Overview
The purpose of this trial is to investigate the toxicities and efficacy of hypofractionated regional nodal radiotherapy (RNI) for one week in breast cancer patients treated with mastectomy or breast conserving surgery. Hypofractionated radiotherapy will be delivered to chest wall or whole breast and regional lymph regions (including supraclavicular/infraclavicular region, internal mammary nodes, and any part of the axillary bed at risk). Eligible breast cancer patients will be followed for at least 1 years to evaluate the acute and late radiation-induced toxicities, locoregional recurrence, over survival, distant metastasis, and quality of life.
Description
Eligible breast cancer patients will receive hypofractionated radiotherapy of 5.2 Gy in 5 fractions within one week and a sequential tumor bed boost of 5.2 Gy in 2 fractions to the conserved breast. The dose is prescribed to ipsilateral chest wall or whole breast and regional lymph regions (including supraclavicular/infraclavicular region, internal mammary nodes, and any part of the axillary bed at risk). All patients are treated with intensity modulated radiation therapy (IMRT) technique. The primary endpoint is ≥2 grade any acute radiation induced toxicity event. patients will be followed for at least 1 years to evaluate the acute and late radiation-induced toxicity, locoregional recurrence, over survival, distant metastasis, and quality of life.
Calculation of the required number of cases based on an alpha of 0.05 and a power of 80% with a maximal tolerable toxicity difference of 10% during and within 6 months after RNI comparing to conventional radiotherapy and lost rate of follow up of 10%. In total 197 patients are needed to be recruited.
Eligibility
Inclusion Criteria:
- Aged >18 years old
- Underwent radical surgery with either mastectomy or breast conserving surgery and axillary lymph node dissection (ALND)
- Ipsilateral clinically diagnosed and histologically confirmed invasive breast cancer T1-3
- >=1 pathologically positive axillary lymph nodes
- Karnofsky Performance Status scoring ≥80, and anticipative overall survival >5 years
- Surgery wound healed without infection
- Negative pathologically surgical margin
- ER (estrogen-receptor), PR (progesterone-receptor), HER2 (human epidermal growth factor receptor 2) and Ki67 testing can be performed on the primary breast tumor
- Women of child-bearing potential must agree to use adequate contraception for up to 1 month before study treatment and the duration of study participation
- Ability to understand and willingness to participate the research and sign the consent forms
Exclusion Criteria:
- Pathologically positive ipsilateral supraclavicular lymph node
- Pathologically or radiologically confirmed involvement of ipsilateral internal mammary lymph nodes
- Pregnant or lactating women
- Severe non-neoplastic medical comorbidities
- History of non-breast malignancy within 5 years with the exception of lobular carcinoma in situ, basal cell carcinoma of the skin, carcinoma in situ of skin, Adenocarcinoma in situ of the lung and carcinoma in situ of the cervix
- simultaneous contralateral breast cancer
- Previous radiotherapy to the neck, chest and/or ipsilateral axillary region
- Active collagen vascular disease
- Definitive pathological or radiologic evidence of distant metastatic disease
- Primary T4 tumor
- Interval between radical surgery (mastectomy or breast conserving surgery) and radiotherapy was more than 12 weeks or interval between last dose of adjuvant chemotherapy and radiotherapy was more than 8 weeks