Breast CancerPhase 2NCT01175694
Dose Optimization for Pulsed-dose-rate (PDR)/High-dose-rate (HDR) Brachytherapy Alone for Early Breast Cancer
A Phase 2 study testing Interstitial multicatheter brachytherapy in people with Breast Cancer, run by University Hospital Erlangen at 1 site in Germany.
Trial summary
Accelerated partial breast irradiation (APBI) leads to a equivalent local control rate with lower toxicity as external beam irradiation (EBI) after breast conserving surgery (BCS) in a highly selected subgroup of patients with low risk invasive carcinoma and low risk duct carcinoma in-situ (DCIS). Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Interstitial multicatheter brachytherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2010to Jan 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 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage 0, I or II breast cancer.
- Invasive ductal, papillary, mucinous, tubular, medullary or lobular carcinoma.
- Ductal carcinoma in situ (DCIS) alone.
- No lymph invasion (L0) and no hemangiosis (V0).
- Lesions of < 3 cm diameter, histopathologically assured.
- pN0 (a minimum of 6 nodes in specimen, or a negative sentinel node is acceptable).
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- M0.
- Clear resection margins at least 2 mm in any direction; by lobular histology or DCIS histology only the resection margins must be clear at least 5 mm.
- For DCIS only: lesions must be classified as low or intermediate risk group
- Unifocal and unicentric DCIS or breast cancer.
- Age > 50 years.
- Time interval from final definitive breast surgical procedure to the start of external beam therapy or to brachytherapy is less than 12 weeks (84 days). If patients receive chemotherapy the radiotherapy can be started before systemic treatment (within 12 weeks). The radiation therapy can be also given in the interval between the chemotherapy courses. It is also possible to start radiation therapy after chemotherapy is completed according local protocols as soon as possible within 4 weeks after chemotherapy.
- Signed study-specific consent form
Who cannot join
- Stage III or IV breast cancer.
- Surgical margins that cannot be microscopically assessed.
- Extensive intraductal component (EIC).
- Paget's disease or pathological skin involvement.
- Synchronous or previous breast cancer.
- Prior malignancy (< 5 years prior to enrollment in study) except non-melanoma skin cancer or cervical carcinoma International Federation of Gynecology and Obstetrics (FIGO) 0 and I if patient is continuously disease-free.
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- Pregnant or lactating women.
- Collagen vascular disease.
- The presence of congenital diseases with increased radiation sensitivity, for example Ataxia telangiectatic or similar.
- Psychiatric disorders.
- Patient with breast deemed technically unsatisfactory for brachytherapy.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Dept. of Radiation Oncology, University Hospital Erlangen
Erlangen, 91054
Vratislav Strnad, MD, Prof., 49 9131 8544205, vratislav.strnad@uk-erlangen.de
Godehard Lahmer, MD
About this study
Official title: Phase II Study - Dose Optimization PDR/HDR Brachytherapy Alone for Early Breast Cancer
Accelerated partial breast irradiation (APBI) leads to a equivalent local control rate with lower toxicity as external beam irradiation (EBI) after breast conserving surgery (BCS) in a highly selected subgroup of patients with low risk invasive carcinoma and low risk duct carcinoma in-situ (DCIS). The goal of this trial is to assess the role of a modified dose of pulsed-dose-rate (PDR) and high-dose-rate (HDR) brachytherapy alone as Accelerated Partial Breast Irradiation (APBI) in a defined low-risk group of invasive breast cancer or ductal carcinoma in situ concerning local failure (all ipsilateral local recurrences), in particular regarding the local recurrences, the toxicity and for the cosmetic result. It is a phase II study. According to study protocol altogether 200 female patients will be treated.
Read the detailed description
Focus of this trial is to assess the role a modified dose of PDR- and HDR-brachytherapy as Accelerated Partial Breast Irradiation (APBI) alone in a defined low-risk group of invasive breast cancer or ductal carcinoma in situ concerning local failure(all ipsilateral local recurrences, in particular regarding the local recurrences, the toxicity and for the cosmetic result.
- Conditions
- Breast Cancer
- Being tested
- Interstitial multicatheter brachytherapy
- Keywords
- Brachytherapy, APBI, dose modification, local recurrences, side effects, cosmetic result
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interstitial multicatheter brachytherapyRadiation
Also called APBI
Interstitial PDR- and HDR-brachytherapy up to 50 Gy-eq
| Study group | Role | What they receive |
|---|---|---|
| Brachytherapy | Active comparator | Interstitial multicatheter brachytherapy Receives: Radiation: Interstitial multicatheter brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
local control rates
Measured: five years
Secondary outcomes (1)
late side effects
to assess the incidence and severity of acute and late side effects of brachytherapy
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2010 (estimated)
- Study startJan 2010
- Primary completionJun 2012 (estimated)
- Study completionJan 2015 (estimated)
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Erlangen
- Sponsor type
- University, hospital or other
- Investigators
- Vratislav Strnad, MD, Prof., Principal investigator, University Hospital Erlangen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01175694
- Sponsor's protocol ID
- Brachy-APBI-03
- Status last verified
- Jun 2010
- First submitted
- 4 Aug 2010
- Last updated
- 20 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study - Dose Optimization PDR/HDR Brachytherapy Alone for Early Breast Cancer
- ClinicalTrials.gov ID
- NCT01175694
- Acronym / sponsor ID
- Brachy-APBI-03
- Conditions
- Breast Cancer
- Keywords
- Brachytherapy, APBI, dose modification, local recurrences, side effects, cosmetic result
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital ErlangenUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 5 Aug 2010 (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.
Accelerated partial breast irradiation (APBI) leads to a equivalent local control rate with lower toxicity as external beam irradiation (EBI) after breast conserving surgery (BCS) in a highly selected subgroup of patients with low risk invasive carcinoma and low risk duct carcinoma in-situ (DCIS). The goal of this trial is to assess the role of a modified dose of pulsed-dose-rate (PDR) and high-dose-rate (HDR) brachytherapy alone as Accelerated Partial Breast Irradiation (APBI) in a defined low-risk group of invasive breast cancer or ductal carcinoma in situ concerning local failure (all ipsilateral local recurrences), in particular regarding the local recurrences, the toxicity and for the cosmetic result. It is a phase II study. According to study protocol altogether 200 female patients will be treated.
Detailed description
Focus of this trial is to assess the role a modified dose of PDR- and HDR-brachytherapy as Accelerated Partial Breast Irradiation (APBI) alone in a defined low-risk group of invasive breast cancer or ductal carcinoma in situ concerning local failure(all ipsilateral local recurrences, in particular regarding the local recurrences, the toxicity and for the cosmetic result.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brachytherapy | Active comparator | Radiation: Interstitial multicatheter brachytherapyInterstitial multicatheter brachytherapy |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Stage 0, I or II breast cancer.
- Invasive ductal, papillary, mucinous, tubular, medullary or lobular carcinoma.
- Ductal carcinoma in situ (DCIS) alone.
- No lymph invasion (L0) and no hemangiosis (V0).
- Lesions of < 3 cm diameter, histopathologically assured.
Key exclusion criteria (11 listed)
- Stage III or IV breast cancer.
- Surgical margins that cannot be microscopically assessed.
- Extensive intraductal component (EIC).
- Paget's disease or pathological skin involvement.
- Synchronous or previous breast cancer.
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 |
|---|---|---|
| Interstitial multicatheter brachytherapyAlso: APBIInterstitial PDR- and HDR-brachytherapy up to 50 Gy-eq | Radiation | Brachytherapy |
Primary outcome
local control rates
Time frame: five years
1 secondary outcome
late side effects
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2010.
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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.
Vratislav Strnad, MD, Prof. principal investigator
University Hospital Erlangen
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 Interstitial multicatheter brachytherapy in people with Breast Cancer, run by University Hospital Erlangen at 1 site in Germany.
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 13 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 20 Aug 2010. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vratislav Strnad, MD, Prof. (49 9131 8544205, vratislav.strnad@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
local control rates (time frame: five years). 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 20 Aug 2010.