NCT02257775

Terminated

Evolution of Resistance to Systemic Therapies in Patients Wi...

Institute of Cancer Research, United Kingdom Source

Institute of Cancer Research, United Kingdom

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

CCR4203

Study Type

observational

Actual enrollment (reported)

5

Locations

1 country

Sites

1

Timeline

Study Start

May 11, 2015

Actual (reported)

Primary Completion

November 23, 2017

Actual (reported)

Study Completion

November 23, 2017

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: terminated
Actual enrollment (reported): 5 participants
Study completion date: November 23, 2017
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
October 2, 2014
Actual (reported)
First Posted
October 6, 2014
Actual (reported)
Study Start
May 11, 2015
Actual (reported)
Primary Completion
November 23, 2017
Actual (reported)
Study Completion
November 23, 2017
Actual (reported)

Last Updated: January 30, 2018
Status Verified: January 2018
Last Update Submitted: January 26, 2018

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 - observationalGenetic

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

Patients requiring systemic therapy for metastatic breast cancer

You may qualify if:

Age over 18 years.

Sponsors & Collaborators

Institute of Cancer Research, United Kingdom
Otherlead

Study Sites (1)

The Royal Marsden

Sutton, SM2 5PT, United Kingdom

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

Jill Noble
Royal Marsden NHS Foundation Trust
PRINCIPAL INVESTIGATOR

Enrollment

5 participants (actual enrollment reported by the registry).

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

Actual (reported)

NCT02730858

Palliative and Oncology Care Model in Breast Cancer

Not ApplicableCompleted

NCT02662868

Metastatic Breast Cancer in Brazil: Characterization of Patients and Treatments

Completed

NCT02723877

PQR309 and Eribulin in Metastatic HER2 Negative and Triple-negative Breast Cancer (PIQHASSO)

Phase 1/2Completed

NCT02536742

Palbociclib in Molecularly Characterized ER-positive/HER2-negative Metastatic Breast Cancer

Phase 2Completed

NCT02102165

AURORA: Aiming to Understand the Molecular Aberrations in Metastatic Breast Cancer.

Not ApplicableRecruiting

NCT02473120

Study of ESR1 Mutations in Metastatic Breast Cancer

Not ApplicableCompleted

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

Contact the study team to confirm eligibility.

Primary Completion

November 23, 2017

Actual (reported)

Study Completion

November 23, 2017

Actual (reported)

Last Updated

January 30, 2018

Record last verified: 2018-01

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02257775
Data provider: ClinicalTrials.gov
Source updated: 2018-01-30
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:18:30 UTC

Locations

GB(1)

Study Stopped

Evolution of Resistance to Systemic Therapies in Patients With Breast Cancer

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations