Breast Neoplasms
Conditions
Keywords
breast cancer, brachytherapy
Brief summary
To investigate clinical outcomes, late side effects, and cosmetic results of a single-fraction very accelerated partial breast irradiation as postoperative local treatment for the treatment of early stage breast cancer.
Detailed description
Accelerated Partial Breast Irradiation (APBI) has demonstrated the non-inferiority compared to external beam radiotherapy (EBRT) in the conserving-treatment of early breast carcinoma by using high-dose-rate (HDR) multicatheter interstitial brachytherapy (MIBT). The standard treatment regimen is 7-8 sessions with two treatments per day, for a total treatment time of 4-5 days. Based on 5-year results of the Groupe Européen de Curiethérapie European SocieTy for Radiotherapy & Oncology (GEC-ESTRO) Very Accelerated Partial Breast Irradiation (VAPBI) phase I-II trial, in low-risk cases, 3-4 fractions delivered in 2 days reduced the overall treatment time with low rate of side effects and excellent oncological outcome. Retrospective and prospective studies with a single fraction HDR MIBT-based VAPBI suggest that by further increasing the dose delivered in one fraction, the total treatment time can be reduced to a single session safely. A phase II multicenter trial is proposed to confirm this hypothesis.
Interventions
RADIATIONsingle-fraction very accelerated partial breast irradiation
Adjuvant accelerated partial breast brachytherapy, with interstitial multicatheter technique, in one fraction.
Sponsors
National Institute of Oncology, Hungary
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Stage 0 \& I \& II (\< 3 cm) breast carcinoma * Lesions of \< 3 cm diameter * Invasive carcinoma of any subtype and grade or ductal carcinoma in situ (DCIS) * Nodal status: node-negative (pN0) or micro-metastatic (pN1mi) (patients with pN1mi status can be treated, but due to the limited clinical evidence, individual decision is needed) * M0: Absence of distant metastasis * Clear resection margins by National Surgical Adjuvant Breast and Bowel Project (NSABP) definition (no tumor on ink) * Unifocal (multifocality limited within 2 cm) and unicentric breast cancer * Age\> 40 years * Luminal A or B tumors * Time interval from surgery preferably less than 12 weeks and no longer than 20 weeks, and from adjuvant chemotherapy less than 4 weeks * Human Epidermal growth factor Receptor 2 positive (HER2+) patients receiving postoperative anti-HER2 systemic therapy * Specific signed consent form prior to randomization
Exclusion criteria
* Stage III-IV breast cancer * Surgical margins that cannot be microscopically assessed * Extensive intraductal component (EIC+) * Extensive lymphovascular invasion (LVI+) (focal is allowed) * Triple negative breast cancer * BReast CAncer gene (BRCA) 1-2 mutation * Human Epidermal growth factor Receptor 2 positive (HER2+) patients not receiving postoperative anti-HER2 systemic therapy * Neoadjuvant systemic therapy * Paget's disease or pathological skin involvement * Synchronous or previous breast cancer. * Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Five-year incidence of late grade ≥ 2 side effects | From the third month of treatment to the end of the fifth year of follow-up. | Radiation side effects based on Common Terminology Criteria for Adverse Events (CTCAE) (grade 1 to grade 5, higher score worse); and with the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/EORTC) Late Radiation Morbidity Scoring Schema (grade 1 to grade 4, higher score worse). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence (5-year actuarial rate) of ipsilateral breast recurrence (IBR) | From treatment to the end of the fifth year of follow-up. | — |
| Incidence (5-year actuarial rate) of regional relapse (RR) | From treatment to the end of the fifth year of follow-up. | — |
| Incidence (5-year actuarial rate) of contralateral breast cancer (CBC) | From treatment to the end of the fifth year of follow-up. | — |
| Incidence (5-year actuarial rate) of distant metastasis (DM) | From treatment to the end of the fifth year of follow-up. | — |
| Incidence (5-year actuarial rate) of any relapse (local, regional or distant, whichever came first) for disease free survival (DFS) | From treatment to the end of the fifth year of follow-up. | — |
| Incidence (5-year actuarial rate) of breast cancer death for cause specific survival (CSS) | From treatment to the end of the fifth year of follow-up. | — |
| Incidence (5-year actuarial rate) of death by any cause for overall survival (OS) | From treatment to the end of the fifth year of follow-up. | — |
| Incidence of acute side effects | From treatment to the end of the first 3 months of follow-up. | Radiation side effects based on Common Terminology Criteria for Adverse Events (CTCAE) (grade 1 to grade 5, higher score worse); and with the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/EORTC) Late Radiation Morbidity Scoring Schema (grade 1 to grade 4, higher score worse). |
| Cosmetic results at 5 years | From treatment to the end of the fifth year of follow-up. | Cosmetic results based on the Harvard criteria (excellent, good, fair, poor). |
| Quality of Life (QoL) | From treatment to the end of the fifth year of follow-up. | European Organisation For Research And Treatment Of Cancer (EORTC) Quality of Life questionnaire (QLQ) C30 questionaire including the Breast cancer module (QLQ-BR23) (53 questions in total, from 1 to 4 points, higher score worse) |
Countries
France, Germany, Hungary, Lithuania, Poland, Portugal, Serbia, Spain, Switzerland
Contacts
CONTACTViktor Smanykó, MD
PRINCIPAL_INVESTIGATORViktor Smanykó, MD
National Institute of Oncology, Budapest, Hungary
Outcome results
None listed