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

• ClinicalTrials.gov Identifier: NCT00402519
• Recruitment Status: Unknown
• First Posted: November 22, 2006
• Last Update Posted: May 13, 2016
• Sponsor: University of Erlangen-Nürnberg Medical School
• Information provided by (Responsible Party): University of Erlangen-Nürnberg Medical School

Tracking Information

• First Submitted Date: November 21, 2006
• First Posted Date: November 22, 2006
• Last Update Posted Date: May 13, 2016
• Study Start Date: November 2004
• Actual Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 18, 2010): Local control [ Time Frame: 5-years, 10 ten-years ]
• Original Primary Outcome Measures (submitted: November 21, 2006): Local control

Current Secondary Outcome Measures (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 (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 Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: APBI Versus EBRT Therapy After Breast Conserving Surgery for Low-risk Breast Cancer
• 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
• 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Breast Cancer

Intervention

• 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 *

• 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.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Unknown status
• Actual Enrollment (submitted: February 18, 2010): 1300
• Original Enrollment (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

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, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Austria, Germany, Hungary, Poland, Spain

Administrative Information

• NCT Number: NCT00402519
• Other Study ID Numbers: GEC-ESTRO APBI Trial
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: University of Erlangen-Nürnberg Medical School
• Original Responsible Party: Not Provided
• Current Study Sponsor: University of Erlangen-Nürnberg Medical School
• Original Study Sponsor: University of Erlangen-Nürnberg
• Collaborators: Not Provided

Investigators

• 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