VISION: Defining Biomarkers of Chemotherapy & Immunotherapy Response and Validation of the Breast Cancer Therapeutic Response Predictive Algorithm for Early Triple Negative Breast Cancers
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Validate accuracy of the Breast cancer therapeutic response predictive algorithm for predicting pathological complete response (pCR) in the early TNBC population treated with neoadjuvant chemotherapy.
研究概览
简要总结
Background: Despite improvements in the treatment of Triple Negative Breast Cancer (TNBC), the cancer returns in half of the women and shockingly 40% are dead within 5 years of their initial cancer diagnosis. There is an urgent need to identify reliable biomarkers of response for chemotherapy and immunotherapy.
Study Aims: To update Concr's existing predictive algorithms specifically for use in women newly diagnosed with TNBC.
The plan is develop technology which will predict which drug the cancer will respond best to, treatment A vs. treatment B AND how the individual's prognosis could change if treatment A is chosen overtreatment B.
Study Design: The VISION study is a clinical study looking back in time (retrospective study), specifically focusing on women who were previously diagnosed with early Triple Negative breast cancer and received chemotherapy followed by curative breast surgery. The plan is to collect historical clinical data and previously collected cancer biopsy samples from up to 200 women in order to update Concr's existing treatment prediction algorithms. Hence there are no extra research biopsies needed in order to participate in the Study.
Study Sites: UK and Australia
Study Funding: This study is funded by the a Techbio company called Concr with support from Innovate UK (UK Government funding).
详细描述
VISION is a commercially sponsored clinical trial designed to be a retrospective, observational non-CTIMP research study which will collect archival tumour samples from participants previously treated with chemotherapy +/- immunotherapy for early Triple Negative Breast Cancer (TNBC).
Current Study design:
VISION currently has 2 retrospective patient cohorts:
- Arm A: Patients treated with neoadjuvant chemotherapy who had a complete pathological response (n = 100),
- Arm B: Patients treated with neoadjuvant chemotherapy who had a residual cancer burden (n=100).
Planned study design: Include a prospective arm, Arm C to test feasibility of generating treatment predictions in real time.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Age: ≥ 18 years
- •Mental Capacity: Individual should be able to give informed consent, if alive
- •Triple Negative Breast Cancer (TNBC)
- •Oestrogen receptor (ER) negative with an Allred score of ≤ 2 or, equivalent pathology scoring system e.g., ≤10% (0 - 10%) tumour nuclei staining
- •HER2 negative: 1+ on immunohistochemistry or 2+ immunohistochemistry and FISH/D-Dish negative
- •Progesterone receptor (PgR) negative = PgR score of ≤2 or equivalent pathology scoring system e.g., ≤10% (0 - 10%) tumour nuclei staining
- •Androgen receptor (AR) status (if known): negative or positive
- •TNBC phenotype: HER2 negative tumours with borderline ER or PgR scoring on immunohistochemistry e.g., ER 3/8 and PgR 0/3 negative which were managed as early TNBC can be included but should be discussed on a case-by-case basis prior to study registration with Principal Investigator.
- •Lymph node involvement: Lymph node negative or positive; any number including clinical/pathological N3 involvement (TNM staging ≥ V.8.0)
- •Cancer Staging: Stage 2 or stage 3 breast cancer
- •Treated considered standard of care neoadjuvant chemotherapy: an anthracycline, a taxane, an alkylating agent, +/- a platinum, +/- immunotherapy
- •Available archival tissue samples
排除标准
- •Stage IV de novo metastatic breast cancer are not eligible
- •Stage I breast cancers are not eligible
- •Women who were diagnosed with more than one cancer type within 3 years of the breast cancer diagnosis of TNBC are not eligible
- •Received neoadjuvant radiotherapy
- •Received neoadjuvant endocrine treatment
- •Women pregnant at the time of the TNBC diagnosis
- •Significant medical co-morbidities which could have influenced the participant's prognosis are excluded. Examples include cardiac failure, moderate - severe renal failure, active hepatitis, HIV, active TB, ischaemic heart disease etc.
结局指标
主要结局
Validate accuracy of the Breast cancer therapeutic response predictive algorithm for predicting pathological complete response (pCR) in the early TNBC population treated with neoadjuvant chemotherapy.
时间窗: 24 months
Identify women with chemotherapy sensitive and chemotherapy resistant breast cancers.
时间窗: 24 months
次要结局
- Predict Overall Survival for women diagnosed with early TNBC following neoadjuvant chemotherapy.(24 months)
- Develop a risk of recurrence score for predicting the future probability of developing distant metastases in the early Triple Negative population.(24 months)
- Exploratory biomarker analyses of chemotherapy resistant tumour tissue post neoadjuvant chemotherapy.(24 months)
- Validate algorithm for predicting changes in tumour size in response to neoadjuvant treatment.(24 months)