SUPREMO

This study is currently recruiting !

(Selective Use of Postoperative Radiotherapy aftEr  MastectOmy)

Study Title

A randomised phase III trial assessing the role of chest wall irradiation in women with intermediate risk breast cancer following mastectomy.

Basic Study Information

Chief Investigator: Prof Ian Kunkler
Sponsor: Edinburgh University, ISD & NHS Lothian

Phase: III
Study Status: recruiting
Cancer Type: Breast
ISRCTN No: 61145589
Ethical Approval: Fife & Forth Valley Local Research Ethics Committee

Study schema

Objectives

• To determine the effect of ipsilateral chest wall irradiation following mastectomy and axillary clearance for women with operable breast cancer at 'intermediate risk' of loco-regional recurrence on overall survival.

Sub studies:

• Biological sub study (TRANS-SUPREMO)
• Cardiac sub study (UK only)
• Quality of life sub study (UK only)
• Health economic sub study (UK only)

Outcomes

Primary

• Overall survival

Secondary

• Chest wall recurrence
• Regional recurrence
• Disease-free survival
• Metastasis-free survival
• Cause of death (Breast cancer, Intercurrent disease [cardiovascular and non- cardiovascular])
• Acute and late morbidity
• Quality of Life
• Cost effectiveness

Eligibility Criteria

Inclusion Criteria

1. pT1, pN1, M0  unilateral histologically confirmed invasive breast cancer
2. pT2, pN1, M0 unilateral histologically confirmed invasive breast cancer
3. pT2, pN0 unilateral histologically confirmed invasive breast cancer if grade III histology and/or lymphovascular invasion
4. Multifocal breast cancer if largest discrete tumour at least 2cm if N0 and grade III histology and/or lymphovascular invasion [see NB (ii)]
5. If the tumour area comprises multiple small adjacent foci of invasive carcinoma then overall maximum dimension taken. This must be greater than 2cm if N0 and grade III histology and/or lymphovascular invasion [see NB (iii)]
6. Fit for adjuvant chemotherapy (if indicated), adjuvant endocrine therapy (if indicated) and postoperative irradiation
7. Undergone total mastectomy (with minimum of 1mm clear margin of invasive cancer and DCIS) and axillary staging procedure
   -    If axillary node positive (1-3 positive nodes [including micrometastases >0.2mm-≤2mm]) then an axillary node clearance  (minimum of 10 nodes removed) should have been performed. Isolated tumour cells do not count as micrometastases
   -    Axillary node negative status can be determined on the basis of either axillary clearance or axillary node sampling or sentinel node biopsy
8. Written, informed consent
   NB (i) Patients undergoing immediate breast reconstruction are eligible for inclusion.
   NB (ii) Multifocal breast cancer if largest focus conforms to the other eligibility criteria.  So if NO disease the primary tumour has to have at least one focus size pT2 with grade 3 histology or lymphovascular invasion (criterion 3) or pT1 or pT2 if N1 (criteria 1 and 2). 
   NB (iii) Criterion 5 is the definition of what is considered pT2 disease for N0 cases (pT1 is also allowed if N1). 

Exclusion Criteria

1. Any pT0, pN0-1, or pT1, pN0 or pT3, pNO-1 or pT4
2. Patients who have 4 or more pathologically involved axillary nodes
3. Patients who have undergone neoadjuvant systemic therapy
4. Previous or concurrent malignancy other than non melanomatous skin cancer and carcinoma in situ of the cervix
5. Male 
6. Pregnancy
7. Bilateral breast cancer
8. Known BRCA1 and BRCA2 carriers
9. Not fit for surgery, radiotherapy or adjuvant systemic therapy
10. Internal mammary nodes visible on sentinel node scintigraphy in the absence of negative histology
11. Unable or unwilling to give informed consent

Recruitment

Target Recruitment: 1600      
Current Recruitment: 805          

Key Dates

Accrual Opening date: Jun 2006
Planned Accrual Completion date: Dec 2012
Planned Study Completion date: Dec 2022

Registration information

Randomisation service Mon - Fri 9am - 5pm (UK time)
Tel: 0131 275 7276
Fax: 0131 275 7512

Main contact: jlipscombe@nhs.net

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