hypofractionated radiation therapy with concomitant boost in treating women after breast conserving surgery

Conditions: Breast Cancer Female

Summary: this phase ii study is to evaluate the safety of hypofractionated whole breast radiation (hfrt) with simultaneous tumor bed boost(sib) in women with early breast cancer after breast-conserving surgery.

objectives: primary: to determine the toxicity with adjuvant hypofractionated whole breast radiation with simultaneous tumor bed boost (sib) in women with early breast cancer after breast conserving surgery. secondary: to determine the short term cosmetic and quality of life of the participants treated with this regimen. to determine the local control of the participants treated with this regimen. outline: patients undergo adjuvant hypofractionated whole breast radiation with simultaneous tumor bed boost once daily a week for 3 weeks. toxicity, quality of life and cosmetic result is assessed before radiation, at the end of the radiation, within 2, 4, 6 weeks after completion of radiotherapy, and then every 3 months for 1 ear. projected accrual: a total of 90 participants will be accrued for this study.

Eligibility criteria:
inclusion criteria: * female, aged between 18-70 * pathological confirmed breast invasive carcinoma * patients after breast lumpectomy(including quadrantectomy) with axillary lymph nodes dissection or sentinel node biopsy * stage p t 1-2 n 0 * metastasis omitted by routine examinations in 1 months before enrollment * complete blood count obtained in 2 weeks prior to study entry should meet the following criteria: absolute neutrophil count \> 1.8 \*10\^9/l, hemoglobin \> 8.0g/dl, platelet \> 75 \* 10\^9/l * hepatic and renal function in 2 weeks prior to study entry should be normal * study entry within 60 days from whichever comes later: surgery or last chemotherapy * women of childbearing potential must have a negative urine or serum pregnancy test with 2 weeks of study entry * signs study specific informed consent prior to study entry exclusion criteria: * breast cancer with stage iii/iii (ajcc 7th) * occult breast cancer * in-situ breast carcinoma * bilateral breast cancer * male breast cancer * breast lymphoma or breast sarcoma * combined with paget's disease * received preoperative treatment(including neoadjuvant chemotherapy, endocrine therapy and target therapy * positive surgical margin * axillary lymph nodes dissection or sentinel lymph node biopsy omitted * regional lymph nodes radiation needed * boost volume larger than 1/4 of the whole breast * tumor bed unable to recognize on ct * prior invasive malignant tumor history * prior radiation to thoracic * connective tissue disease, such as active systemic lupus erythematosus and scleroderma, etc. * severe, active co-morbidity, defined as follows: * unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months * severe, acute bacterial or fungal infection within the last 2 weeks * chronic obstructive pulmonary disease exacerbation or other respiratory illness within 30 days * pregnant women

Keywords: hypofractionated radiation breast cancer breast conserving surgery simultaneous boost radiation