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Evolution of Resistance to Systemic Therapies in Patients With Breast Cancer (EVOLUTION)

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.
 
ClinicalTrials.gov Identifier: NCT02257775
Recruitment Status : Terminated (Insufficient number of eligible and interested partients)
First Posted : October 6, 2014
Last Update Posted : January 30, 2018
Sponsor:
Information provided by (Responsible Party):
Institute of Cancer Research, United Kingdom

Brief Summary:
The objective of this study is to apply Whole-body DW imaging alongside the routine management of patients requiring systemic therapy for metastatic breast cancer to compare the time to progression of individual liver metastases within and between patients following stable disease or partial response to palliative systemic therapy for breast cancer.

Condition or disease Intervention/treatment
Metastatic Breast Cancer Genetic: n/a - observational

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Study Type : Observational
Actual Enrollment : 5 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evolution of Resistance to Systemic Therapies in Patients With Breast Cancer
Actual Study Start Date : May 11, 2015
Actual Primary Completion Date : November 23, 2017
Actual Study Completion Date : November 23, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer




Primary Outcome Measures :
  1. Progression rate of liver metastases [ Time Frame: 3 months ]
    Patients will be monitored by routine CT scans after 3 cycles of cytotoxic/biological therapy or after 3 months of endocrine therapy


Secondary Outcome Measures :
  1. Progression rate of skeletal metastases [ Time Frame: 3 months ]
    Patients will be monitored by routine CT scans after 3 cycles of cytotoxic/biological therapy or after 3 months of endocrine therapy

  2. Global and local lesion Apparent Diffusion Coefficient (ADC) distributions of WB-DWI scans within individual patient [ Time Frame: 3 months ]
    Patients will be monitored by routine CT scans after 3 cycles of cytotoxic/biological therapy or after 3 months of endocrine therapy

  3. Patient acceptability of WB-DWI assessed from questionnaires provided between WB-DWI scans and quantified using a 5-point Likert scale [ Time Frame: 3 months ]
    Patients will be monitored by routine CT scans after 3 cycles of cytotoxic/biological therapy or after 3 months of endocrine therapy

  4. Comparison of patient acceptability to whole-body CT [ Time Frame: 3 months ]
    Patients will be monitored by routine CT scans after 3 cycles of cytotoxic/biological therapy or after 3 months of endocrine therapy



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients requiring systemic therapy for metastatic breast cancer
Criteria

Inclusion Criteria:

  • Age over 18 years.
  • First metastatic breast cancer relapse after treatment for early stage disease
  • A minimum of 10 evaluable lesions in the liver on routine x-ray CT imaging
  • Patient prescribed cytotoxic, endocrine or biological therapies
  • Patient physically and psychologically fit enough to consider sequential WB-- - DWI imaging alongside their standard disease monitoring
  • Written informed consent

Exclusion Criteria:

  • Diagnosis of other cancer within the last 5 years, other than resected non-melanoma skin cancer or cervical intraepithelial neoplasia
  • Diagnosis of brain metastases.
  • Contraindication to magnetic resonance MR imaging

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 ClinicalTrials.gov identifier (NCT number): NCT02257775


Locations
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United Kingdom
The Royal Marsden
Sutton, United Kingdom, SM2 5PT
Sponsors and Collaborators
Institute of Cancer Research, United Kingdom
Investigators
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Principal Investigator: Jill Noble Royal Marsden NHS Foundation Trust
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Responsible Party: Institute of Cancer Research, United Kingdom
ClinicalTrials.gov Identifier: NCT02257775    
Other Study ID Numbers: CCR4203
First Posted: October 6, 2014    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases