Clinical trial NCT07021846: Dose Escalated Concomitant Boost Radiotherapy for Early Breast Cancer
Official title: Hypofractionated Radiotherapy With Dose Escalated Concomitant Boost for Breast Cancer: a Phase 2 Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: tumor bed boost
radiotherapy
hypofractionation
Lead sponsor: Fondazione Policlinico Universitario Campus Bio-Medico
Sponsor class: OTHER
First posted: 2025-06-15
Enrollment: 132
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this prospective, single-arm, phase II, non-randomized trial is to evaluate an hypofractionation schedule with high dose simultaneous integrated tumor bed boost in early breast cancer patients.

The main question\[s\] it aims to answer are:

* evaluate the rate of all grades of radiation-induced fibrosis at 4 years.
* evaluate poor/fair cosmesis rate Participants will be treated with hypofractionated radiotherapy (RT) to whole breast with a dose of 40.05 Gy in 15 fractions (2.67 Gy/die) and a concomitant tumor bed dose of 52.5 Gy (3.5 gy/die)

Detailed description: This is a prospective, single-arm, phase II, non-randomized clinical trial that will test an hypofractionated schedule with high dose simultaneous integrated tumor bed boost set on a previous dose finding study. Patients will be treated with hypofractionated RT to whole breast with a dose of 40.05 Gy in 15 fractions (2.67 Gy/die) and a concomitant tumor bed dose of 52.5 Gy (3.5 gy/die). The study population will include early breast cancer patients with younger age (\< or= 50 years) and additional risk factors for local recurrence.

The primary objective of the study is to evaluate the rate of radiation-induced fibrosis at 4 years.The expected enrollment is 132 patients in 6 years. Each patient must have a minimum follow-up of 4 years.

The secondary objective is to evaluate cosmesis; other objectives are to evaluate quality of life (QoL) and the rate of local control.

Eligibility criteria: Inclusion Criteria:

* histologically proven breast cancer who have undergone conservative surgery
* at least 3 inserted clips
* age: from 18 years old to 50 years
* at least one of the following risk factors: N1 disease, LVI, extensive intraductal component (\>25%), close margins (\<4 mm), non-hormone-sensitive disease, grading 3
* ECOG performance status \< 2
* adequate bone marrow (haemoglobin concentration \> 8 g/dl, white blood cell count \> 3000/mm3, platelet count \> 75000).

Exclusion Criteria:

* Previous chest radiation treatment
* Bilateral breast cancer
* Neoadjuvant chemotherapy
* BMI \> 35
* Collagen diseases
* Pregnancy or breastfeeding

Primary outcomes:
measure: Breast fibrosis
timeFrame: baseline, each year up to 4 years after radiotherapy
Secondary outcomes:
measure: Breast cosmesis
timeFrame: baseline, each year up to 4 years after radiotherapy
measure: Quality of Life (QOL)
timeFrame: baseline, each year up to 4 years after radiotherapy
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Università Campus Biomedico
Study officials:
References:
citation: Bartelink H, Horiot JC, Poortmans P, Struikmans H, Van den Bogaert W, Barillot I, Fourquet A, Borger J, Jager J, Hoogenraad W, Collette L, Pierart M; European Organization for Research and Treatment of Cancer Radiotherapy and Breast Cancer Groups. Recurrence rates after treatment of breast cancer with standard radiotherapy with or without additional radiation. N Engl J Med. 2001 Nov 8;345(19):1378-87. doi: 10.1056/NEJMoa010874.
citation: Romestaing P, Lehingue Y, Carrie C, Coquard R, Montbarbon X, Ardiet JM, Mamelle N, Gerard JP. Role of a 10-Gy boost in the conservative treatment of early breast cancer: results of a randomized clinical trial in Lyon, France. J Clin Oncol. 1997 Mar;15(3):963-8. doi: 10.1200/JCO.1997.15.3.963.
citation: Vrieling C, Collette L, Fourquet A, Hoogenraad WJ, Horiot JC, Jager JJ, Pierart M, Poortmans PM, Struikmans H, Van der Hulst M, Van der Schueren E, Bartelink H. The influence of the boost in breast-conserving therapy on cosmetic outcome in the EORTC "boost versus no boost" trial. EORTC Radiotherapy and Breast Cancer Cooperative Groups. European Organization for Research and Treatment of Cancer. Int J Radiat Oncol Biol Phys. 1999 Oct 1;45(3):677-85. doi: 10.1016/s0360-3016(99)00211-4.
citation: Yarnold J, Ashton A, Bliss J, Homewood J, Harper C, Hanson J, Haviland J, Bentzen S, Owen R. Fractionation sensitivity and dose response of late adverse effects in the breast after radiotherapy for early breast cancer: long-term results of a randomised trial. Radiother Oncol. 2005 Apr;75(1):9-17. doi: 10.1016/j.radonc.2005.01.005. Epub 2005 Mar 16.
citation: Ippolito E, Rinaldi CG, Silipigni S, Greco C, Fiore M, Sicilia A, Trodella L, D'Angelillo RM, Ramella S. Hypofractionated radiotherapy with concomitant boost for breast cancer: a dose escalation study. Br J Radiol. 2019 Mar;92(1095):20180169. doi: 10.1259/bjr.20180169. Epub 2018 Nov 28.