Rapid Medical Donation Programme for Breast Cancer

Metastatic Breast Cancer Clinical Trial

— LEGACY  

Official title:

Rapid Medical Donation Programme for Breast Cancer to Examine Tumour Heterogeneity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02126800
• Other study ID #: CCR3995
• Status: Recruiting
• Phase: N/A
• First received: April 24, 2014
• Last updated: April 28, 2014
• Start date: March 2014
• Est. completion date: March 2019

Study information

• Verified date: April 2014
• Source: Royal Marsden NHS Foundation Trust
• Contact: Sally Bennett, RN
• Phone: +44 (0)2073528171
• Email: LEGACY-BC[@]icr.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial Summary

Treatment of breast cancer has traditionally been based on the primary tumour's features in the breast. Only recently, when cancer returns at other sites, has there been an attempt to biopsy the metastatic disease and change treatments accordingly. A 'repeat biopsy' can be technically difficult, painful and, when possible, only represents a small sample of one of many metastases.

Even when one deposit responds to a new treatment, a neighbouring one may continue to grow. There is an urgent need to characterise all deposits, particularly the lethal ones which progress despite all treatments.

This study will enable the comprehensive analysis of the metastatic process and the evolution of the breast cancer through the course of its treatment. Patients who have consented during life to donate their tissues for molecular analysis will provide the means for such an analysis.

Main aims:

• To comprehensively and systematically examine metastatic breast cancer by its detailed exploratory molecular characterization to elucidate the possible inter- and intratumoural heterogeneity between the primary tumour and the majority of metastatic sites.

• To map the natural history of the metastatic breast cancer process

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2019
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who have completed active treatment (or trials) for metastatic breast cancer.

• Patients referred to either community or the hospital-based palliative care unit from Royal Marsden National Health Service Foundation Trust.

Exclusion Criteria:

• Lack of capacity / inability to give informed consent.

• Diagnosis of alternative cancer within the last 5 years other than resected basal cell skin cancer or cervical intraepithelial neoplasia.

• Patients known to be HIV, Hepatitis B virus or Hepatitis C virus positive on serology .

• Spongiform encephalopathy (known or suspected CJD) .

• Eligibility for or current participation in a clinical trial (excluding palliative care trials)

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Locations

Country	Name	City	State
United Kingdom	Royal Marsden NHS Foundation Trust	London

Sponsors (3)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust	Breakthrough Breast Cancer, Institute of Cancer Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The acquisition of tumour tissue from multiple metastatic sites.		Within 6 hours from the time of death.	No