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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by University of Erlangen-Nürnberg Medical School.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:
NCT00402519
First received: November 21, 2006
Last updated: February 18, 2010
Last verified: February 2010

November 21, 2006
February 18, 2010
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.

Not Provided
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
    Intervention: Radiation: Accelerated partial breast irradiation
  • Active Comparator: EBRT
    Intervention: Radiation: External beam whole breast irradiation
Not Provided

*   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 2014
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
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Germany,   Hungary,   Poland,   Spain
 
NCT00402519
GEC-ESTRO APBI Trial
Not Provided
Dr. med. Bernd Gebhardt MBA, University of Erlangen-Nürnberg
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
February 2010

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