Risk-Stratified Hypofractionated Radiotherapy After Breast-Conserving Surgery for Early Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Whole-breast irradiation and tumor bed boost, Partial-breast irradiation.
- Who it may be relevant to
- Registry conditions: Early Stage Breast Carcinoma, Breast Cancer. Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective Study of Risk-Stratified Hypofractionated Radiotherapy After Breast-Conserving Surgery for Early Breast Cancer
Overview
This prospective study is designed to evaluate the feasibility, efficacy, and safety of risk-stratified hypofractionated radiotherapy after breast-conserving surgery in patients with early breast cancer.
Detailed description
Eligible patients with early breast cancer who have undergone breast-conserving surgery will be stratified into a high-risk group or a low-risk group according to the presence or absence of predefined high-risk factors.
Patients in the high-risk group will receive whole-breast irradiation with a simultaneous integrated boost to the tumor bed. The prescribed dose will be 36 Gy in 15 fractions over 3 weeks to the whole breast and 48 Gy in 15 fractions over 3 weeks to the tumor bed.
Patients in the low-risk group will receive partial-breast irradiation. Two hypofractionated schedules may be used: 40.05 Gy in 15 fractions over 3 weeks or 26 Gy in 5 fractions over 1 week.
Patients will be followed during and after radiotherapy to evaluate treatment efficacy, recurrence rates, and acute and late radiation-related toxicities.
Interventions
- Radiation Whole-breast irradiation and tumor bed boost
Whole-breast irradiation: 36 Gy in 15 fractions; Tumor bed boost: 48 Gy in 15 fractions - Radiation Partial-breast irradiation
Partial-breast irradiation: 40.05 Gy in 15 fractions or 26 Gy in 5 fractions
Primary outcome measures
- Local recurrence rate [Time frame: Five years]
Secondary outcome measures (2)
- Disease-free survival rate [Time frame: Five years]
- Radiation-related adverse events [Time frame: Five years]
Eligibility criteria
Inclusion criteria
- ECOG performance status score of 0 to 2.
- Pathologically confirmed breast cancer, including invasive carcinoma or ductal carcinoma in situ.
- Clinical stage cT0-2N0M0.
- Underwent breast-conserving surgery.
- Negative surgical margins greater than 2 mm.
Exclusion criteria
- Regional lymph node metastasis.
- Distant metastasis.
- Bilateral breast cancer.
- Prior thoracic radiotherapy.
- Life expectancy of less than 5 years.
- Lactating or pregnant women.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Factorial
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Cancer Hospital, Chinese Academy of Medical Sciences — Beijing
Identifiers
NCT: NCT07657442 · NCC25/095-0095