Dose Escalated Concomitant Boost Radiotherapy for Early Breast Cancer

NCT07021846 | Recruiting

• 1 other identifier: 63/19 PAR ComEt CBM
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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)

Conditions

Breast Cancer

Keywords

tumor bed boost; radiotherapy; hypofractionation

Outcome Measures

Primary Outcomes (1)

• Breast fibrosis

  Rate of all grades breast fibrosis evaluated by means of Common Terminology Criteria for Adverse Events (CTCAE) v. 5 scale

  baseline, each year up to 4 years after radiotherapy

Secondary Outcomes (2)

• Breast cosmesis

  baseline, each year up to 4 years after radiotherapy

• Quality of Life (QOL)

  baseline, each year up to 4 years after radiotherapy

Study Arms (1)

Hypofractionated arm + concomitant tumor bed boost

EXPERIMENTAL

Hypofractionation arm, 40 Gy in 15 fractions (2.67 Gy per fraction over 3 weeks) and a tumor bed boost to a total dose of 52.5 Gy in 15 fractions (3.5 Gy per fraction over 3 weeks).

Radiation: hypofractionated radiotherapy with tumor bed boost

Interventions

hypofractionated radiotherapy with tumor bed boost RADIATION

hypofractionated radiotherapy with concomitant/simultaneous tumor bed boost

Hypofractionated arm + concomitant tumor bed boost

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Campus Bio-Medico: lead

Study Sites (1)

Università Campus Biomedico

Roma, Italy

RECRUITING

Related Publications (5)

• 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.

  PMID: 11794170 BACKGROUND

• 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.

  PMID: 9060534 BACKGROUND

• 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.

  PMID: 10524422 BACKGROUND

• 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.

  PMID: 15878095 BACKGROUND

• 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.

  PMID: 30433824 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Edy Ippolito, Prof

CONTACT

+3906225418081; e.ippolito@unicampus.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: June 15, 2025
• Study Start: March 12, 2020
• Primary Completion: March 1, 2026
• Study Completion (Estimated): March 1, 2030
• Last Updated: June 15, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)