Evolution of Resistance to Systemic Therapies in Patients With Breast Cancer

Metastatic Breast Cancer Clinical Trial

— EVOLUTION  

Official title:

Evolution of Resistance to Systemic Therapies in Patients With Breast Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02257775
• Other study ID #: CCR4203
• Status: Terminated
• Phase: N/A
• First received: October 2, 2014
• Last updated: January 26, 2018
• Start date: May 11, 2015
• Est. completion date: November 23, 2017

Study information

• Verified date: January 2018
• Source: Institute of Cancer Research, United Kingdom
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: November 23, 2017
• Est. primary completion date: November 23, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Genetic:
• n/a - observational

Locations

Country	Name	City	State
United Kingdom	The Royal Marsden	Sutton

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Cancer Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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