Predictive Modelling of Short Term Outcomes Following Systemic Neo-adjuvant and Adjuvant Therapy in Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- The primary outcome measure for the study is to determine the relationship between metabonomics spectrum and side effects from chemotherapy and endocrine therapy for patients receiving treatment for breast cancer.
研究概览
简要总结
Patients with breast cancer, who are treated with curative intent, have a combination of surgery (excision of the tumor) and a course of medical therapy (chemotherapy or endocrine treatment). Both treatments are associated with significant side effects. Chemotherapy is associated with nausea, vomiting, hair loss and bone marrow suppression, whereas endocrine therapy is associated with arthritis and menopausal symptoms. Patients taking either chemotherapy or endocrine treatment may experience a range of side effects. The range and severity of side effects experienced vary from patient to patient. Little or nothing is known about the reason for this difference.
The aim of the investigators proposal is to develop a pretreatment test to identify patients who are likely to undergo moderate to severe side effects, and therefore help doctors and patients plan and optimize medical therapy. The pretreatment test will be based on identifying a metabolic profile which can differentiate those patients who are likely to have severe or moderate side effects from those with either no or mild side effects. To do this, the investigators will take urine and blood samples from patients before and after the administration of endocrine treatment or chemotherapy and generate metabolic profiles.
Furthermore, the investigators aim to gain an understanding into why side effects experienced between different patients are so variable. To do this the investigators plan to perform cytokine analysis, targeted genetic analysis and pharmaokinetic analysis on blood sample collected from patients before and after treatment has commenced. Patients who have planned surgical excision of tumor and are recommended to receive medical therapy before or after surgery would be invited to join the study. Each patient will be required to make additional visits to the hospital to complete questionnaires regarding side effects experienced and for sample (urine and blood) collection. The investigators plan to recruit 168 patients.
详细描述
Patients with breast cancer are treated with a combination of surgery and medical treatment (either before (neoadjuvant) or after (adjuvant) surgery). Eligible patients will be identified by the oncologist and from the multidisciplinary meeting.
Once eligible patients have been identified they will be informed of the study by their oncologist, and then approached by the research team who will give them a patient information leaflet, discuss the study, answer any questions and ask the patient to sign a consent form if they are would like to participate in the study. The consent form must be signed before any study related procedures are performed.
Patients who have had surgery prior to receiving medical treatment (i.e. patients planned to receive adjuvant treatment, or patients who have a sentinel lymph node biopsy prior to starting neoadjuvant treatment) will have blood and urine samples taken before they have their surgery, at the preassessment surgical appointment.
The week before the patient starts medical therapy (either chemotherapy or endocrine treatment) the patient will need to attend Charing Cross Hospital for the following procedures (this may be an extra visit, depending on hospital appointments):
- To see the study doctor for a medical history and physical examination
- Pulse and blood pressure measurements
- BMI (body mass index) and body fat assessment
- To fill out a quality of life (QOL) questionnaire with research staff
- Routine blood tests (for haematology and biochemistry)
- Blood sample for metabolic profiling and cytokine analysis
- Urine sample for metabolic profiling
- The blood taken will additionally be tested for targeted genetic analysis if the patient has consented for this (as this is optional)
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
- •Histologically proven breast cancer.
- •Female ≥ 18 years of age, no upper age limit.
- •Pretreatment haematology and biochemistry values with acceptable limits:
- •Haemoglobin (Hb) > 9g/dl
- •Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) ≤ 1.5 x ULN
- •Serum bilirrubin ≤ 1.5 x ULN
- •Alkaline phosphatase ≤ 1.5 x ULN
- •White blood cell (WBC) count ≥ 3.0 x 109/L and absolute neutrophil count (ANC) ≥ 1.5 x 109/L
- •Platelets ≥ 100 x 109/L
- •Serum creatinine ≤ 1.5 x ULN
- •WHO performance status 0 or 1
- •No active or uncontrolled infection
- •Written informed consent prior to commencement of specific protocol procedures
- •No concomitant medical, psychiatric or geographical problems that might prevent follow up of symptoms according to protocol.
排除标准
- •Other serious illness or medical condition:
- •Congestive heart failure or unstable angina pectoris, previous history of myocardial infarction within 1 year prior to study entry, uncontrolled hypertension or high risk of uncontrolled arrhythmias
- •History of significant neurological or psychiatric disorders including psychotic disorders, dementia or seizure that would prohibit the understanding and giving of informed consent
- •Active uncontrolled infection
- •Active peptic ulcer, unstable diabetes mellitus
- •Only cytological proof of malignancy
- •Patients not able or willing to give informed consent
- •Patients taking medication other than low dose aspirin, antihypertensives or statins.
结局指标
主要结局
The primary outcome measure for the study is to determine the relationship between metabonomics spectrum and side effects from chemotherapy and endocrine therapy for patients receiving treatment for breast cancer.
时间窗: 2 years
To identify a pre-treatment metabolic profile to predict patients who will experience moderate to severe side effects.
次要结局
- Conduct cytokine analysis pre and post treatment, to determine relationship with severity of side effects experienced.(2 years)
- Conduct targeted genetic analysis to determine relationship with severity of side effects experienced.(2 years)
- Conduct pharmokinetic analysis of drugs administered and determine relationship between pharmacokinetics and severity of side effects experienced.(2 years)
- To find underlying mechanism to explain the interpatient variability in severity of side effects experienced using above techniques (i.e. metabolic profile, pharmacokinetic analysis, cytokine analysis and targeted genetic analysis).(2 years)
- To identify a biomarker based on metabnomic profiling for response to treatment for those receiving neoadjuvant treatment.(2 years)