Five Fractions Ultrahypofractionated Whole Breast Radiotherapy and Simultaneous Integrated Boost to the Tumor Bed, for Breast Cancer Patients With Unfavorable Characteristics
Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This is a prospective, randomized, single-center, non-inferiority interventional clinical trial comparing whole breast irradiation (WBI) to a total dose of 26 Gy in 5 fractions with simultaneous integrated boost (SIB) to the tumor bed to a total dose of 30 Gy, and WBI to a total dose of 40.05 Gy in 15 fractions with SIB to the tumor bed to a total dose of 48 Gy (standard treatment), for young or unfavorable breast cancer patients.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• Histological diagnosis of breast cancer
• Patients younger than 40 years regardless of histological subtype, or patients between 40 and 70 years with lobular carcinoma, histological subtypes Luminal B Her2 positive, or with hormone receptors negative and Her2 positive (ErbB2), or triple negative (TNBC)
• Signed informed consent
• Clinical stage T1-T3, Nx-N3
• Negative surgical margins (≥ 0.2 cm)
• Clinical M0 in the previous 3 months
• PS (ECOG) ≤2
• No previous thoracic radiotherapy
• Fertile women using contraceptive methods started during oncological treatment
Locations
Other Locations
Italy
IRCCS San Raffaele Scientific Institute
RECRUITING
Milan
Contact Information
Primary
Andrei Fodor, MD
fodor.andrei@hsr.it
+390226437634
Backup
Roberta Tummineri, MD
tummineri.roberta@hsr.it
+390226435452
Time Frame
Start Date:2025-07-25
Estimated Completion Date:2035-06-30
Participants
Target number of participants:458
Treatments
Experimental: Arm 1- Five fractions radiotherapy
Patients in the study (randomized to arm 1) will be treated to the whole breast to a total dose (TD) of 26 Gy in 5 fractions, with simultaneous integrated boost (SIB) to a TD of 30 Gy to the tumor bed. For each patient, an IMRT (intensity modulated radiotherapy) treatment plan will be created to ensure adequate coverage of the treatment volumes and the tolerability of the Organs At Risk (OAR). Specific, already validated dose-volume constraints will be applied for the evaluation of OARs. The dose-volume histogram (DVH) for the Gross Tumor Volume (GTV), Clinical Target Volume (CTV), PTV, and OAR will be calculated in order to achieve the best optimization in terms of tolerability and efficacy.
Active_comparator: Arm 2- Fifteen fractions radiotherapy
Patients randomized to arm 2 will be treated according to the standard protocol of our department, delivering adjuvant whole breast irradiation (WBI) to a total dose (TD) of 40.05 Gy in 15 fractions, with simultaneous integrated boost (SIB) to the tumor bed to a TD of 48 Gy.