Feasibility of Serial Multisite Image-guided Biopsy to Study Breast Cancer Evolution
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRoyal Marsden NHS Foundation Trust
About this trial
FORTITUDE is a translational research study that aims to collect serial multi-site needle biopsy samples of tumour tissue and blood from metastatic breast cancer patients. Cancer biopsies are generally performed when cancer is diagnosed and are sometimes repeated when the cancer is suspected to have spread but this is not mandatory. However, studies have shown that cancers change with time and evolve to become resistant to therapy. The purpose of this study is to assess the feasibility of biopsies of multiple cancer sites across different time points during treatment and understand how cancers evolve and change throughout treatment. The findings of this study could pave the way for using cancer biopsies more frequently in the clinic to pick up changes in cancer behaviour that could influence treatment choice. The samples collected from this study will be used for molecular and genetic research to increase our understanding of how metastatic breast cancer changes during treatment and will enable us to develop new cancer treatments and new ways of monitoring response to cancer therapies.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically confirmed locally advanced, inoperable breast cancer or metastatic breast cancer OR radiological evidence of metastatic disease with a high index of suspicion that this is a recurrence of a previously diagnosed breast cancer.
Be aged 18 years and over.
Have given written informed consent to participate.
Disqualifiers
Metastatic disease limited to bones, without a soft tissue component.
Any bleeding disorders or anticoagulation that cannot be corrected and that would render the risk of biopsy unacceptable.
If the consultant physician involved in the care of the patient assesses and decides the risk of the biopsy procedures is significant, defined as greater than 1% risk of significant complication.
Eastern Cooperative Oncology Group performance status of 3 and higher.
Trial population
Metastatic breast cancer or locally advanced, inoperable breast cancer patients.
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 having two or more tumour sites sampled in one procedural sitting when technically feasible
Time frame
Through study completion, 15 years2
Proportion of patients having longitudinal sampling in those progressing on treatment
Time frame
Through study completion, 15 years3
Proportion of patients willing to undergo multisite sampling again in the future if clinically required
Time frame
Through study completion, 15 yearsSecondary outcomes
1
Quantification of procedural complication rates
Time frame
Through study completion, 15 years2
Quantification of duration of biopsy procedures
Time frame
Through study completion, 15 years3
Accuracy of tumour biopsies
Accuracy may be defined as the successful identification of tumour tissue through biopsy, as confirmed by histopathology examination, or by other exploratory means such as using CT images to measure actual needle tip position compared to planning scans
Time frame
Through study completion, 15 years4
Quantification of proportion of samples adequate for molecular profiling
Time frame
Through study completion, 15 yearsSponsors and contacts
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Source ClinicalTrials.gov