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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:
NCT00402519
First received: November 21, 2006
Last updated: May 12, 2016
Last verified: May 2016
History of Changes

November 21, 2006
May 12, 2016
November 2004
November 2009   (final data collection date for primary outcome measure)
Local control [ Time Frame: 5-years, 10 ten-years ] [ Designated as safety issue: No ]
Local control
Complete list of historical versions of study NCT00402519 on ClinicalTrials.gov Archive Site
  • Incidence and severity of acute and late side effects [ Time Frame: 5-years ] [ Designated as safety issue: No ]
  • Differences in cosmetic results [ Time Frame: 5-years ] [ Designated as safety issue: No ]
  • Distant metastases free survival [ Time Frame: 5-years ] [ Designated as safety issue: No ]
  • Survival rates (Overall Survival, Disease-free Survival) [ Time Frame: 5-years ] [ Designated as safety issue: No ]
  • Contralateral breast cancer rate [ Time Frame: 5-years ] [ Designated as safety issue: No ]
  • Quality-of-Life [ Time Frame: 5-years ] [ Designated as safety issue: No ]
  • 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
Not Provided
Not Provided
 
APBI Versus EBRT Therapy After Breast Conserving Surgery for Low-risk Breast Cancer
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.
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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Radiation: Accelerated partial breast irradiation
    APBI with PDR and HDR brachytherapy
  • Radiation: External beam whole breast irradiation
    Standard Whole breast irradiation
  • 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
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.
 
Active, not recruiting
1300
November 2019
November 2009   (final data collection date for primary outcome measure)

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.
Female
40 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Germany,   Hungary,   Poland,   Spain
 
NCT00402519
GEC-ESTRO APBI Trial
No
Undecided
Not Provided
University of Erlangen-Nürnberg Medical School
University of Erlangen-Nürnberg Medical School
Not Provided
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
University of Erlangen-Nürnberg Medical School
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP