Breast Cancer Evolution During Neoadjuvant Systemic Therapy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRoyal Marsden NHS Foundation Trust
About this trial
BELIEVE is a translational research study that aims to collect samples of breast cancer tissue and blood from individuals undergoing breast cancer treatment (such as chemotherapy, targeted therapy and immunotherapy) before surgery. In certain cases, MRI scans and stool samples will also be obtained before and during treatment. The samples collected from this study will be used for molecular and genetic research to understand why some cancers respond very well to anticancer treatments, and some do not, develop novel ways of accurately measuring response during treatment, as well as identify which patients are at a higher risk of the cancer coming back after surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically confirmed non-metastatic invasive breast cancer.
Be suitable for, but have not commenced, neoadjuvant chemotherapy, targeted therapy, or immunotherapy.
If HER2-, suitable for treatment with upfront taxane chemotherapy. If HER2+, suitable for treatment with anti-HER2 targeted therapy.
Be aged 18 years and over.
Disqualifiers
Metastatic breast cancer at diagnosis.
Treatment with neoadjuvant endocrine therapy only.
Presence of any psychological, familial or sociological condition potentially hampering compliance with the study protocol and follow-up schedule.
Trial population
Early breast cancer patients suitable for neoadjuvant chemotherapy, targeted therapy, or immunotherapy.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Proportion of patients recruited undertaking sequential tumour biopsies, blood samples, and MRI.
Time frame
Total 10 year recruitment period2
Proportion of patients undergoing study procedures within time frames specified by protocol.
Time frame
Total 10 year recruitment periodSecondary outcomes
1
Characterisation of serial molecular and imaging tumour and host profiles and correlation with clinical characteristics, treatment responses and patient outcomes.
Time frame
Total 10 year recruitment period2
Integration of multiplatform profiling data to develop predictors of response to therapy.
Time frame
Total 10 year recruitment periodSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov