NL-OMON54716招募中3 期
Management of low-risk ductal carcinoma in situ (low-risk DCIS): a non-randomized, multicenter, non-inferiority trial; standard therapy versus active surveillance. - LORD LOw Risk Ductal Carcinoma In Situ
Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 2,500 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 2,500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 65 至 99（—）
入选标准
- •- Written informed consent according to ICH/GCP, and national/local regulations
- •- Women >= 45 years old, any menopausal status
- •- Unilateral DCIS of any size
- •- American Society of Anesthesiologists (ASA) score 1 -2 and 3, only if able
- •to undergo surgery and yearly mammography (see Appendix E)
- •- Lesions of type 'calcifications only', detected by population-based or
- •opportunistic screening mammography
- •- Within twelve weeks of detection at least six 12 G biopsies (or the
- •equivalent of six 12 G needles) need to be taken from the area of the
- •calcification. This implies at least 7 cc volume irrespective of supplier, or
- •at least three 8G, four 9G, five 10G or five 11G biopsy needles need to be
- •taken to meet LORD*s eligibility criteria. Whatever needle size is applied, it
- •is essential to confirm that the biopsies contain representative calcifications
- •via biopsy radiography, microscopy, or both.
- •- In case of an extended lesion (> 5 cm): biopsies were taken from the center
- •and the periphery of the lesion, or from two peripheral parts of the lesion
- •- In case of multiple lesions with calcifications biopsies have been taken from
- •two, but not more, groups of calcifications
- •- Estrogen receptor >=80% positive and HER2 negative: 0 or 1+ or 2+ with
- •negative ISH), analysed centrally by pathology at NKI-AVL
- •- Marker placement at biopsy site (s) in the breast . Note: if patient prefers
- •surgery, marker placement is not mandatory.
- •- FFPE tissue blocks from the biopsy and, if applicable, from the resection
- •specimen, available for translational research purposes. If no FFPE tissue
- •blocks can be submitted, 10 unstained slides of 4-5 µm thickness from the
- •lesion(s) are acceptable
- •- Good correlation between pathological and radiological findings i.e. both
- •findings confirm low-risk DCIS and no suspicion high- grade DCIS or invasive
- •breast cancer
- •- The interval between histologic diagnosis of low-risk DCIS on biopsy and
- •randomization is <= 12 weeks
排除标准
- •-Estrogen receptor negative: <80% or HER2 positive: 3+, or 2+ with positive ISH
- •- Presence of either mass, increased focal density or architectural distortion
- •around the calcifications on mammography (suspicious for invasive disease)
- •- Presence of Paget*s disease, invasive breast cancer, or pleomorphic LCIS;
- •Lobular neoplasia, referring to atypical lobular hyperplasia (ALH) and/or
- •classic Lobular Carcinoma In Situ according to the WHO Classification of
- •Tumours of the Breast, is no reason to exclude
- •- Symptomatic DCIS e.g. DCIS detected by palpation or bloody nipple discharge
- •- Synchronous invasive carcinoma in the contralateral breast
- •- Prior history of invasive breast cancer or DCIS, prior surgery because of
- •benign breast lesion (s) is allowed
- •- Prior history of other cancer except carcinoma in situ of the cervix or basal
- •carcinoma of the skin
- •- Serious disease that precludes definitive surgical treatment (e.g
- •cardiovascular/ pulmonary/ renal disease)
- •- Individual with a family member with a known gene mutation associated with
- •increased risk of breast cancer, unless study participant is a proven
- •non-carrier of mutation
- •- Any psychological, familial, sociological or geographical condition
- •potentially hampering compliance with the study protocol and follow-up
- •schedule; those conditions should be discussed with the patient before
- •registration in the trial
- •- Pregnancy or breast-feeding. Contraceptive measures during the trial are
- •mandatory for those patients that will participate in standard treatment arm
- •and adequate counselling should be provided by the treating physician. The
- •duration of contraception will be specified by the treating physician according
- •to patient and treatment characteristics, standard clinical practice and
- •national regulations
研究者
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