Breast Cancer, Early Stage Breast Carcinoma
Conditions
Keywords
breast cancer, radiotherapy
Brief summary
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
RADIATIONWhole-breast irradiation and tumor bed boost
Whole-breast irradiation: 36 Gy in 15 fractions; Tumor bed boost: 48 Gy in 15 fractions
RADIATIONPartial-breast irradiation
Partial-breast irradiation: 40.05 Gy in 15 fractions or 26 Gy in 5 fractions
Sponsors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local recurrence rate | Five years | Ipsilateral breast recurrence rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free survival rate | Five years | Disease-free survival rate |
| Radiation-related adverse events | Five years | Adverse events |
Countries
China
Contacts
CONTACTShu-Lian Wang, MD
Outcome results
None listed