Predictive Model of Therapy Outcomes in Breast Cancer Patients

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.

Sex

Female

Minimum age

18 Years

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.