A Phase 2 interventional study of Electrochemotherapy in Breast Cancer, sponsored by Copenhagen University Hospital at Herlev. Terminated at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-07-18.
Sponsored by Copenhagen University Hospital at Herlev · Phase 2, Interventional, and Treatment
By applying short electric pulses to cells, the cell membranes can become permeabilised (electroporation). This can be used augment the effect of chemotherapy, by providing direct access to the cell cytosol. For the drug bleomycin, the enhancement of effect is several hundred fold, enabling once-only treatment. We wish to offer electrochemotherapy to breast cancer patients suffering from chest wall recurrences that are ulcerated or painful and where other treatments have failed.
Electrochemotherapy for chest wall recurrence of breast cancer. MD, Ph.D. student, Louise Wichmann Matthiessen, has been employed in 2008 to perform this study. She plans to complete her training as specialist in clinical oncology subsequently, and will thus be able to follow up the work after completion of her Ph.D. The study aims at giving palliation to patients who are suffering from painful, ulcerated metastases to the chest wall in a situation where other treatments have failed.
Inclusion criteria: Chest wall recurrence of breast cancer; all other modalities have failed or patients does not wish to receive them (e.g. chemotherapy); symptomatic relief is needed; WHO performance status 0-2; normal coagulation parameters, normal kidney and renal function; written, informed consent. Lesions totalling over 3 cm in diameter. Patient recruitment: 28 patients are to be recruited.
Treatment: Patients will be treated in general anesthesia (inhaling max. 30 % oxygen), and a standard dose of bleomycin (15.000 IU/ m2) will be given intravenously. Electric pulses will be administered using a square wave electroporator (IGEA, Carpi, Italy). Needle and plate electrodes are used in order to treat the affected area efficiently. Eight pulses at a frequency of 5 kHz will be used for each application of the electrodes. In this way, a large area can be treated within a short time. Post treatment, the area will be covered by dry dressings, as are standardly used.
The patients will be seen at 2, 4, and 8 weeks post treatment, and re-treatment can be administered up to three times in case there are areas which have not been insufficiently treated in the first round. Lung function will be followed by measurement of DLCO (carbon monoxide diffusion capacity).
The patients will furthermore be followed up to 1 year after treatment in monthly intervals, and after 1 year on a yearly basis for up to 5 years.
Evaluation: Evaluation is performed by a) measurement of lesion extension and digital photography, b) development of a mapping system: Chest wall recurrences are frequently a confluent mass of tumor with varying depth. Precise mapping of treatment areas and effect is warranted. To this end, a system combining a fixed point (e.g. small ink tattoo, as used in radiotherapy planning) with novel imaging techniques using the 3D computer tomography (CT) planning system employed for radiotherapy, is envisaged. Furthermore, PET-Dual Time Point scanning combined with CT scanning is being investigated as treatment evaluation.
Safety: Safety will be reported both in terms of evaluation of adverse events and in terms of patient satisfaction determined by questionnaire, including the 'Derriford Appearance Questionaire'(18).
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 17 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Copenhagen University Hospital at Herlev is the lead sponsor of 76 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients with local-regional recurrence of breast cancer, lesion over 3 cm.
Procedure: Electrochemotherapy
Electric pulses , duration 100 microseconds, about 400 V given at 5000 Hz. Drug used is Bleomycin.
Also known as: Device: Cliniporator, Drug: Bleomycin
Clinical Measure of Lesion Size.
Response was evaluated clinical using Response Evaluation Criteria in Solid Tumors (RECIST) guidelines and documented with digital photography. Number of patients with objective response evaluated with clinical measure of lesion size
Time frame: up to one year
Participants With Objective Response Evaluated With PET/CT
Participants with objective response evaluated with PET/CT. Objective Response evaluated with CT and PET/CT.
Time frame: 3, weeks, 8 weeks, and up to 6 months after treatment
Safety and Toxicity
Time frame: up to 1 year
recruitment period: October 2008 to November 2010. Total of 17 patients included and treated with electrochemotherapy.
| Milestone | Electrochemotherapy |
|---|---|
| Started | 17 |
| Completed | 1 |
| Not completed | 16 |
| Withdrew: Antineoplastic treatment | 11 |
| Withdrew: Death | 1 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Physician decision | 3 |
Response was evaluated clinical using Response Evaluation Criteria in Solid Tumors (RECIST) guidelines and documented with digital photography. Number of patients with objective response evaluated with clinical measure of lesion size
| Participants | Electrochemotherapy |
|---|---|
| Clinical Measure of Lesion Size. | 2 |
Participants with objective response evaluated with PET/CT. Objective Response evaluated with CT and PET/CT.
| participants | Electrochemotherapy |
|---|---|
| Participants With Objective Response Evaluated With PET/CT | 4 |
| adverse events | Electrochemotherapy |
|---|---|
| Safety and Toxicity | 0 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Electrochemotherapy | — | 0/17 (0%) | 0/17 (0%) |
| Age, Categorical(Participants) | Electrochemotherapy |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 12 |
| >=65 years | 5 |
| Age, Continuous(years) | Electrochemotherapy |
|---|---|
| Mean | 58.6 ± 9.8 |
| Sex: Female, Male(Participants) | Electrochemotherapy |
|---|---|
| Female | 17 |
| Male | 0 |
| Region of Enrollment(participants) | Electrochemotherapy |
|---|---|
| Denmark | 17 |
This study is terminated, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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Copenhagen University Hospital at Herlev