Treatment of Primary Breast Cancer Using PDT

Not Applicable

Completed

• Conditions: Breast Neoplasms
• Interventions: Drug: Verteporfin

• Registration Number: NCT02872064
• Lead Sponsor: University College, London

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2016-08-15
• Study First Submitted QC: 2016-08-17
• Study First Posted: 2016-08-18
• Primary Completion: 2017-11
• Study Completion: 2017-12
• Status Verified: 2018-03
• Last Update Submitted: 2018-04-04
• Last Update Posted: 2018-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment with PDT	Verteporfin	A single intravenous injection of Verteporfin (0.4mg/kg) will be administered, at least 60minutes and up to 90 minutes before laser activation. A 690nm red laser light will be delivered with a diffuser laser fibre inserted through the skin into the breast tissue, with light dose escalation after every three patients. All patients will have fixed dose of the photosensitizer but variable light dose.

Primary Outcome Measures

Name	Time	Method
Establish the minimum effective light dose	One month	To establish the minimum light dose, in the range 20Joules/ (cm of light diffuser length) but not exceeding 90J/cm, required to induce an area of necrosis with a diameter of at least 12mm in line perpendicular to the fibre on microscopic examination or to achieve a plateau with no increasing necrosis as the light dose increases.

Secondary Outcome Measures

Name	Time	Method
Compare final histology with post PDT MRI.	One month	To assess the response of the Photodynamic Therapy on primary breast cancer via radiology using pre and post PDT MRI and comparing this with final histology. Measurements will be made of the diameter of necrosis on MRI scan which will be correlated with the histological measurement.
Assess affect of PDT on normal breast tissue.	One month	To look at the effect of Photodynamic Therapy on the abnormal breast tissue and study if necrosis extends to normal breast tissue.

Trial Locations

Locations (1)

Royal Free Hospital; 🇬🇧 London, United Kingdom