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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00402519
• Other study ID #: GEC-ESTRO APBI Trial
• Status: Active, not recruiting
• Phase: Phase 3
• First received: November 21, 2006
• Last updated: May 12, 2016
• Start date: November 2004
• Est. completion date: November 2019

Study information

• Verified date: May 2016
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1300
• Est. completion date: November 2019
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Radiation:
• Accelerated partial breast irradiation
APBI with PDR and HDR brachytherapy
• External beam whole breast irradiation
Standard Whole breast irradiation

Locations

Country	Name	City	State
Austria	University Hospital AKH Wien, Department of Radiotherapy and Radiobiology	Vienna
Germany	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	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
Hungary	National Institute of Oncology, Department of Radiation Oncology	Budapest
Poland	Kierownik Zakladu Brachyterapii, Cetrum Onkologii	Warszawa
Spain	Catalan Institut of Oncology, Department of Radiation Oncology	Barcelona
Spain	Valencian Institut of Oncology, Department of Radiation Oncology	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Countries where clinical trial is conducted

Austria,  Germany,  Hungary,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local control		5-years, 10 ten-years	No
Secondary	Incidence and severity of acute and late side effects		5-years	No
Secondary	Differences in cosmetic results		5-years	No
Secondary	Distant metastases free survival		5-years	No
Secondary	Survival rates (Overall Survival, Disease-free Survival)		5-years	No
Secondary	Contralateral breast cancer rate		5-years	No
Secondary	Quality-of-Life		5-years	No

External Links

•   Trial Homepage with a short version of the protocol