Predictive Model of Therapy Outcomes in Breast Cancer Patients
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|ClinicalTrials.gov Identifier: NCT01563211|
Recruitment Status : Completed
First Posted : March 26, 2012
Last Update Posted : March 26, 2015
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.
|Condition or disease|
|Toxicity From Medication (Endocrine Treatment and Chemotherapy) Given for Breast Cancer Treatment.|
|Study Type :||Observational|
|Actual Enrollment :||70 participants|
|Official Title:||Predictive Modelling of Short Term Outcomes Following Systemic Neo-adjuvant and Adjuvant Therapy in Breast Cancer Patients|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||August 2014|
Patients receiving endocrine treatment for breast cancer
Patients who are treated with tamoxifen, anastrozole or letrozole before or after surgery for breast cancer.
Patients receiving chemotherapy for breast cancer
Patients receiving FEC (5-FU, cyclophosphamide, epiribicin) or FEC-D (FEC for 3 cycles, followed by 3 cycles of docetaxel).
- 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. [ Time Frame: 2 years ]To identify a pre-treatment metabolic profile to predict patients who will experience moderate to severe side effects.
- Conduct pharmokinetic analysis of drugs administered and determine relationship between pharmacokinetics and severity of side effects experienced. [ Time Frame: 2 years ]Measure pharmokinetics of each drug to try and ascertain underlying reasons for differences in toxicity.
- Conduct cytokine analysis pre and post treatment, to determine relationship with severity of side effects experienced. [ Time Frame: 2 years ]
- Conduct targeted genetic analysis to determine relationship with severity of side effects experienced. [ Time Frame: 2 years ]To identify known SNPs implicated in toxicity to metabolic profile/biomarkers found.
- 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). [ Time Frame: 2 years ]
- To identify a biomarker based on metabnomic profiling for response to treatment for those receiving neoadjuvant treatment. [ Time Frame: 2 years ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01563211
|Charing Cross Hospital|
|London, United Kingdom, W6 8RF|
|Principal Investigator:||Charles Coombes||Imperial College London|