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Breast Cancer MortalityAgeXNCT01081288

Extending the National Health Service (NHS) Breast Screening Age Range

A study testing Invitation for breast screening in people with Breast Cancer Mortality, run by University of Oxford at 1 site in United Kingdom.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Nationwide cluster-randomised trial of extending the NHS breast screening age range in England Read more about this study

Who is it for?
Ages 47 to 73 years, women onlyHealthy volunteers can take part
Conditions the study is for
Breast Cancer Mortality
What is being tested?
Invitation for breast screening
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,000,000 participants
Where
1 siteUnited Kingdom
Study dates
Jun 2009to 31 Dec 2031
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 47 to 73 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Female, and
  • Aged 47-49 years or 71-73 years, and
  • 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).

Who cannot join

  • Anyone not satisfying the inclusion criteria

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Cancer Epidemiology Unit, Richard Doll Building, University of Oxford, Roosevelt Drive

    Oxford, OX3 7LF

Other trials in United Kingdom

About this study

Official title: Nationwide Cluster-randomised Trial of Extending the NHS Breast Screening Age Range in England

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

Read the detailed description

In 1988, the national Breast Screening Programme (BSP) began offering women aged 50-64 years triennial mammographic screening and full national coverage was achieved by the mid-1990s.

In 2003, the age range for triennial screening was extended from 50-64 to 50-70 years; proposals from committees in the Department of Health to randomise this age extension and thereby to obtain reliable information on both the risks and benefits of additional screening at ages 65-70 were not adopted.

Currently, 80 breast screening units cover all of England, each responsible for a defined area, and each year they invite about 2.8 million women aged 50-70, with 2.0 million accepting. The BSP sets standards for the screening units and monitors performance through its national quality assurance network.

In 2007, the Prime Minister announced plans for eventual extension to the range 47-73 years. This offered another opportunity to obtain reliable evidence about the effects of extending the age range of triennial screening. Hence, a trial of this age extension has begun, in which only half are offered extra screening, with the effects monitored through routinely collected NHS statistics.

Following a 2009-10 pilot study of the acceptability of cluster-randomisation of additional screening at ages 47-49 and 71-73 in 5 breast screening units, the AgeX trial extended recruitment to about five-sixths of the breast screening clinics in England, and this cluster-randomisation continues.

In 2011, the Government deferred the earliest possible date when screening would be extended to all women aged 47-73. Later, Public Health England (PHE, which is responsible for government screening programmes) stated that final decisions about extension of the age range would await the emergence of reliable evidence of its effects. The AgeX trial will eventually provide this.

In 2012, an independent panel set up by the Department of Health and the charity Cancer Research UK reported "The UK breast screening programmes [at ages 50-70] confer significant benefit and should continue…. The impact of breast screening outside the ages 50-69 years is very uncertain. The Panel supports the principle of the ongoing trial in the UK [AgeX] for randomising women under age 50 and above age 70 to be invited for breast screening".

Meanwhile, as female life expectancy is increasing, interest has grown in the possible advantages of continuing to screen women not just in their early 70s but throughout their 70s. The advantages and the disadvantages of continuing triennial screening after age 70 would be seen more clearly in a trial of 2 or 3 additional invitations (covering ages 71-76 or 71-79) than in a trial of just one.

In 2013 the All-Party Parliamentary Group on Breast Cancer in Older Women (APPG) said "Women are not routinely invited for breast screening past the age of 70 … the current 'age extension trial' [of screening past age 70] … should be extended past 73 to 76, and, if appropriate … further extended". In a separate report in 2015 the APPG reiterated this conclusion.

Although AgeX began as a trial of additional screening at ages 47-49 and at ages 71-73, it has therefore become a trial in which the older women allocated additional screening can, where resources are available, continue be invited triennially at ages 71-76 or at ages 71-79, thereby assessing the effects of continuing triennial screening for several years after age 70.

Being tested
Invitation for breast screening
Keywords
Breast cancer, Breast screening, Mammography, Routine screening programme
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Invitation for breast screeningOther

    Invitation for breast screening to women in different age groups

Study groups in NCT01081288
Study groupRoleWhat they receive
Women aged 47-49 invited for breast screeningActive comparatorNot described
Receives: Other: Invitation for breast screening
Women aged 71-73 invited for breast screeningActive comparatorNot described
Receives: Other: Invitation for breast screening

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Breast cancer mortality

    Measured: 17 years

Secondary outcomes (3)
  1. Breast cancer incidence, up to the same date that the primary outcome (breast cancer mortality) is reported

    Measured: 17 years

  2. Breast cancer treatments, including use of mastectomy, chemotherapy and radiotherapy, up to the same date that the primary outcome (breast cancer mortality) is reported

    Measured: 17 years

  3. All-cause mortality, up to the same date that the primary outcome (breast cancer mortality) is reported

    Measured: 17 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2010 (estimated)
  2. Study startJun 2009
  3. Primary completion31 Dec 2031 (estimated)
  4. Study completion31 Dec 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
4,000,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01081288
Sponsor's protocol ID
10/H0710/9
Acronym
AgeX
Status last verified
Dec 2025
First submitted
3 Mar 2010
Last updated
19 Dec 2025
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Invitation for breast screening in people with Breast Cancer Mortality, run by University of Oxford at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Breast cancer mortality (time frame: 17 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.

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