Clinical trial NCT02872064: Treatment of Primary Breast Cancer Using PDT
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasms
Keywords: Early breast cancer
Photodynamic therapy
PDT
Visudyne
Verteporfin
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2016-08-18
Enrollment: 12
Sex: FEMALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Establish the minimum effective light dose
timeFrame: One month
Secondary outcomes:
measure: Compare final histology with post PDT MRI.
timeFrame: One month
measure: Assess affect of PDT on normal breast tissue.
timeFrame: One month
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal Free Hospital
Study officials:
affiliation: Royal Free NHS Trust
name: Mo RS Keshtgar
role: PRINCIPAL_INVESTIGATOR
References: