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

Phase 3

• Conditions: Breast Cancer
• Interventions: Radiation: Accelerated partial breast irradiation; Radiation: External beam whole breast irradiation

• Registration Number: NCT00402519
• Lead Sponsor: University of Erlangen-Nürnberg Medical School

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 Timeline

• Study Start: 2004-11
• Study First Submitted: 2006-11-21
• Study First Submitted QC: 2006-11-21
• Study First Posted: 2006-11-22
• Primary Completion: 2009-11
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-12
• Last Update Posted: 2016-05-13
• Study Completion: 2019-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
APBI	Accelerated partial breast irradiation	Accelerated Partial Breast Irradiation with multicatheter brachytherapy
EBRT	External beam whole breast irradiation	Standard External Beam Whole Breast Irradiation

Primary Outcome Measures

Name	Time	Method
Local control	5-years, 10 ten-years

Secondary Outcome Measures

Name	Time	Method
Incidence and severity of acute and late side effects	5-years
Distant metastases free survival	5-years
Survival rates (Overall Survival, Disease-free Survival)	5-years
Differences in cosmetic results	5-years
Contralateral breast cancer rate	5-years
Quality-of-Life	5-years

Trial Locations

Locations (11)

University Hospital AKH Wien, Department of Radiotherapy and Radiobiology; 🇦🇹 Vienna, Austria

University Hospital Erlangen, Department of Radiation Oncology; 🇩🇪 Erlangen, Germany

University Hospital Kiel, Department of Radiation Oncology; 🇩🇪 Kiel, Germany

University Hospital Leipzig, Department of Radiation Oncology; 🇩🇪 Leipzig, Germany

Hospital Barmherzige Brüder, Department of Radiation Oncology; 🇩🇪 Regensburg, Germany

National Institute of Oncology, Department of Radiation Oncology; 🇭🇺 Budapest, Hungary

University Hospital Lübeck, Department of Radiation Oncology; 🇩🇪 Lübeck, Germany

Catalan Institut of Oncology, Department of Radiation Oncology; 🇪🇸 Barcelona, Spain

Kierownik Zakladu Brachyterapii, Cetrum Onkologii; 🇵🇱 Warszawa, Poland

Valencian Institut of Oncology, Department of Radiation Oncology; 🇪🇸 Valencia, Spain

University Hospital Rostock, Department of Radiation Oncology; 🇩🇪 Rostock, Germany