Treatment of Primary Breast Cancer Using PDT

Breast Neoplasms Clinical Trial

Official title:

A Phase I/IIa, Open Label, Single Site Light Dose Escalation Trial of Single Dose Verteporfin Photodynamic Therapy (PDT) in Primary Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02872064
• Other study ID #: 09/0286
• Status: Completed
• Phase: N/A
• First received: August 15, 2016
• Last updated: April 4, 2018
• Start date: January 2013
• Est. completion date: December 2017

Study information

• Verified date: March 2018
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Drug:
• Verteporfin
Verteporfin (which is marketed under the brand name Visudyne) is the photosensitizer. Verteporfin is a benzoporphyrin derivative which is clinically active when formulated with liposomes. By itself the clinically recommended dose of Verteporfin is not cytotoxic. It produces cytotoxic agents only when activated by light in the presence of oxygen. When energy absorbed by the porphyrin is transferred to oxygen, highly reactive short lived singlet oxygen is generated. Singlet oxygen causes damage to biological structures, leading to local vascular occlusion, cell damage and cell death.

Locations

Country	Name	City	State
United Kingdom	Royal Free Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Establish the minimum effective light dose	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.	One month
Secondary	Compare final histology with post PDT MRI.	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.	One month
Secondary	Assess affect of PDT on normal breast tissue.	To look at the effect of Photodynamic Therapy on the abnormal breast tissue and study if necrosis extends to normal breast tissue.	One month