Abstract OT2-02-01: Photodynamic therapy for the treatment of primary breast cancer: Preliminary results of a phase I/IIa clinical trial

Background: Photodynamic therapy (PDT) has been used to treat skin metastases from breast cancer. We investigated the use of PDT for the treatment of primary breast cancer.Trial design: Phase I/IIA, open label, non-randomised, single site, light dose escalation trial in patients with primary breast cancer using verteporfin as the photosensitiser. Verteporfin 0.4mg/kg bodyweight is injected intravenously 60-90 minutes before laser activation through a thin optical fibre inserted percutaneously through a needle positioned under ultrasound guidance under local anaesthesia. The light dose is escalated from 20J to a maximum of 50J in intervals of 10J.Eligibility criteria: Patients aged 30 or over and have opted for mastectomy or wide local excision as primary treatment are included. The tumour should be uni-focal invasive ductal breast carcinoma, or discrete uni-focal site, within a multifocal invasive ductal carcinoma, in a single breast. Participants should not have confirmed distant metastases. The exclusion criteria include: patients who are not undergoing surgery as their primary treatment; patients undergoing surgery for DCIS without invasive breast cancer; lobular cancers and necrotic tumours; patients who have porphyria or are sensitive to verteporfin; patients who have severe cardiovascular disease or severe uncontrolled systemic disease (e.g. hepatic impairment); male breast cancer patients; pregnant or lactating patients; patients taking primary endocrine therapy or tak...
Source: Cancer Research - Category: Cancer & Oncology Authors: Tags: Ongoing Clinical Trials Source Type: research