NCT04118192进行中（未招募）不适用
Can Patients With Residual Cancer After Chemotherapy for Early Breast Cancer be Identified With Multiple Ultrasound-guided Biopsies?
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 72
- 试验地点
- 24
- 主要终点
- Observed number of patients with false negative biopsies
研究概览
简要总结
A prospective non-randomised multi-centre feasibility study to assess if patients with residual cancer following dual-targeted neoadjuvant chemotherapy treatment for HER2-positive, ER-negative early breast cancer can be identified by multiple ultrasound (US)-guided tumour bed core biopsies
详细描述
The NOSTRA-Feasibility study is designed to determine if it is safe to omit surgery after the planned neoadjuvant chemotherapy plus dual-targeted anti-HER2 treatment. The study is needed to determine whether patients with residual cancer can be identified by histological examination of multiple ultrasound-guided tumour bed core biopsies following dual-targeted neoadjuvant treatment for HER2-positive, ER-negative early primary breast cancer and whether there is concordance between local pathology reporting and central pathology reporting by the trials expert pathologists.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patient with histological diagnosis of operable HER2-positive, ER-negative, early stage invasive breast cancer
- •Tumour size ≥ 1cm and visible on US (T1c to T4d)
- •Patient fit and willing to receive, or is already receiving and has received no more than five cycles of a NOSTRA-Feasibility Study approved treatment regimen, in the opinion of the responsible clinician
- •Eastern Co-operative Group (ECOG) performance status of 0 or 1
- •Women of child-bearing potential, prepared to adopt highly effective contraceptive measures if sexually active for at least 6 months after completion of study medication
- •Female, 18 years or older
- •Able to provide informed consent for the study
- •Availability of embedded paraffin tumour blocks from pre-chemotherapy biopsy
- •The radiology team are able and willing to perform the tumour bed core biopsies
排除标准
- •Previous ipsilateral invasive breast cancer or Ductal Carcinoma in Situ (DCIS)
- •Unequivocal evidence of distant metastatic disease at registration
- •Multi-focal disease at diagnosis
- •Active malignancy
- •Previous chemotherapy
- •Prior extensive radiotherapy (as judged by the Investigator) to bone marrow
- •Risk factors precluding the safe administration of the intended cytotoxic chemotherapy regimen
- •Patient unsuitable for the planned dual-targeted anti-HER2 treatment in opinion of the Investigator
- •Prior diagnosis of cardiac failure
- •Uncontrolled hypertension, coronary heart disease or other significant cardiac abnormality
- •Bleeding diathesis
- •Any evidence of other disease which in the opinion of the Investigator places the patient at high risk of treatment related complications
- •Pregnant (female patients of child bearing potential must have a urine or blood Human Chorionic Gonadotropin test performed to rule out pregnancy prior to study entry)
- •Patient lactating
- •Patients who have received live vaccine within 4 weeks of the date of study entry
- •Any concomitant medical or psychiatric problems which in the opinion of the Investigator would prevent completion of treatment or follow-up
- •Patient unfit and/or unwilling to undergo surgery
- •Patient unwilling or unable to comply with scheduled visits, treatment plan and study procedures
- •Patient has started protocol non-compliant neo-adjuvant chemotherapy
- •Patient has started approved neoadjuvant chemotherapy but insufficient data is available to complete relevant CRFs
- •Patient has already received more than five cycles of approved neoadjuvant chemotherapy
- •Additional Inclusion Criteria for ctDNA Sub-Study
- •Patient has not yet started neoadjuvant treatment
- •Patient is willing and able to give blood samples as per ctDNA Sub-Study Guidelines
结局指标
主要结局
Observed number of patients with false negative biopsies
时间窗: 12 months post last patient recruited
The observed number of patients with false negative biopsies (i.e. no tumour in the biopsy but tumour in the surgical specimen) as a proportion of all those assessed by Local Histopathology Review.
次要结局
- Concordance between Local and Central Histopathology Review of core biopsies(12 months post last patient recruited)
- Compliance with treatment(12 months post last patient recruited)
- Time to local recurrence(Number of days from registration to local recurrence (if within trial duration, approximately 1.5 years))
- Time to distant recurrence(Number of days from registration to distant recurrence (if within trial duration, approximately 1.5 years))
- Overall survival(Whole days from registration to death from any cause (if within trial duration, approximately 1.5 years))
- Re-evaluation of the primary outcome using the Central Pathological Review determination of RCB to define false negative biopsies as RCB-0 or 1 (i.e. no tumour or minimal residual disease) in the core biopsies but RCB-2 or 3 in the surgical specimen(Post-last patient last surgery (within approximately 1.5 years of start of trial))
- Ability of the axillary lymph node assessments post-neoadjuvant treatment to identify definitive axillary lymph node involvement determined by surgery histopathology(Post-last patient last surgery (within approximately 1.5 years of start of trial))
研究者
研究点 (24)
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