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.

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