SUPREMO (Selective Use of Postoperative Radiotherapy AftEr MastectOmy). A phase III randomised trial to assess the role of adjuvant chest wall irradiation in *intermediate risk* operable breast cancer following mastectomy.
- Conditions
- breast cancermammary carcinoma10006291
- Registration Number
- NL-OMON55797
- Lead Sponsor
- EORTC European Organisation for Research and Treatment of Cancer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 275
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective is overall survival</p><br>
- Secondary Outcome Measures
Name Time Method <p>Evaluation of the effects of chest wall irradiation on: chest wall recurrences,<br /><br>regional recurrrences, disease free survival, metastasis free survival,<br /><br>cause-specific survival (breast cancer, cardiac and non-cardiac), and early and<br /><br>late morbidity. Molecular radiobiological differences between patients with or<br /><br>without a local recurrence.</p><br>