Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-24 @ 11:44 PM
NCT ID:
NCT02757651
Eligibility Criteria:
Inclusion Criteria:
* Age over 18 years
* Primary locally advanced breast cancer, or locally recurrent breast cancer with/without metastases
* Radical/high dose palliative radiotherapy required for lifetime control of local morbidities
* Patient physically and mentally fit for radical/high dose palliative radiotherapy
* Target tumour accessible for intra-tumoural injection
* At least one tumour diameter ≥30 mm measurable by ultrasound or magnetic resonance imaging
* Patient available for minimum 3 months follow up post-treatment prior to any surgical resection
* Negative pregnancy test within 7 days of starting radiotherapy in women of child bearing potential and an ability/willingness to protect against pregnancy for 3 months post- radiotherapy
* Patient offers written informed consent
Exclusion Criteria:
* Prior radiotherapy to the target area
* Anatomical location \&/or extent of disease difficult to access for safe intra-tumoural drug injections, for example by virtue of contiguous major blood vessels and/or brachial plexus
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02757651
Study Brief:
Protocol Section:
NCT02757651