Breast cancer mortality Cancer Malignant neoplasm of the breast
Conditions
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
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 alloc
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 e
Sponsors
University of Oxford (UK)
Eligibility
Sex/Gender
Female
Age
47 Years to 73 Years
Inclusion 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
Exclusion criteria: Does not meet inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome(s) as of 08/04/2026: The primary analyses will be of the effects of one additional screening visit on numbers of deaths from a breast cancer diagnosed < 4 years after randomisation that occurred after reaching age 55 (for younger women) or after reaching age 75 (for older women). _____ 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
| Measure | Time frame |
|---|---|
| Current key secondary outcome(s) as of 08/04/2026: The main subsidiary analyses will be of breast cancer incidence and treatment. Additional subsidiary analyses will investigate any effects of screening on other outcomes that are available from linkage with routinely collected NHS records. The final primary and subsidiary analyses will be accompanied by appropriate health economic analyses. _____ 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 | — |
Countries
England, United Kingdom
Outcome results
None listed