Predictive Model of Therapy Outcomes in Breast Cancer Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Imperial College London.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01563211
First received: January 25, 2012
Last updated: March 22, 2012
Last verified: March 2012
  Purpose

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
Toxicity From Medication (Endocrine Treatment and Chemotherapy) Given for Breast Cancer Treatment.

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    To identify a pre-treatment metabolic profile to predict patients who will experience moderate to severe side effects.


Secondary Outcome Measures:
  • Conduct pharmokinetic analysis of drugs administered and determine relationship between pharmacokinetics and severity of side effects experienced. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
  • Conduct targeted genetic analysis to determine relationship with severity of side effects experienced. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
  • To identify a biomarker based on metabnomic profiling for response to treatment for those receiving neoadjuvant treatment. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

plasma/serum urine buffy coat - for purposes of DNA extraction


Estimated Enrollment: 168
Study Start Date: February 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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).

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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).

Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01563211

Contacts
Contact: Charles Coombes 02083835828 c.coombes@imperial.ac.uk

Locations
United Kingdom
Charing Cross Hospital Recruiting
London, United Kingdom, W6 8RF
Contact: Charles Professor Coombes, MBBS MD PhD FMedSci         
Principal Investigator: Charles Professor Coombes, MBBS MD PhD FMedSci         
Sponsors and Collaborators
Imperial College London
Investigators
Principal Investigator: Charles Coombes Imperial College London
  More Information

No publications provided

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01563211     History of Changes
Other Study ID Numbers: 72393/271478/14/611, 11-LO-1644
Study First Received: January 25, 2012
Last Updated: March 22, 2012
Health Authority: United Kingdom: National Health Service

Keywords provided by Imperial College London:
breast cancer therapy
toxicity
side effect profile

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 30, 2014