Treatment of Primary Breast Cancer Using PDT
Treatment of Primary Breast Cancer Using PDT
Phase I/IIA, open label, non-randomised, single site trial in patients with primary breast
 cancer.
This is a phase I / IIa study recruiting patients diagnosed with primary breast cancer.
 Patients who have chosen mastectomy or wide local excision as their surgical option will be
 included. Patients will have a pre therapy MRI followed by photodynamic therapy. PDT involves
 intravenously injecting the photosensitizer Verteporfin (Visudyne) drug. This drug makes the
 tumour sensitive to light. A non-thermal light will then be shone in the tumour which brings
 about tissue necrosis (destruction). Although the drug dose will remain the same, the light
 dose will be escalated depending on patient response in accordance to a predefined algorithm
 (see section) to achieve a zone of necrosis of 12mm or a plateau of necrosis with incremental
 increase in light dose. An MRI will be performed immediately prior to the scheduled surgery.
 Pre and post PDT MRI changes will be correlated with the histological findings on the excised
 breast specimen. Should the minimum light dose for 12mm necrosis be established recruitment
 will continue until 12 patients have received this dose. These 12 patients will provide
 sample data on the size of tumour and area of necrosis detected by MRI and histology to
 enable sample size (power) calculations for future studies of PDT in primary breast cancer.
 This is a dose escalation study involving a minimum of twelve and a maximum of forty
 patients.
Inclusion Criteria:

 1. Patients aged 30 or over

 2. A uni-focal invasive ductal breast carcinoma or discrete uni-focal site which is
 deemed suitable for PDT within a multifocal invasive ductal carcinoma in a single
 breast.

 3. Patients who have opted for mastectomy or wide local excision as primary treatment.

 4. Capable of giving written informed consent

 Exclusion Criteria:

 1. Patients who are not undergoing surgery as their primary treatment.

 2. Patients undergoing surgery for DCIS without invasive breast cancer.

 3. Patients with Lobular cancer

 4. Patients with Necrotic tumours

 5. Distant metastatic disease.

 6. Patients will be excluded if they have porphyria or are sensitive to verteporfin
 (visudyne).

 7. Patients who have severe cardiovascular disease.

 8. Patients with severe or uncontrolled systemic disease e.g. hepatic impairment.

 9. Patients with laboratory findings that make it undesirable for the patient to
 participate in the trial.

 10. Male breast cancer patients

 11. Pregnancy and lactation.

 12. No patients with any psychiatric disorder making reliable informed consent impossible.

 13. Patients will be excluded if taking part in any other trial of an experimental
 medicine

 14. Patients will be excluded if taking endocrine therapy drugs that could confound the
 results.