Breast Cancer, Breast Neoplasms
Conditions
Keywords
Breast cancer, simultaneous integrated boost, hypofractionated radiotherapy, whole breast radiotherapy
Brief summary
This is a prospective non randomized phase two trial evaluating the feasibility of a ten fraction accelerated hypofractionated radiotherapy schedule with simultaneous integrated boost risk adapted in patients undergoing breast conserving surgery for early breast cancer
Detailed description
Patients enrolled for the study, according to eligibility criteria, undergo breast conserving surgery followed by adjuvant 10-fraction whole breast irradiation with a risk adapted simultaneous-integrated boost dose at the level of the tumour bed according to clinical and pathological risk factors.
Interventions
RADIATIONTen-fraction hypofractionated breast radiotherapy with 40 Gy simultaneous integrated bed boost
Patients undergo BCS followed by ten-fraction adjuvant breast irradiation (34Gy) with a risk adapted SIB dose of 40 Gy
RADIATIONTen-fraction hypofractionated breast radiotherapy with 43 Gy simultaneous integrated bed boost
Patients undergo BCS followed by ten-fraction adjuvant breast irradiation (34Gy) with a risk adapted SIB dose of 43 Gy
Sponsors
Regina Elena Cancer Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Two test groups. Phase 2 study because of 2 test groups with 2 types of SIB. A Simultaneous integrated boost to 40 Gy (SIB 40): 34 Gy to the ipsilateral breast with concomitant boost to 40 Gy to the tumor bed. A Simultaneous integrated boost to 43 Gy (SIB 43): 34 Gy to the ipsilateral breast with concomitant boost to 43 Gy to the tumor bed
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Histologically proven invasive or in situ unifocal adenocarcinoma of the breast * Breast conserving surgery * Pathological pTis G3, pT1-2 any Grade, pN0 or pN0(sn) (isolated tumor cells \[i+\] allowed) pN1mic, M0 stage * Postoperative negative (no ink) final surgical margins * Patient requires a whole breast radiotherapy plus a tumor bed boost * Female patients aged ≥ 18 years of any menopausal status * ECOG performance status 0-2
Exclusion criteria
* Past history of malignancy except basal cell skin cancer and CIN cervix uteri or non-breast malignancy allowed if treated with curative intent and at least 5 years' disease free * Mastectomy * Concomitant chemotherapy (primary or sequential chemotherapy allowed) (Chemotherapy and radiotherapy must be separated by a minimum of 2 weeks). (Patients receiving neo-adjuvant chemotherapy are not excluded) * Known disorders associated with a higher risk for complications following radiotherapy such as collagen vascular disease, dermatomyositis, systemic lupus erythematosus or scleroderma * Any psychological, familiar, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule * Any serious uncontrolled medical disorder, non-malignant systemic disease, or active uncontrolled infection. Example include but are not limited to uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction or uncontrolled major seizure disorder * Pregnant or lactating patients * Presence of ipsilateral breast implant * Prior breast or thoracic radiotherapy for any condition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Late Effects Normal Tissue Task Force (LENT)-Subjective, Objective, Management, Analytic (SOMA) scale | From the end of treatment at 3 years | Incidence of grade 2-3 late toxicity in terms of skin toxicity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of local tumor relapse, distant metastasis and assessment of overall survival | Time from the date of the diagnosis of primary breast cancer to the date of diagnosis of local relapse, distant metastasis or death from any cause, assessed up to 60 months | Identification of local tumor relapse in the breast parenchyma within boost volume, breast parenchyma within volume receiving 34Gy; identification of distant metastasis and analysis of overall survival |
Countries
Italy
Outcome results
None listed