Metastatic Breast CancerLEGACYNCT02126800
Rapid Medical Donation Programme for Breast Cancer
An observational study of Metastatic Breast Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2014to Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with proven metastatic breast cancer
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Marsden NHS Foundation Trust
London, SW3 6JJ
Sally Bennett, RN, +44 (0)20 7153 5004, LEGACY-BC@icr.ac.uk
About this study
Official title: Rapid Medical Donation Programme for Breast Cancer to Examine Tumour Heterogeneity
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.
Read more
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
- Conditions
- Metastatic Breast Cancer
- Keywords
- breast cancer
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
The acquisition of tumour tissue from multiple metastatic sites.
Measured: Within 6 hours from the time of death.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionSep 2017 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Breakthrough Breast Cancer, Institute of Cancer Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Peter A Barry, MB BS, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02126800
- Sponsor's protocol ID
- CCR3995
- Acronym
- LEGACY
- Status last verified
- Apr 2014
- First submitted
- 24 Apr 2014
- Last updated
- 30 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Medical Donation Programme for Breast Cancer to Examine Tumour Heterogeneity
- ClinicalTrials.gov ID
- NCT02126800
- Acronym / sponsor ID
- LEGACY / CCR3995
- Conditions
- Metastatic Breast Cancer
- Keywords
- breast cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Breakthrough Breast Cancer, Institute of Cancer Research, United Kingdom
- Study start
- Mar 2014
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 30 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with proven metastatic breast cancer
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The acquisition of tumour tissue from multiple metastatic sites.
Time frame: Within 6 hours from the time of death.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter A Barry, MB BS principal investigator
Royal Marsden NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Breast Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sally Bennett, RN (+44 (0)2073528171 ext. 1992, LEGACY-BC@icr.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The acquisition of tumour tissue from multiple metastatic sites. (time frame: Within 6 hours from the time of death.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2014.