Dose Optimization for Pulsed-dose-rate (PDR)/High-dose-rate (HDR) Brachytherapy Alone for Early Breast Cancer

Phase 2

• Conditions: Breast Cancer
• Interventions: Radiation: Interstitial multicatheter brachytherapy

• Registration Number: NCT01175694
• Lead Sponsor: University Hospital Erlangen

Brief Summary

Accelerated partial breast irradiation (APBI) leads to a equivalent local control rate with lower toxicity as external beam irradiation (EBI) after breast conserving surgery (BCS) in a highly selected subgroup of patients with low risk invasive carcinoma and low risk duct carcinoma in-situ (DCIS). The goal of this trial is to assess the role of a modified dose of pulsed-dose-rate (PDR) and high-dose-rate (HDR) brachytherapy alone as Accelerated Partial Breast Irradiation (APBI) in a defined low-risk group of invasive breast cancer or ductal carcinoma in situ concerning local failure (all ipsilateral local recurrences), in particular regarding the local recurrences, the toxicity and for the cosmetic result. It is a phase II study. According to study protocol altogether 200 female patients will be treated.

Detailed Description

Focus of this trial is to assess the role a modified dose of PDR- and HDR-brachytherapy as Accelerated Partial Breast Irradiation (APBI) alone in a defined low-risk group of invasive breast cancer or ductal carcinoma in situ concerning local failure(all ipsilateral local recurrences, in particular regarding the local recurrences, the toxicity and for the cosmetic result.

Study Timeline

• Study Start: 2010-01
• Status Verified: 2010-06
• Study First Submitted: 2010-08-04
• Study First Submitted QC: 2010-08-04
• Study First Posted: 2010-08-05
• Last Update Submitted: 2010-08-19
• Last Update Posted: 2010-08-20
• Primary Completion: 2012-06
• Study Completion: 2015-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

Not provided

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 International Federation of Gynecology and Obstetrics (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 telangiectatic or similar.
• Psychiatric disorders.
• Patient with breast deemed technically unsatisfactory for brachytherapy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Brachytherapy	Interstitial multicatheter brachytherapy	Interstitial multicatheter brachytherapy

Primary Outcome Measures

Name	Time	Method
local control rates	five years

Secondary Outcome Measures

Name	Time	Method
late side effects	5 years	to assess the incidence and severity of acute and late side effects of brachytherapy

Trial Locations

Locations (1)

Dept. of Radiation Oncology, University Hospital Erlangen; 🇩🇪 Erlangen, Germany