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

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ClinicalTrials.gov Identifier: NCT00402519
Recruitment Status : Unknown
Verified May 2016 by University of Erlangen-Nürnberg Medical School.
Recruitment status was:  Active, not recruiting
First Posted : November 22, 2006
Last Update Posted : May 13, 2016
Sponsor:
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breast Cancer Radiation: Accelerated partial breast irradiation Radiation: External beam whole breast irradiation Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : November 2004
Actual Primary Completion Date : November 2009
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: APBI
Accelerated Partial Breast Irradiation with multicatheter brachytherapy
 Radiation: Accelerated partial breast irradiation
APBI with PDR and HDR brachytherapy
Active Comparator: EBRT
Standard External Beam Whole Breast Irradiation
 Radiation: External beam whole breast irradiation
Standard Whole breast irradiation


Outcome Measures
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Primary Outcome Measures :
  1. Local control [ Time Frame: 5-years, 10 ten-years ]

Secondary Outcome Measures :
  1. Incidence and severity of acute and late side effects [ Time Frame: 5-years ]
  2. Differences in cosmetic results [ Time Frame: 5-years ]
  3. Distant metastases free survival [ Time Frame: 5-years ]
  4. Survival rates (Overall Survival, Disease-free Survival) [ Time Frame: 5-years ]
  5. Contralateral breast cancer rate [ Time Frame: 5-years ]
  6. Quality-of-Life [ Time Frame: 5-years ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00402519


Locations
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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
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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
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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.

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Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT00402519    
Other Study ID Numbers: GEC-ESTRO APBI Trial
First Posted: November 22, 2006    Key Record Dates
Last Update Posted: May 13, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases