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Breast CancerPhase 3NCT00402519

APBI Versus EBRT Therapy After Breast Conserving Surgery for Low-risk Breast Cancer

A Phase 3 study testing Accelerated partial breast irradiation and External beam whole breast irradiation in people with Breast Cancer, run by University of Erlangen-Nürnberg Medical School at 11 sites in 5 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To assess the role of interstitial brachytherapy alone compared to whole breast irradiation in a defined low-risk group of invasive breast cancer or ductal carcinoma in situ concerning local failure (all ipsilateral local recurrences) to affirm the hypothesis that local control rates in each arm are equivalent. Read more about this study

Who is it for?
Ages 40 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Accelerated partial breast irradiation and External beam whole breast irradiation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,300 participants
Where
11 sitesin 5 countries
Study dates
Nov 2004to Nov 2019
Phase
Phase 3
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 40 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 confirmed.
  • pN0/pNmi (a minimum of 6 nodes in specimen, or a negative sentinel node is acceptable); in the case of DCIS alone axillary staging (e.g. sentinel lymph node biopsy) is optional.
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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 (Van Nuys Prognostic Index <8).
  • Unifocal and unicentric DCIS or breast cancer.
  • Age >= 40 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 prior to randomization.

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 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 telangiectatica or similar.
  • Psychiatric disorders.
  • Patient with breast deemed technically unsatisfactory for brachytherapy.

Trial locations and contacts

11 sites in 5 countries.

11 sites in 5 countries

Germany6 sites

  • University Hospital Erlangen, Department of Radiation Oncology

    Erlangen, 91054

  • University Hospital Kiel, Department of Radiation Oncology

    Kiel

  • University Hospital Leipzig, Department of Radiation Oncology

    Leipzig

  • University Hospital Lübeck, Department of Radiation Oncology

    Lübeck

  • Hospital Barmherzige Brüder, Department of Radiation Oncology

    Regensburg

  • University Hospital Rostock, Department of Radiation Oncology

    Rostock

Other trials in Germany

Spain2 sites

  • Catalan Institut of Oncology, Department of Radiation Oncology

    Barcelona, 08907

  • Valencian Institut of Oncology, Department of Radiation Oncology

    Valencia, 46009

Other trials in Spain

Austria1 site

  • University Hospital AKH Wien, Department of Radiotherapy and Radiobiology

    Vienna

Other trials in Austria

Hungary1 site

  • National Institute of Oncology, Department of Radiation Oncology

    Budapest

Other trials in Hungary

Poland1 site

  • Kierownik Zakladu Brachyterapii, Cetrum Onkologii

    Warsaw

Other trials in Poland

About this study

Official title: Interstitial Brachytherapy Alone Versus External Beam Radiation Therapy After Breast Conserving Surgery for Low-risk Invasive Carcinoma and Low-risk Ductal Carcinoma in Situ (DCIS) of the Female Breast

To assess the role of interstitial brachytherapy alone compared to whole breast irradiation in a defined low-risk group of invasive breast cancer or ductal carcinoma in situ concerning local failure (all ipsilateral local recurrences) to affirm the hypothesis that local control rates in each arm are equivalent.

Read the detailed description

To assess the role of interstitial brachytherapy alone compared to whole breast irradiation in a defined low-risk group of invasive breast cancer or ductal carcinoma in situ concerning local failure (all ipsilateral local recurrences) to affirm the hypothesis that local control rates in each arm are equivalent.

Conditions
Breast Cancer
Being tested
Accelerated partial breast irradiation, External beam whole breast irradiation
Keywords
accelerated partial breast irradiation, multicatheter brachytherapy, high dose rate brachytherapy, pulsed dose rate brachytherapy
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Accelerated partial breast irradiationRadiation

    APBI with PDR and HDR brachytherapy

  • External beam whole breast irradiationRadiation

    Standard Whole breast irradiation

Study groups in NCT00402519
Study groupRoleWhat they receive
APBIExperimentalAccelerated Partial Breast Irradiation with multicatheter brachytherapy
Receives: Radiation: Accelerated partial breast irradiation
EBRTActive comparatorStandard External Beam Whole Breast Irradiation
Receives: Radiation: External beam whole breast irradiation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Local control

    Measured: 5-years, 10 ten-years

Secondary outcomes (6)

  1. Incidence and severity of acute and late side effects

    Measured: 5-years

  2. Differences in cosmetic results

    Measured: 5-years

  3. Distant metastases free survival

    Measured: 5-years

  4. Survival rates (Overall Survival, Disease-free Survival)

    Measured: 5-years

  5. Contralateral breast cancer rate

    Measured: 5-years

  6. Quality-of-Life

    Measured: 5-years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2006 (estimated)
  2. Study startNov 2004
  3. Primary completionNov 2009
  4. Study completionNov 2019 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00402519
Sponsor's protocol ID
GEC-ESTRO APBI Trial
Status last verified
May 2016
First submitted
21 Nov 2006
Last updated
13 May 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Strnad V, Polgar C, Ott OJ, Hildebrandt G, Kauer-Dorner D, Knauerhase H, Major T, Lyczek J, Guinot JL, Gutierrez Miguelez C, Slampa P, Allgauer M, Lossl K, Polat B, Fietkau R, Schlamann A, Resch A, Kulik A, Arribas L, Niehoff P, Guedea F, Dunst J, Gall C, Uter W; Groupe Europeen de Curietherapie and European Society for Radiotherapy and Oncology. Accelerated partial breast irradiation using sole interstitial multicatheter brachytherapy compared with whole-breast irradiation with boost for early breast cancer: 10-year results of a GEC-ESTRO randomised, phase 3, non-inferiority trial. Lancet Oncol. 2023 Mar;24(3):262-272. doi: 10.1016/S1470-2045(23)00018-9. Epub 2023 Feb 1.

    PubMed 36738756

  • Schafer R, Strnad V, Polgar C, Uter W, Hildebrandt G, Ott OJ, Kauer-Dorner D, Knauerhase H, Major T, Lyczek J, Guinot JL, Dunst J, Miguelez CG, Slampa P, Allgauer M, Lossl K, Kovacs G, Fischedick AR, Fietkau R, Resch A, Kulik A, Arribas L, Niehoff P, Guedea F, Schlamann A, Gall C, Polat B; Groupe Europeen de Curietherapie of European Society for Radiotherapy and Oncology (GEC-ESTRO). Quality-of-life results for accelerated partial breast irradiation with interstitial brachytherapy versus whole-breast irradiation in early breast cancer after breast-conserving surgery (GEC-ESTRO): 5-year results of a randomised, phase 3 trial. Lancet Oncol. 2018 Jun;19(6):834-844. doi: 10.1016/S1470-2045(18)30195-5. Epub 2018 Apr 22.

    PubMed 29695348

  • Polgar C, Ott OJ, Hildebrandt G, Kauer-Dorner D, Knauerhase H, Major T, Lyczek J, Guinot JL, Dunst J, Miguelez CG, Slampa P, Allgauer M, Lossl K, Polat B, Kovacs G, Fischedick AR, Fietkau R, Resch A, Kulik A, Arribas L, Niehoff P, Guedea F, Schlamann A, Potter R, Gall C, Uter W, Strnad V; Groupe Europeen de Curietherapie of European Society for Radiotherapy and Oncology (GEC-ESTRO). Late side-effects and cosmetic results of accelerated partial breast irradiation with interstitial brachytherapy versus whole-breast irradiation after breast-conserving surgery for low-risk invasive and in-situ carcinoma of the female breast: 5-year results of a randomised, controlled, phase 3 trial. Lancet Oncol. 2017 Feb;18(2):259-268. doi: 10.1016/S1470-2045(17)30011-6. Epub 2017 Jan 14.

    PubMed 28094198

  • Ott OJ, Strnad V, Hildebrandt G, Kauer-Dorner D, Knauerhase H, Major T, Lyczek J, Guinot JL, Dunst J, Miguelez CG, Slampa P, Allgauer M, Lossl K, Polat B, Kovacs G, Fischedick AR, Wendt TG, Fietkau R, Kortmann RD, Resch A, Kulik A, Arribas L, Niehoff P, Guedea F, Schlamann A, Potter R, Gall C, Malzer M, Uter W, Polgar C; Groupe Europeen de Curietherapie of European Society for Radiotherapy and Oncology (GEC-ESTRO). GEC-ESTRO multicenter phase 3-trial: Accelerated partial breast irradiation with interstitial multicatheter brachytherapy versus external beam whole breast irradiation: Early toxicity and patient compliance. Radiother Oncol. 2016 Jul;120(1):119-23. doi: 10.1016/j.radonc.2016.06.019. Epub 2016 Jul 12.

    PubMed 27422584

  • Strnad V, Ott OJ, Hildebrandt G, Kauer-Dorner D, Knauerhase H, Major T, Lyczek J, Guinot JL, Dunst J, Gutierrez Miguelez C, Slampa P, Allgauer M, Lossl K, Polat B, Kovacs G, Fischedick AR, Wendt TG, Fietkau R, Hindemith M, Resch A, Kulik A, Arribas L, Niehoff P, Guedea F, Schlamann A, Potter R, Gall C, Malzer M, Uter W, Polgar C; Groupe Europeen de Curietherapie of European Society for Radiotherapy and Oncology (GEC-ESTRO). 5-year results of accelerated partial breast irradiation using sole interstitial multicatheter brachytherapy versus whole-breast irradiation with boost after breast-conserving surgery for low-risk invasive and in-situ carcinoma of the female breast: a randomised, phase 3, non-inferiority trial. Lancet. 2016 Jan 16;387(10015):229-38. doi: 10.1016/S0140-6736(15)00471-7. Epub 2015 Oct 19.

    PubMed 26494415

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Accelerated partial breast irradiation and External beam whole breast irradiation in people with Breast Cancer, run by University of Erlangen-Nürnberg Medical School at 11 sites in 5 countries.

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 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Germany, Spain, Austria, Hungary, Poland. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

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 (time frame: 5-years, 10 ten-years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00402519, which also lists 5 linked publications.

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 13 May 2016; AzTrials last refreshed its copy on 31 Oct 2026.

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