligible for anti-HER2 therapy) defined as:
- •–IHC 0, 1+ without ISH OR
- •–IHC 2+ and ISH non-amplified with ratio less than 2.0 and if reported, average HER2 copy number < 4 signals/cells OR
- •–ISH non-amplified with ratio less than 2.0 and if reported, average HER2 copy number < 4 signals/cells (without IHC)
- •ER and/or PgR positive, HER2 negative breast cancer defined as:
- •ER and/or PgR positive defined as IHC nuclear staining =1%.
- •HER2 negative (not eligible for anti-HER2 therapy) defined as for TNBC above.
- •4.Patients have AJCC 8th edition Clinical Prognostic Stage 3 Grade 2 or 3 disease as detailed below:
- •HistologyGradeTN
- •Triple negative breast cancerGrade 2-3T3-4 Any N or T2-4N1 or Any T N2-3
- •Hormone positive (ER+PR+)Grade 2T4 Any N or Any T N3
- •Grade 3T4 Any N or T3-4N1 or Any T N2-3
- •Hormone positive (ER+PR-) or (ER-PR+)Grade 2T4 Any N or T3-4N1 or Any T N2-3
- •Grade 3T3-4 Any N or T2-4 N1 or Any T N2-3
- •5.Be willing to provide tissue from core biopsy or surgical resection sample for somatic mutation(s) testing. Patients for whom fresh samples cannot be provided may submit an archived specimen.
- •6.Patients with multifocal or multicentric invasive disease are eligible as long as all the lesions for which HER2 characterization is available are HER2 negative.
- •7.Patients with synchronous bilateral invasive disease are eligible as long as all the lesions assessed for HER2 on both sides are negative.
- •In both the above cases the lesion considered at highest risk for recurrence based on the investigator’s discretion will be used for eligibility determination.
- •8.ECOG performance status 0-2
- •INCLUSION CRITERIA FOR MAIN STUDY
- •1.Provision of informed consent prior to any study specific procedures (main study PICF)
- •2.Patient has somatic mutation(s) in tissue for assessment of minimal residual disease.
- •3.Patient has received NAC or AC with curative intent. Please note patient must have received at least one cycle of chemotherapy to be eligible.
- •4.Patient is willing and able to comply with the protocol procedures for the duration of the study including undergoing blood collection, scheduled visits, examinations and completion of PROs
排除标准
- •EXCLUSION CRITERIA FOR PRE-SCREENING
- •1.Evidence of metastatic breast cancer
- •2.HER2 positive disease
- •3.Grade 1 primary disease
- •4.Patients with a second primary malignancy. EXCEPTIONS are:
- •Adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, Ductal Carcinoma in situ (DCIS) of the breast, stage 1 grade 1 endometrial carcinoma.
- •Other solid tumours and lymphomas (without bone marrow involvement) diagnosed >= 5 years prior to registration and treated with no evidence of disease recurrence and for whom no more than one line of chemotherapy was applied.
- •5.Patients considered at high medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection.
- •Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, extensive bilateral lung disease on High Resolution Computed Tomography scan or any psychiatric disorder that prohibits obtaining informed consent.
- •6.Patients with known active Hepatitis B or C or HIV
- •7.Patients who are/will be enrolled in another clinical trial evaluating other drug intervention(s) that will conflict with or interrupt the assessments of this study.
- •EXCLUSION CRITERIA FOR MAIN STUDY
- •1.Patient has developed a secondary primary malignancy or metastatic disease since signing the pre-screening consent
- •2.HER2 positive disease on the surgical specimen.
- •3.Grade 1 disease on the surgical specimen.
研究者
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