Breast CancerPhase 2NCT01479946
Electrochemotherapy For The Treatment Of Breast Cancer That Has Spread to the Skin
A Phase 2 study testing Electrochemotherapy in people with Breast Cancer and Skin Metastases, run by Uppsala University Hospital at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Skin Metastases
- What is being tested?
- Electrochemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2011to Jun 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Deaprtment of Oncology, University Hospital Uppsala
Uppsala, 751 85
About this study
Official title: 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.
- Conditions
- Breast Cancer, Skin Metastases
- Being tested
- Electrochemotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectrochemotherapyDrug
bleomycin together with electroporation
| Study group | Role | What they receive |
|---|---|---|
| Early Electrochemotherapy | Experimental | Electrochemotherapy is given as early as possible after the discovery of skin metastases Receives: Drug: Electrochemotherapy |
| Delayed or no Electrochemotherapy | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
local control of skin metastases
Measured: 6 months from randomisation
Secondary outcomes (3)
Local control of skin metastases during the time interval of 6 to 18 months after randomization
The same measurement for local control as the primary endpoint
Measured: 18 months
Quality of Life
EQ5D and FACT-B questionaires are to be filled on a monthly basis throughout the 18 month study period
Measured: monthly (up to 18 months)
Health economic analysis
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.
Measured: recorded monthly (up to 18 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2014 (estimated)
- Study completionJun 2015 (estimated)
Why it stopped: ECT equipment not available at study center
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Yachnin, Uppsala University Hospital
- Investigators
- Jeffrey R Yachnin, MD, PhD, Study director, Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01479946
- Sponsor's protocol ID
- CREATE-01
- Status last verified
- Dec 2014
- First submitted
- 14 Nov 2011
- Last updated
- 9 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International Randomized Phase II Study Comparing Early Electrochemotherapy to Delayed or No Electrochemotherapy in Patients With Cutaneous Breast Cancer Metastases
- ClinicalTrials.gov ID
- NCT01479946
- Acronym / sponsor ID
- CREATE-01
- Conditions
- Breast Cancer, Skin Metastases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: ECT equipment not available at study center
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Uppsala University HospitalUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 28 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Electrochemotherapy | Experimental | Drug: ElectrochemotherapyElectrochemotherapy is given as early as possible after the discovery of skin metastases |
| Delayed or no Electrochemotherapy | No intervention | –patients are to be treated for their breast cancer according to clinical routine with electrochemotherapy as an option only after 6 months from randomization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrochemotherapybleomycin together with electroporation | Drug | Early Electrochemotherapy |
Primary outcome
local control of skin metastases
Time frame: 6 months from randomisation
3 secondary outcomes
Local control of skin metastases during the time interval of 6 to 18 months after randomization
Time frame: 18 months
Quality of Life
Time frame: monthly (up to 18 months)
Health economic analysis
Time frame: recorded monthly (up to 18 months)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey R Yachnin, MD, PhD study director
Uppsala University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Electrochemotherapy in people with Breast Cancer and Skin Metastases, run by Uppsala University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
local control of skin metastases (time frame: 6 months from randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2014.