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

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.

Study Overview

• Status: Terminated
• Conditions: Metastatic Breast Cancer
• Intervention / Treatment: Genetic: n/a - observational

• Study Type: Observational
• Enrollment (Actual): 5

Contacts and Locations

Study Locations

• United Kingdom
  • Sutton, United Kingdom, SM2 5PT
    • The Royal Marsden

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients requiring systemic therapy for metastatic breast cancer

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression rate of liver metastases	Patients will be monitored by routine CT scans after 3 cycles of cytotoxic/biological therapy or after 3 months of endocrine therapy	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression rate of skeletal metastases	Patients will be monitored by routine CT scans after 3 cycles of cytotoxic/biological therapy or after 3 months of endocrine therapy	3 months
Global and local lesion Apparent Diffusion Coefficient (ADC) distributions of WB-DWI scans within individual patient	Patients will be monitored by routine CT scans after 3 cycles of cytotoxic/biological therapy or after 3 months of endocrine therapy	3 months
Patient acceptability of WB-DWI assessed from questionnaires provided between WB-DWI scans and quantified using a 5-point Likert scale	Patients will be monitored by routine CT scans after 3 cycles of cytotoxic/biological therapy or after 3 months of endocrine therapy	3 months
Comparison of patient acceptability to whole-body CT	Patients will be monitored by routine CT scans after 3 cycles of cytotoxic/biological therapy or after 3 months of endocrine therapy	3 months

Collaborators and Investigators

• Sponsor: Institute of Cancer Research, United Kingdom
• Investigators: Principal Investigator: Jill Noble, Royal Marsden NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2015
• Primary Completion (Actual): November 23, 2017
• Study Completion (Actual): November 23, 2017

Study Registration Dates

• First Submitted: October 2, 2014
• First Submitted That Met QC Criteria: October 2, 2014
• First Posted (Estimate): October 6, 2014

Study Record Updates

• Last Update Posted (Actual): January 30, 2018
• Last Update Submitted That Met QC Criteria: January 26, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: CCR4203