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Predictive Model of Therapy Outcomes in Breast Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01563211
Recruitment Status : Completed
First Posted : March 26, 2012
Last Update Posted : March 26, 2015
Information provided by (Responsible Party):
Imperial College London

Brief Summary:

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.

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Study Type : Observational
Actual Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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).

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. Conduct cytokine analysis pre and post treatment, to determine relationship with severity of side effects experienced. [ Time Frame: 2 years ]
  3. 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.

  4. 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 ]
  5. 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
plasma/serum urine buffy coat - for purposes of DNA extraction

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients who have newly diagnosed primary breast cancer who will be receiving chemotherapy (FEC and FEC-D regimes only) or endocrine treatment (anastrozole, letrozole or tamoxifen only).

All new patients with Breast Cancer are discussed at the multidisciplinary team meeting (MDT) where they will be identified for the study. Patients will be identified by the oncologist and the multidisciplinary team (i.e the existing clinical care team).


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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01563211

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United Kingdom
Charing Cross Hospital
London, United Kingdom, W6 8RF
Sponsors and Collaborators
Imperial College London
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Principal Investigator: Charles Coombes Imperial College London
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Responsible Party: Imperial College London Identifier: NCT01563211    
Other Study ID Numbers: 72393/271478/14/611
11-LO-1644 ( Other Identifier: London Chelsea Research Ethics Committee )
First Posted: March 26, 2012    Key Record Dates
Last Update Posted: March 26, 2015
Last Verified: March 2012
Keywords provided by Imperial College London:
breast cancer therapy
side effect profile
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases