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

Tracking Information
First Submitted Date ICMJE	November 21, 2006
First Posted Date ICMJE	November 22, 2006
Last Update Posted Date	May 13, 2016
Study Start Date ICMJE	November 2004
Actual Primary Completion Date	November 2009 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: February 18, 2010)	Local control [ Time Frame: 5-years, 10 ten-years ]
Original Primary Outcome Measures ICMJE; (submitted: November 21, 2006)	Local control
Change History	Complete list of historical versions of study NCT00402519 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: February 18, 2010)	Incidence and severity of acute and late side effects [ Time Frame: 5-years ]; Differences in cosmetic results [ Time Frame: 5-years ]; Distant metastases free survival [ Time Frame: 5-years ]; Survival rates (Overall Survival, Disease-free Survival) [ Time Frame: 5-years ]; Contralateral breast cancer rate [ Time Frame: 5-years ]; Quality-of-Life [ Time Frame: 5-years ]
Original Secondary Outcome Measures ICMJE; (submitted: November 21, 2006)	Incidence and severity of acute and late side effects; Differences in cosmetic results; Distant metastases free survival; Survival rates (Overall Survival, Disease-free Survival); Contralateral breast cancer rate; Quality-of-Life
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	APBI Versus EBRT Therapy After Breast Conserving Surgery for Low-risk Breast Cancer
Official Title ICMJE	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
Brief 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.
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.
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Breast Cancer
Intervention ICMJE	Radiation: Accelerated partial breast irradiation APBI with PDR and HDR brachytherapy; Radiation: External beam whole breast irradiation Standard Whole breast irradiation
Study Arms	Experimental: APBI Accelerated Partial Breast Irradiation with multicatheter brachytherapy Intervention: Radiation: Accelerated partial breast irradiation; Active Comparator: EBRT Standard External Beam Whole Breast Irradiation Intervention: Radiation: External beam whole breast irradiation
Publications *	Polgár C, Ott OJ, Hildebrandt G, Kauer-Dorner D, Knauerhase H, Major T, Lyczek J, Guinot JL, Dunst J, Miguelez CG, Slampa P, Allgäuer M, Lössl K, Polat B, Kovács G, Fischedick AR, Fietkau R, Resch A, Kulik A, Arribas L, Niehoff P, Guedea F, Schlamann A, Pötter R, Gall C, Uter W, Strnad V; Groupe Européen de Curiethérapie 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.; Ott OJ, Strnad V, Hildebrandt G, Kauer-Dorner D, Knauerhase H, Major T, Łyczek J, Guinot JL, Dunst J, Miguelez CG, Slampa P, Allgäuer M, Lössl K, Polat B, Kovács G, Fischedick AR, Wendt TG, Fietkau R, Kortmann RD, Resch A, Kulik A, Arribas L, Niehoff P, Guedea F, Schlamann A, Pötter R, Gall C, Malzer M, Uter W, Polgár C; Groupe Européen de Curiethérapie 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.; Strnad V, Ott OJ, Hildebrandt G, Kauer-Dorner D, Knauerhase H, Major T, Lyczek J, Guinot JL, Dunst J, Gutierrez Miguelez C, Slampa P, Allgäuer M, Lössl K, Polat B, Kovács G, Fischedick AR, Wendt TG, Fietkau R, Hindemith M, Resch A, Kulik A, Arribas L, Niehoff P, Guedea F, Schlamann A, Pötter R, Gall C, Malzer M, Uter W, Polgár C; Groupe Européen de Curiethérapie 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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Active, not recruiting
Actual Enrollment ICMJE; (submitted: February 18, 2010)	1300
Original Enrollment ICMJE; (submitted: November 21, 2006)	1170
Estimated Study Completion Date	November 2019
Actual Primary Completion Date	November 2009 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: 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.; 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. Exclusion Criteria: 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.; 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.
Sex/Gender	Sexes Eligible for Study: Female
Ages	40 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Austria, Germany, Hungary, Poland, Spain
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00402519
Other Study ID Numbers ICMJE	GEC-ESTRO APBI Trial
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Plan to Share IPD: Undecided
Responsible Party	University of Erlangen-Nürnberg Medical School
Study Sponsor ICMJE	University of Erlangen-Nürnberg Medical School
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Chair: Vratislav Strnad, MD University Hospital Erlangen, Germany Study Chair: Csaba Polgár, MD National Institute of Oncology Budapest, Hungary Study Director: Oliver J Ott, MD University Hospital Erlangen, Germany
PRS Account	University of Erlangen-Nürnberg Medical School
Verification Date	May 2016
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP