Mastectomy - Clinical trial details 

Recruitment status:

Recruiting

Primary Sponsor:

Medical Research Council

Recruitment countries:

United Kingdom

Health condition studied:

Breast Cancer

URL:

Link to the clinical trial website

About the trial

Interventions:

Procedure: standard follow-up care
Radiation: radiation therapy

Key inclusion and exclusion criteria:

• 
  DISEASE CHARACTERISTICS:
  
  - Histologically confirmed unilateral invasive breast cancer
  
  - pT1, pN1, M0 disease
  
  - pT2, pN1, M0 disease
  
  - pT2, pN0 disease with grade III histology and/or lymphovascular invasion
  
  - Multifocal breast cancer meeting both of the following criteria:
  
  - Largest discrete tumor = 2 cm if N0
  
  - Grade III histology and/or lymphovascular invasion
  
  - No bilateral breast cancer
  
  - Axillary node negative status by axillary clearance, axillary node sampling, or
  sentinel node biopsy
  
  - Patients with axillary node positive (1-3 positive nodes, including
  micrometastases* > 0.2 mm and = 2 mm) must have had an axillary node clearance
  (minimum of 10 nodes removed) performed
  
  - No more than 3 pathologically involved lymph nodes
  
  - No internal mammary nodes visible on sentinel node scintigraphy in the absence
  of negative histology NOTE: *Isolated tumor cells not counted as micrometastases
  
  - Underwent total mastectomy (with minimum of 1 mm margin clear of invasive cancer and
  DCIS) and axillary surgery with staging procedure
  
  - Must have undergone adjuvant systemic chemotherapy if indicated for
  intermediate-risk breast cancer
  
  - Patients undergoing immediate breast reconstruction allowed
  
  - No known BRCA1 and BRCA2 carriers
  
  - Hormone receptor status not specified
  
  PATIENT CHARACTERISTICS:
  
  - Menopausal status not specified
  
  - Not pregnant
  
  - Fit for adjuvant chemotherapy, adjuvant endocrine therapy, and post-operative
  radiotherapy
  
  - No prior or concurrent malignancy except curatively treated nonmelanomatous skin
  cancer or carcinoma in situ of the cervix
  
  PRIOR CONCURRENT THERAPY:
  
  - See Disease Characteristics
  
  - No concurrent trastuzumab
  
  - No prior neoadjuvant systemic therapy
  

• Age minimum:  N/A
• Age maximum:  N/A
• Gender:  Female

Primary outcomes:

Acute and late morbidity
Overall survival

Secondary outcomes:

Cause of death (breast cancer, or intercurrent disease [cardiovascular or non-cardiovascular])
Chest wall recurrence
Cost effectiveness
Disease-free survival
Metastasis-free survival
Quality of life
Regional recurrence

Target sample size:

3500

Study type:

Interventional

Study design:

Allocation: Randomized, Primary Purpose: Treatment

Contacts:

• Name:   Ian H. Kunkler, MD
• Address: 
• Phone: 
• Email: 
• Affiliation:  Edinburgh Cancer Centre at Western General Hospital

Technical details

Scientific title:

Selective Use of Postoperative Radiotherapy AftEr MastectOmy - SUPREMO

Sources of monetary support:

Please refer to primary and secondary sponsors

Secondary sponsors:

Main ID:

NCT00966888

Secondary ID:

ISRCTN61145589
CDR0000642751
EU-20943
MRC-BIG2-04

Register:

ClinicalTrials.gov

Date of registration:

26/08/2009

Date of first enrollment:

January 2006

Last refreshed:

19 February 2015