What is this study on ultrahypofractionated radiotherapy studying for breast cancer?

This study is evaluating whether a shorter, more intense radiotherapy schedule is not worse than the current standard treatment for breast cancer patients with unfavorable tumor features or younger age. Researchers aim to understand how these two radiation approaches compare in controlling the cancer and side effects. The trial is sponsored by IRCCS San Raffaele.

Who may be eligible for this breast cancer clinical trial?

Women aged 18 to 70 years with a diagnosis of breast cancer who have had breast-conserving surgery may be eligible. The study focuses on younger patients under 40 or those with specific aggressive tumor types. Participants should not have distant metastases or prior chest radiation. Please review eligibility criteria for more details.

Is there any cost to participate in this breast cancer clinical trial?

Study-related care, including the radiotherapy and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or related costs.

Actively Recruiting

Phase Not Applicable

Age: 18Years - 70Years

FEMALE

ID07020780

Five Fractions Ultrahypofractionated Whole Breast Radiotherapy and Simultaneous Integrated Boost to the Tumor Bed for Breast Cancer Patients With Unfavorable Characteristics

Led by IRCCS San Raffaele · Updated on 2025-07-28

458

Participants Needed

Research Sites

313 weeks

Total Duration

AI-Summary

What this Trial Is About

This research aims to compare two radiotherapy approaches for women with breast cancer who are either under 40 years old or have unfavorable tumor types such as lobular carcinoma, certain aggressive subtypes, or triple negative breast cancer. The study focuses on patients with clinical stage T1-T3 and lymph node involvement Nx-N3 after breast-conserving surgery, evaluating whether a shorter, more intense treatment schedule is not worse than the current standard treatment. The trial is prospective, randomized, and designed to assess non-inferiority between these treatments. Participants will receive one of two radiation therapy regimens. One group experimental arm will have whole breast irradiation totaling 26 Gy delivered in 5 fractions, with a simultaneous integrated boost SIB to the tumor bed totaling 30 Gy. The other group standard arm will receive whole breast irradiation totaling 40.05 Gy in 15 fractions, with SIB to 48 Gy. Intensity modulated radiotherapy IMRT plans will be used to optimize coverage and protect organs at risk. Both treatments are given after surgery and may include lymph node areas. During the study, participants will be monitored for local relapse-free survival over 5 years, along with various toxicity assessments at 1 month, 3 months, and up to 5 years. Other outcomes include local control, breast tumor recurrence, regional relapse-free survival, distant metastasis-free survival, disease-free survival, breast cancer-specific survival, overall survival, and cosmetic results. Additional evaluations will assess treatment-emergent adverse events, organ movement, radiomics, and predictive factors for toxicity and disease progression. The study will run through June 2035.

CONDITIONS

Brief Title

5 fr Ultrahypofractionated WBI and SIB for Breast Cancer With Unfavorable Characteristics

Who Can Participate

Age: 18Years - 70Years

FEMALE

Eligibility Criteria

You may qualify if you...

Histological diagnosis of breast cancer
Patients younger than 40 years regardless of tumor subtype, or aged 40 to 70 years with lobular carcinoma, Luminal B Her2 positive, hormone receptor negative Her2 positive, or triple negative breast cancer
Signed informed consent
Clinical stage T1-T3, Nx-N3
Negative surgical margins of at least 0.2 cm
No distant metastases (clinical M0) within the last 3 months
Performance status (ECOG) of 2 or less
No previous thoracic radiotherapy
Fertile women using contraceptive methods started during cancer treatment

You will not qualify if you...

Patients with favorable tumor characteristics (Luminal A, Luminal B Her2 negative) aged 40 or older undergoing partial breast irradiation
Patients who have had a mastectomy
Multicentric tumors
Positive or close surgical margins less than 0.2 cm
Known BRCA1/2 positive status
Serious systemic diseases
Mental or other disorders preventing informed consent
Previous invasive tumors except certain skin cancers unless disease-free for at least 3 years
Collagen or autoimmune diseases like lupus, rheumatoid arthritis, scleroderma, Sjogren's syndrome
Evidence of distant metastases
Contraindications to systemic treatment
Pregnant women
Non-compliance with established treatment dose limits

Research Team

Andrei Fodor, MD

Roberta Tummineri, MD

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