Status:
WITHDRAWN
An Imaging Study in ER Negative Breast Cancer by Targeting αvβ6
Lead Sponsor:
Queen Mary University of London
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This is a multicentre, pilot study that aims to determine the feasibility of \[18F\]-FBA-A20FMDV2-PET CT scans to detect levels of αvβ6 in patients with ER-ve αvβ6-positive metastatic or locally advan...
Detailed Description
Integrin alpha v beta six (αvβ6) is present in increased amounts on a number of cancer cells and is known to play a prominent role in cancer development and spread. FBA-A20FMDV2 is a substance that st...
Eligibility Criteria
Inclusion
- Able to give written informed consent prior to admission to this study.
- Female aged ≥18 years.
- ECOG performance status of 0-2.
- Histologically confirmed ER-ve metastatic or locally advanced breast cancer (latest available sample). ER-ve status defined as \<1% of tumour cells positive for ER on IHC or IHC score (Allred) ≤2. Any HER2 status is acceptable.
- At least one metastatic tumour site measuring ≥1cm in the longest diameter (except lymph nodes which must have a short axis of ≥1.5cm) as assessed by clinical imaging or by physical clinical evaluation.
- Biopsiable metastatic or locally advanced tumour sites, if a FFPE sample of current metastatic sites is not available. If an FFPE sample from the current metastatic sites is not available then patients must be willing to undergo an US or CT guided biopsy.
- Available FFPE tumour sample of the primary tumour prior to study entry for central assessment.
- Known αvβ6 status on primary or metastatic tumour (latest available) as defined by IHC.
- Patient must be progressing on current anti-cancer treatment (non-responder).
- Haematologic indices (FBC, WBC, ANC, platelets count and haemoglobin) and biochemical indices (sodium, potassium, chloride, urea, creatinine, total protein, albumin, total bilirubin, ALP and AST) within local institutional limits.
- Negative serum or urine pregnancy test for female patients of childbearing potential prior to study entry . Female patients of childbearing potential must agree to use adequate contraception as described in the protocol from the day of the scan and until 4 weeks after the last scan.
Exclusion
- Breast-feeding female patients.
- Previous or current exposure to animals that may harbour the foot and mouth disease virus FMDV2
- Previous long-term (≥ 3 months) residence in a country where FMDV2 is endemic (such as certain areas of Africa, Asia and South America).
- Planned to receive further anti-cancer treatment while on study.
- Subject feels unable to lie flat and still on their back for a period of up to 95 minutes in the PET/CT scanner.
- Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of the tracer, may affect the interpretation of the results, render the patient at high risk from treatment complications or interferes with obtaining informed consent.
Key Trial Info
Start Date :
June 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 27 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06978478
Start Date
June 19 2018
End Date
July 27 2020
Last Update
May 18 2025
Active Locations (1)
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1
Barts Health NHS Trust
London, United Kingdom, EC1M 6BQ