single-fraction very accelerated partial breast irradiation
single-fraction very accelerated partial breast irradiation: Adjuvant accelerated partial breast brachytherapy, with interstitial multicatheter technique, in one fraction.
Study 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.
Eligibility
Sex
FEMALE
Min age
40 Years
Max age
—
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
Primary outcome measure(s)
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).
Trial sites (23)
Facility
City
Region
Status
Centre Léon Bérard
Lyon
France
Not Yet Recruiting
Institut de Cancérologie de Lorraine
Nancy
France
Not Yet Recruiting
Antoine Lacassagne Cancer Centre
Nice
France
Recruiting
Klinikum Bremerhaven
Bremerhaven
Germany
Not Yet Recruiting
University Hospital Erlangen
Erlangen
Germany
Recruiting
Universitätsklinikum Schleswig-Holstein
Lübeck
Germany
Not Yet Recruiting
Sana Klinikum Offenbach
Offenbach
Germany
Not Yet Recruiting
Universitätsklinikum Würzburg
Würzburg
Germany
Not Yet Recruiting
National Institute of Oncology
Budapest
Hungary
Recruiting
National Cancer Institute
Vilnius
Lithuania
Not Yet Recruiting
Maria Skłodowska-Curie Bialystok Oncology Center
Bialystok
Poland
Not Yet Recruiting
Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny
Brzozów
Poland
Not Yet Recruiting
National Institute of Oncology
Gliwice
Poland
Recruiting
Greater Poland Cancer Centre
Poznan
Poland
Recruiting
Lower Silesian Oncology, Pulmonology and Hematology Center
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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