The UK Standardisation of Breast Radiotherapy (START) Trial B of radiotherapy hypofractionation for treatment of early breast cancer: a randomised trial.
START Trialists' Group, S M Bentzen, R K Agrawal...
https://pubmed.ncbi.nlm.nih.gov/18355913Actively 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
1
Research Sites
313 weeks
Total Duration
On this page
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 5 fractions or 15 fractions over approximately 3 weeks
Participants receive adjuvant whole breast radiotherapy with a simultaneous integrated boost to the tumor bed. Depending on randomization, treatment consists of either 5 fractions over a short period or 15 fractions over a longer period.
5 or 15 visits (in-person) depending on treatment arm
Follow-up
Duration - Up to 5 years
Participants are monitored for acute and late toxicity, tumor control, survival outcomes, and quality of life for up to 5 years after treatment ends.
Periodic visits over 5 years
Trial Site Locations
Total: 1 location
1
IRCCS San Raffaele Scientific Institute
Milan, Italy, 20132
Actively Recruiting
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Research Team
A
Andrei Fodor, MD
R
Roberta Tummineri, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Randomized clinical trial of breast irradiation following lumpectomy and axillary dissection for node-negative breast cancer: an update. Ontario Clinical Oncology Group.
R M Clark, T Whelan, M Levine...
https://pubmed.ncbi.nlm.nih.gov/8931610Long-term results of hypofractionated radiation therapy for breast cancer.
Timothy J Whelan, Jean-Philippe Pignol, Mark N Levine...
https://pubmed.ncbi.nlm.nih.gov/20147717Three-Year Outcomes With Hypofractionated Versus Conventionally Fractionated Whole-Breast Irradiation: Results of a Randomized, Noninferiority Clinical Trial.
Simona F Shaitelman, Xiudong Lei, Alastair Thompson...
https://pubmed.ncbi.nlm.nih.gov/30379626Radiation doses and fractionation schedules in non-low-risk ductal carcinoma in situ in the breast (BIG 3-07/TROG 07.01): a randomised, factorial, multicentre, open-label, phase 3 study.
Boon H Chua, Emma K Link, Ian H Kunkler...
https://pubmed.ncbi.nlm.nih.gov/35934006European Society for Radiotherapy and Oncology Advisory Committee in Radiation Oncology Practice consensus recommendations on patient selection and dose and fractionation for external beam radiotherapy in early breast cancer.
Icro Meattini, Carlotta Becherini, Liesbeth Boersma...
https://pubmed.ncbi.nlm.nih.gov/34973228The use of moderately hypofractionated post-operative radiation therapy for breast cancer in clinical practice: A critical review.
Gustavo Nader Marta, Charlotte Coles, Orit Kaidar-Person...
https://pubmed.ncbi.nlm.nih.gov/33091800Hypofractionated versus conventional fractionated postmastectomy radiotherapy for patients with high-risk breast cancer: a randomised, non-inferiority, open-label, phase 3 trial.
Shu-Lian Wang, Hui Fang, Yong-Wen Song...
https://pubmed.ncbi.nlm.nih.gov/30711522Dose-escalated simultaneous integrated boost radiotherapy in early breast cancer (IMPORT HIGH): a multicentre, phase 3, non-inferiority, open-label, randomised controlled trial.
Charlotte E Coles, Joanne S Haviland, Anna M Kirby...
https://pubmed.ncbi.nlm.nih.gov/37302395Prolongation of overall treatment time as a cause of treatment failure in early breast cancer: An analysis of the UK START (Standardisation of Breast Radiotherapy) trials of radiotherapy fractionation.
Joanne S Haviland, Søren M Bentzen, Judith M Bliss...
https://pubmed.ncbi.nlm.nih.gov/27666929