- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01479946
Electrochemotherapy For The Treatment Of Breast Cancer That Has Spread to the Skin
December 8, 2014 updated by: Jeffrey Yachnin, Uppsala University Hospital
An International Randomized Phase II Study Comparing Early Electrochemotherapy to Delayed or No Electrochemotherapy in Patients With Cutaneous Breast Cancer Metastases
Electroporation combined with chemotherapy (ECT) has been shown to be an effective treatment for breast cancer that has spread to skin.
In routine clinical practise, ECT is offered to patients when all other treatment options have been exhausted.
This study tests the hypothesis that early treatment with ECT may result in improved local control of skin metastases, improved quality of life and reduced health care costs.
Patients are randomised to either ECT given as early as possible in the course of the disease or delaying ECT for at least 6 months.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Uppsala, Sweden, 751 85
- Deaprtment of Oncology, University Hospital Uppsala
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female patients > 18 years of age
- Histological confirmed breast cancer
- Metastatic breast cancer (skin lesions only are considered as metastatic disease)
- Prior histological confirmation of at least one skin lesion
- Skin lesions must not have a depth greater than 3 cm (measured clinically if possible otherwise on the basis of CT/ultrasound examination
- Confluent skin metastases where individual lesions are hard to define in their entirety may not exceed a maximum area of 10 x 10 cm for each area of confluence. If there are several areas of confluence, the patient may be included in the study provided that all lesions can be treated within the time constraints of a single ECT session (20 minutes).
- Not more than ten skin lesions. Each area of confluence is considered as one lesion.
- A single skin lesion may not exceed 5 cm
- Patients may not have received more than one line of systemic treatment (chemotherapy or endocrine therapy) for metastatic disease following the discovery of skin metastases. Patients developing skin metastases for the first time during ongoing systemic therapy may receive one additional line of systemic treatment prior to inclusion.
- Patients in the early ECT arm may receive any other cancer treatments at the discretion of the treating physician starting no earlier than 2 weeks following ECT. This is to ensure that patients with metastatic disease in other locations will receive treatment that is considered suitable regardless of their participation in this trial. (If 2 weeks from ECT to the start of systemic treatment is judged to be too long by the treating physician, this patient should not be entered into the trial).
- Women of childbearing age must practice a suitable form of contraception.
- A life expectancy of at least 6 months.
- Patients with a ECOG performance status < 3
- Signed Informed Consent
Exclusion Criteria:
- Patients who have extensive and rapidly progressive visceral metastases where a delay in systemic therapy by eventual ECT is judged to not be in the patients' best interest
- Patients, who for medical reasons, cannot be given bleomycin
- Patients with brain metastases treated with surgery and/or radiotherapy who have progressive disease in the brain two months after treatment
- Prior cumulative dose of bleomycin exceeding 250,000 IU/m2
- Less than 14 days from previous cancer treatment (either local or systemic)
- If the patient has skin lesions that are situated in close proximity to a pacemaker such that an electrical field from ECT will overlap the pacemaker, the pacemaker must be moved to another location in order for the patient to be able to participate in the study
- Chronic renal failure (serum creatinine > 150 mol/L)
- Inadequate liver function defined as:
ASAT or ALAT > 2.5 x ULN in the absence of liver metastases or > 5 in the presence of liver metastases or Bilirubin > 2 x ULN (except in the case of Gilberts Syndrome) or Albumin < 25 g/L
• Inadequate bone marrow reserve defined as: White blood cell count < 3 X 109/L or Neutrophil count < 1.5 X109/L or Platelet count < 100 X 109/L
- Any severe uncontrolled systemic disease.
- Unable or unwilling to comply with the study protocol
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Early Electrochemotherapy
Electrochemotherapy is given as early as possible after the discovery of skin metastases
|
bleomycin together with electroporation
|
No Intervention: Delayed or no Electrochemotherapy
patients are to be treated for their breast cancer according to clinical routine with electrochemotherapy as an option only after 6 months from randomization
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
local control of skin metastases
Time Frame: 6 months from randomisation
|
6 months from randomisation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Local control of skin metastases during the time interval of 6 to 18 months after randomization
Time Frame: 18 months
|
The same measurement for local control as the primary endpoint
|
18 months
|
Quality of Life
Time Frame: monthly (up to 18 months)
|
EQ5D and FACT-B questionaires are to be filled on a monthly basis throughout the 18 month study period
|
monthly (up to 18 months)
|
Health economic analysis
Time Frame: recorded monthly (up to 18 months)
|
the number of out-patient visits, duration of hospital admissions if any, the number of type of systemic therapies, frequency of medical imaging and when applicable, the requirement for sick-leave.
|
recorded monthly (up to 18 months)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Jeffrey R Yachnin, MD, PhD, Uppsala University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2011
Primary Completion (Anticipated)
December 1, 2014
Study Completion (Anticipated)
June 1, 2015
Study Registration Dates
First Submitted
November 14, 2011
First Submitted That Met QC Criteria
November 25, 2011
First Posted (Estimate)
November 28, 2011
Study Record Updates
Last Update Posted (Estimate)
December 9, 2014
Last Update Submitted That Met QC Criteria
December 8, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CREATE-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Breast Cancer
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyActive, not recruitingStage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedMale Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
Northwestern UniversityEisai Inc.UnknownMale Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative...United States
-
University of WashingtonTerminatedBreast Cancer | Breast Cancer Stage I | Breast Cancer Stage II | Breast Cancer Stage III | Breast Cancer Stage IIB | Breast Cancer Stage IIA | Breast Cancer Stage IIIA | Breast Cancer Stage IIIB | Breast Cancer Stage IIIcUnited States
-
CelgeneCompletedBreast Cancer | Metastatic Breast Cancer | Stage IV Breast Cancer | Triple-negative Breast Cancer | Recurrent Breast Cancer | Breast Tumor | Cancer of the Breast | Triple-negative Metastatic Breast Cancer | Estrogen Receptor- Negative Breast Cancer | HER2- Negative Breast Cancer | Progesterone Receptor- Negative...United States, United Kingdom, Italy, Germany, Spain, Canada, Portugal, Australia, Austria, Greece, Brazil, France
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedHER2-positive Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Estrogen Receptor-negative Breast Cancer | Estrogen Receptor-positive Breast Cancer | Progesterone Receptor-negative Breast Cancer | Progesterone Receptor-positive Breast...United States
-
Baylor Breast Care CenterRecruitingBreast Cancer | Breast Neoplasm | Triple Negative Breast Cancer | Triple Negative Breast Neoplasms | HER2-positive Breast Cancer | Breast Cancer Stage II | Breast Cancer Female | Breast Cancer Stage III | Estrogen Receptor-positive Breast Cancer | Hormone Receptor-positive Breast Cancer | Breast Cancer InvasiveUnited States
-
Innocrin PharmaceuticalCompletedBreast Cancer | Advanced Breast Cancer | Metastatic Breast Cancer | Triple Negative Breast Cancer | Male Breast Cancer | ER+ Breast Cancer | Cancer of the BreastUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Male Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
Clinical Trials on Electrochemotherapy
-
IGEATerminatedColorectal Adenocarcinoma
-
University Women's Hospital TübingenCompleted
-
Universita di VeronaIGEATerminatedPancreatic CancerItaly
-
Copenhagen University Hospital at HerlevTerminated
-
Copenhagen University Hospital at HerlevWithdrawnUlcerated Cutaneous MetastasesDenmark
-
Institute of Oncology LjubljanaRecruiting
-
European Institute of OncologyMerck Sharp & Dohme LLCRecruiting
-
Sophie HorbachIGEAUnknownVascular Malformations | Capillary MalformationsNetherlands
-
Rigshospitalet, DenmarkCopenhagen University Hospital at HerlevUnknown
-
Institute of Oncology LjubljanaUniversity Medical Centre LjubljanaCompleted