Treatment of Primary Breast Cancer Using PDT

• Status: Completed
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

Phase I/IIA, open label, non-randomised, single site trial in patients with primary breast cancer.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University College, London
• Treatments: Verteporfin

Criteria

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.