Phase 2 Study of Whole Breast Irradiation With Inversely Intensity Modulated Radiotherapy and Simultaneously Integrated Boost for Early Stage Breast Cancer Patients
- Eastern Cooperative Oncology Group performance score﹤2
- All patients aged >18 years and < 70 years after breast conserving surgery.
- On histological examination, the tumor must be DCIS or invasive adenocarcinoma of the
- Negative nodal status determined by sentinel node biopsy, or axillary dissection.
Axillary staging is not required for patients with DCIS
- No evidence of distant metastasis
- Gross disease may be unifocal or multifocal with pathologic (invasive and/or DCIS)
tumor size excised with negative margins（＞2mm）
- Surgical treatment of the breast must have been lumpectomy. Re-excision of surgical
margins is permitted.
- The patient must consent to be in the study and must have signed an approved consent
- Eastern Cooperative Oncology Group performance score≧2
- Presence of extensive intraductal component (ductal carcinoma in situ occupying > 25%
of the primary invasive tumour and present adjacent to the primary tumour).Suspicious
microcalcifications, densities, or palpable abnormalities (in the ipsilateral or
contralateral breast) unless biopsied and found to be benign.
- Proven multicentric carcinoma (invasive cancer or DCIS) in more than one quadrant of
- Metastatic disease (M1)
- Pregnancy or lactating
- Surgical margins that cannot be microscopically assessed or are positive at
- Psychiatric or addictive disorders that preclude obtaining informed consent or
adherence to protocol.
- Collagen vascular disease, specifically dermatomyositis with a CPK level above normal
or with an active skin rash, systemic lupus erythematosis, or scleroderma.
- Prior breast or thoracic RT for any condition.
- Previous or concomitant malignancies except non-melanoma skin cancer, carcinoma in
situ of the cervix, and invasive carcinoma of the colon, thyroid, cervix, or
endometrium treated five years prior to study entry.
- Synchronous chemotherapy or target therapy is not permitted.
- Refusal of the patients to be included in the study