Mastectomy - Clinical trial details 

Recruitment status:

Recruiting

Primary Sponsor:

University of Oxford (UK)

Recruitment countries:

United Kingdom

Health condition studied:

Breast cancer mortality
Cancer
Malignant neoplasm of the breast

URL:

Link to the clinical trial website

About the trial

Interventions:

Description of interventions as of 28/09/2016:
Randomisation is by cluster. In the routine BSP, a national database is used to create screening invitation batches, typically every few weeks, for each local breast screening unit. An invitation batch typically lists several hundred women of appropriate age who are recorded (in the local screening database) as registered with the same general practitioner or living in the same geographical locality (e.g., one village, or one part of a town) where the local breast screening unit will next be working. Once generated, this batch is used by the local breast screening unit to invite the women in it for mammography.
Before the trial began, batches would have included women aged 50-70 years (by the end of the current year). During the trial, batches include women aged 47-73 rather than only those aged 50-70; in other words, in addition to the 50-70 age group, they now include the new entrants into the trial, who are the cluster of age 47-49 and the cluster of age 71-73 years.
Each batch is randomly allocated to invite for screening either the trial entrants aged 47-49 or those aged 71-73 years, as shown in the figure. (The women aged 50-70 are unaffected by the random allocation of the batch; they are invited as normal and are not new entrants into the trial). The batch will also include trial participants invited 3 years ago at ages 71-73 (but now aged 74-76) for a second invitation and eventually those invited 3 years ago at ages 74-76 (but now aged 77-79) for a third invitation.
The random allocation of each batch is done by a specially written computer program with equal (50/50) probability and no stratification. A small proportion of women are excluded before randomisation because, for example, they have asked to be withdrawn from the national breast screening programme, are recorded as having had a bilateral mastectomy, or had been screened recently.
Each participant enters the trial on the date when the screening bat

Key inclusion and exclusion criteria:

• Inclusion criteria: 1. Female
  2. Aged 47 - 49 years or 71 - 73 years
  2. In a Breast Screening Unit participating in the study. All Breast Screening Units in England are expected to participate in the study with the exception of a few that use non-standard methods for creating screening batches
• Exclusion criteria: Does not meet inclusion criteria

• Age minimum: 
• Age maximum: 
• Gender:  Female

Primary outcomes:

Description of primary outcome measures as of 28/09/2016
1. The primary analyses among older women will be of breast cancer mortality:
1.1. Up to but not including age 80, and, eventually
1.2. Subdivided by separate time periods (0-4, 5-9, 10-14, etc years after the exact date of randomisation) and by receptor status (ER+, other)
2. The primary analyses among younger women will be of breast cancer mortality:
2.1. Up to but not including age 60, and, eventually
2.2. Subdivided by separate time periods (0-4, 5-9, 10-14, etc years after the exact date of randomisation) and by receptor status (ER+, other)

Description of primary outcome measures as of 17/03/2015:
Breast cancer mortality

Previous description of primary outcome measures:
Mortality from breast cancer by age 60 for women invited to have an additional early screen (before age 50) versus those not invited, and by age 80 for women invited to have an additional late screen (after age 70) versus those not invited

Secondary outcomes:

Description of secondary outcome measures as of 04/10/2016:
1. Breast cancer incidence, up to the same date that the primary outcome (breast cancer mortality) is reported
2. Hospital admissions for mastectomy and lumpectomy, up to the same date that the primary outcome (breast cancer mortality) is reported
3. All-cause mortality, up to the same date that the primary outcome (breast cancer mortality) is reported

Description of secondary outcome measures as of 17/03/2015:
1. Breast cancer incidence
2. Hospital admissions
3. Investigation, detection and treatment of breast lesions
4. Overall and cause-specific mortality

Previous description of secondary outcome measures:
1. Breast cancer registrations in the screened and unscreened groups
2. A range of other medical outcomes, including screening outcomes in women invited for screening

Target sample size:

3000000

Study type:

Interventional

Study design:

Multicentre cluster randomised trial (Screening)

Contacts:

• Name:  
• Address: 
• Phone: 
• Email: 
• Affiliation: 

• Name: Julietta Patnick
• Address:  Cancer Epidemiology Unit Richard Doll Building University of Oxford Roosevelt Drive
• Phone: 
• Email: 
• Affiliation: 

Technical details

Scientific title:

Nationwide cluster-randomised trial of extending the NHS breast screening age range in England

Sources of monetary support:

Department of Health funds allocated to Public Health England, Study co-ordination and data analysis is funded from the quinquennial core support for the Cancer Epidemiology Unit and for the Clinical Trial Service Unit (both in the University of Oxford’s Nuffield Department of Population Health) from Cancer Research UK and the Medical Research Council

Secondary sponsors:

Main ID:

ISRCTN33292440

Secondary ID:

NCT01081288
10/H0710/9

Register:

ISRCTN

Date of registration:

22/02/2010

Date of first enrollment:

01/06/2009

Last refreshed:

7 November 2016