breast cancer mammary carcinoma
Conditions
Interventions
One randomisation group recieves chest wall irradiation, 40-50 Gy in 15-25
fractions over 3-5 weeks, and the controle group does not have radiotherapy.
Sponsors
EORTC European Organisation for Research and Treatment of Cancer
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. 1 Stage II histologically confirmed unilateral breast cancer following mastectomy including the following pTNM stages: -pT1, pN1, M0 -pT2, pN1, M0 -pT2, pN0 if grade III histology and/or lymphovascular invasion. -pT3N0M0 If the tumour area comprises multiple small adjacent foci of invasive carcinoma then overall maximum dimension taken to determine the T staging. Multifocal or multicentric tumours can be included. The size of the largest tumour determines the T stage classification. 1.2 Stage II histologically confirmed unilateral breast cancer following neoadjuvant systemic therapy and mastectomy, if the original clinical stage was cT1-2cN0-1 or cT1-2pN1(sn)M0 and with the following (ypTNM) stages after neoadjuvant systemic therapy: - ypT1N1M0 - ypT2pN1M0 - ypT2pN0M0 if grade III histology and/or lyphovascular invasion - ypT0pN0 or ypT1pN0 or ypT0pN1 9pathological complete remission or near complete remission) -ypT2N0, independant of grade or lymphovascular invasion, if the priginal stage was cT3N0 also: -ypT3N0M0, if the original clinical staging was cT1-3cN0M0 or cT1-3pN0 (sn) M0, 1.3 Unilateral invasive breast cancer that conforms to the initial clinical staging of criterion 1, but has been downstaged by neoadjuvant systemic therapy to ypT0N0 or ypT1pN0 or ypT0N1 (pathological complete remission or near complete remission). If the tumour stage cT3 or ypT3, then nodal status must be N0 both before ans after neoadjuvant systemic therapy., 2. Undergone total mastectomy (with minimum of 1 mm clear margin of invasive cancer and DCIS) and axillary staging procedure., 3.1 If axillarynode positive (1-3 positive nodes[including micrometastases >0.2 mm->= 2mm]) then an axillary node clearance (minimum 8 nodes removed) should have been performed. Isolated tumour cells do not count as micrometastases., 3.2 Axillary node status can be determined on the basis of either axillary clearance or axillary node sampling or sentinel node biopsy., 3.3 Sentinel nodes identified in the internal mammary chain are considered pN1b or pN1c if histologically proven. Patients can be included in the trial with microscopic metastasis in the internal mammary chain detected by sentinel node biopsy, if not more than 3 tumour positive nodes in axillaey lymph nodes. If not biopsied, internal mammary chain sentinel nodes are considered tumour negative for staging., 3.5 Before neoadjuvant systemic therapy, axillary ultrasound is advised. Abnormal axillary nodes based on imaging (mammogram or ultrasound) should be sampled by guided needle sampling or core biopsy. Where axillary ultrasound is normal, negative axillary node status does not require histological confirmation before starting neoadjuvant systemic therapy. Positive, or negative, nodal status may also be determined by sentinel node biopsy before start of neoadjuvant therapy. 4. Fit for adjuvant chemotherapy (if indicated), adjuvant endocrine therapy (if indicated) and postoperative irradiation. axillary node sampling or sentinel node biopsy. 5. Written, informed consent. NB Patients undergoing immediate breast reconstruction are eligible for inclusion.
Exclusion criteria
Exclusion criteria: 1. Any pT0pN0-1,or pT1pN0 tumours after primary surgery. 2. Any pT3pN1 or pT4 tumours. Initial stage cT3cN1 or pN1(sn) or cT4 in patients receiving neoadjuvant systemic therapy cannot be included, even if downstaging has occured and the pathological ypT and N stage is lower. 3. Patients who have 4 or more pathologically involved axillary nodes. For the purpose of this study protocol, nodal scaring after neoadjuvant systemic therapy will be considered as evidence of previous pathological nodal involvement and count towards the total number of involved axillary nodes. 4. Past history or current diagnosis of ductal carcinoma in situ (DCIS) of the contralateral breast, unless treated by mastectomy. Previous DCIS of the ipsilateral breast if treated with radiotherapy (i.e. previous DCIS treated by conservation surgery not followed by radiotherapy would be considered eligible.) 5. Bilateral breast cancer. However, patients who have undergone a prophylactic contralateral mastectomy can be included, if the breast was pathologically free of invasive tumour. 6. Previous or concurrent malignancy other than non melanomatous skin cancer and carcinoma in situ of the cervix. For previous DCIS see criterion 4., 7. Male , 8. Pregnancy, at the time of radiotherapy treatment., 9. Not fit for surgery, radiotherapy or adjuvant systemic therapy, 10. Unwilling or unable to give informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of the effects of chest wall irradiation on: chest wall recurrences, regional recurrrences, disease free survival, metastasis free survival, cause-specific survival (breast cancer, cardiac and non-cardiac), and early and late morbidity. Molecular radiobiological differences between patients with or without a local recurrence. | — |
Countries
Netherlands
Outcome results
None listed