Evolution of Resistance to Systemic Therapies in Patients With Breast Cancer

NCT02257775 | Terminated

• 1 other identifier: CCR4203
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Progression rate of skeletal metastases

  3 months

• Global and local lesion Apparent Diffusion Coefficient (ADC) distributions of WB-DWI scans within individual patient

  3 months

• Patient acceptability of WB-DWI assessed from questionnaires provided between WB-DWI scans and quantified using a 5-point Likert scale

  3 months

• Comparison of patient acceptability to whole-body CT

  3 months

Interventions

n/a - observational GENETIC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients requiring systemic therapy for metastatic breast cancer

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Cancer Research, United Kingdom: lead

Study Sites (1)

The Royal Marsden

Sutton, SM2 5PT, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jill Noble

  Royal Marsden NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2014
• First Posted: October 6, 2014
• Study Start: May 11, 2015
• Primary Completion: November 23, 2017
• Study Completion: November 23, 2017
• Last Updated: January 30, 2018

Record last verified: 2018-01

Locations

GB (1)