Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments accelerated partial breast irradiation, external beam whole breast irradiation
Phase phase 3
Sponsor University of Erlangen-Nürnberg Medical School
Start date November 2004
End date November 2009
Trial size 1300 participants
Trial identifier NCT00402519, GEC-ESTRO APBI 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Accelerated Partial Breast Irradiation with multicatheter brachytherapy
accelerated partial breast irradiation
APBI with PDR and HDR brachytherapy
(Active Comparator)
Standard External Beam Whole Breast Irradiation
external beam whole breast irradiation
Standard Whole breast irradiation

Primary Outcomes

Measure
Local control
time frame: 5-years, 10 ten-years

Secondary Outcomes

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

Eligibility Criteria

Female participants at least 40 years old.

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.

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Erlangen-Nürnberg Medical School.