RESPONDER Trial - Diagnosis of Pathological Complete Response by Vacuum-assisted Biopsy After Neoadjuvant Chemotherapy in Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 452
- 试验地点
- 1
- 主要终点
- false negative VAB results, reported as the false negative rate (= FNR)
研究概览
简要总结
The main purpose of the study is to evaluate the potential of a minimal invasive, vacuum-assisted biopsy (VAB) to reliably diagnose a pathological complete response (pCR) in the breast after neoadjuvant chemotherapy (NACT) in breast cancer patients.
The study is designed as a multicenter, confirmative, one-armed, intra-individually-controlled, open, diagnostic trial, in which we aim to confirm the applicability of preoperative VAB in patients after NACT. Furthermore, we aspire to quantify the rate of concordant pathological findings (pCR yes / no) in biopsy and surgical specimen.
详细描述
In clinical routine surgical treatment follows the pre-operative chemotherapy (NACT). However, recent studies have demonstrated that shrinking tumors need less surgical treatment indicating that patients with pCR could potentially be spared of surgery in the future. However, up to now, prediction of pCR after NACT is only moderately accurate. This prospective, monocenter diagnostic trial aims to explore if minimal invasive biopsies (MIB) might overcome this diagnostic challenge.
Ultrasound guided VAB will be performed on 600 breast cancer patients after NACT and directly prior to surgery.
There are only two trial visits that are specific to the trial. All other visits will be routine visits.
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The first trial visit will take place in order to provide the patient with detailed information on the study, its' aims, the VAB procedure, and its risks. The patient will be asked to sign a form of informed consent.
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At the second trial visit the performance of the VAB (=index test) will take place. This trial visit may vary by patient, tumor, and trial site characteristics and may either be:
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An ultrasound guided VAB or
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A stereotactically / mammographically guided VAB. All possible VAB procedures and settings (in outpatient clinic, or in operating room directly before the surgery) are equally accepted. We will allow every trial site to choose the adequate setting to the trial site´s and to their patients' needs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients with primary breast cancer after Neoadjuvant Chemotherapy (NACT) treatment which has been performed for at least 12 weeks and resulted in cPR or cCR (see below).
- •>/=18 years
- •any cT and cN stage, except cT4 stages
- •any routine breast cancer surgical intervention planned according to guidelines (breast conservation or mastectomy)
- •Residual intramammary target lesion or clip marker is visible in ultrasound and / or mammography
- •Diagnosis of imaging complete or partial response according to RECIST 1.1 by at least mammography or ultrasound, according to local routine)
- •Inclusion of only one breast per patient, in bilateral cancer one breast can be included
- •In case of multicentric disease: confirmation of the same tumorbiological subtype defined by immunohistology in at least 2 lesions.
- •Ability of subject to understand character and individual consequences of the clinical trial.
- •Written informed consent (must be available before enrolment in the trial).
排除标准
- •Palliative or recurrent breast cancer
- •in case of clip marker = target lesion: dislocation of marker (>5mm distance to the initial lesion border at the time of clip placement)
- •contraindication for VAB or associated procedures (e.g. local anesthesia)
- •Pregnancy and lactation
- •held in an institution by legal or official order
- •legally incapacitated.
研究组 & 干预措施
single-arm study
This project is designed as a one-armed diagnostic study. Every patient included in the study will undergo the same diagnostic test, the vacuum-assisted biopsy, after NACT and before surgery according to guidelines.
干预措施: Vacuum-Assisted Biopsy (Device)
结局指标
主要结局
false negative VAB results, reported as the false negative rate (= FNR)
时间窗: after breast surgery, up to 6 weeks after VAB
non-detected residual tumor by VAB (=index test) compared to breast surgery (=reference test): FNR = rate of patients with non-detected residual tumor by VAB compared to breast surgery Residual tumor is defined as a positive result; in surgical specimen as well as in VAB.
次要结局
- negative predictive value (NPV)(after breast surgery, up to 6 weeks after VAB)
- false positive rate (FPR)(after breast surgery, up to 6 weeks after VAB)
- positive predictive value (PPV)(after breast surgery, up to 6 weeks after VAB)
研究者
Jörg Heil
Prof. Dr. Joerg Heil
Heidelberg University