Breast Cancer
Conditions
Keywords
breast cancer, radiotherapy, simultaneous integrated boost, tumor bed, IMRT
Brief summary
This is a phase II study. In patients with node-negative invasive breast cancer or carcinoma in situ treated by breast conserving surgery, postoperative whole breast irradiation with inversely intensity modulated radiotherapy and a simultaneous integrated boost is technically feasible. The aim of this study is to evaluate the radiation toxicity, cosmetic outcome and local control rate in a single center
Interventions
IMRT in 25 fractions delivering 45Gy to the whole breast and 60Gy to the tumor bed
Sponsors
Fudan University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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 breast. * 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 form.
Exclusion criteria
* 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 separated. * Metastatic disease (M1) * Pregnancy or lactating * Surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation. * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radiation toxicity | first analysis will occur 2 year after accrual of all patients |
| Cosmetic outcome | first analysis will occur 2 year after accrual of all patients |
Secondary
| Measure | Time frame |
|---|---|
| Time to ipsilateral breast recurrence | first analysis will occur 5 year after accrual of all patients |
| Local recurrence rate | first analysis will occur 5 year after accrual of all patients |
| Disease free survival | first analysis will occur 5 year after accrual of all patients |
| Overall survival | first analysis will occur 5 year after accrual of all patients |
Countries
China
Contacts
Primary ContactZhaozhi Yang, MD
Outcome results
None listed