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:
University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:
NCT00402519
First received: November 21, 2006
Last updated: February 18, 2010
Last verified: February 2010
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Radiation: Accelerated partial breast irradiation
Radiation: External beam whole breast irradiation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of Erlangen-Nürnberg Medical School:

Primary Outcome Measures:
  • Local control [ Time Frame: 5-years, 10 ten-years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1300
Study Start Date: November 2004
Estimated Study Completion Date: November 2014
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: APBI Radiation: Accelerated partial breast irradiation
APBI with PDR and HDR brachytherapy
Active Comparator: EBRT Radiation: External beam whole breast irradiation
Standard Whole breast irradiation

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00402519

Locations
Austria
University Hospital AKH Wien, Department of Radiotherapy and Radiobiology
Vienna, Austria
Germany
University Hospital Erlangen, Department of Radiation Oncology
Erlangen, Germany, 91054
University Hospital Kiel, Department of Radiation Oncology
Kiel, Germany
University Hospital Leipzig, Department of Radiation Oncology
Leipzig, Germany
University Hospital Lübeck, Department of Radiation Oncology
Lübeck, Germany
Hospital Barmherzige Brüder, Department of Radiation Oncology
Regensburg, Germany
University Hospital Rostock, Department of Radiation Oncology
Rostock, Germany
Hungary
National Institute of Oncology, Department of Radiation Oncology
Budapest, Hungary
Poland
Kierownik Zakladu Brachyterapii, Cetrum Onkologii
Warszawa, Poland
Spain
Catalan Institut of Oncology, Department of Radiation Oncology
Barcelona, Spain, 08907
Valencian Institut of Oncology, Department of Radiation Oncology
Valencia, Spain, 46009
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
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
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. med. Bernd Gebhardt MBA, University of Erlangen-Nürnberg
ClinicalTrials.gov Identifier: NCT00402519     History of Changes
Other Study ID Numbers: GEC-ESTRO APBI Trial
Study First Received: November 21, 2006
Last Updated: February 18, 2010
Health Authority: Germany: Ethics Commission

Keywords provided by University of Erlangen-Nürnberg Medical School:
accelerated partial breast irradiation
multicatheter brachytherapy
high dose rate brachytherapy
pulsed dose rate brachytherapy

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma, Intraductal, Noninfiltrating
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Ductal, Lobular, and Medullary

ClinicalTrials.gov processed this record on August 27, 2014