UK Breast Cancer in Pregnancy Study (UK BCiP study)Version 1
Research type
Research Study
Full title
UK Breast Cancer in Pregnancy Study (UK BCiP study): An observational study on newly diagnosed breast cancer in pregnancy using the UK obstetric surveillance system (UKOSS).
IRAS ID
165517
Contact name
Philip Banfield
Contact email
Sponsor organisation
University of Liverpool
Clinicaltrials.gov Identifier
14/WA/1267 , REC number
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
There is no level 1 evidence on pregnancy and breast cancer (RCOG 2011), and the RCOG guidelines admit to a paucity of knowledge in this area.
This study aims to answer the following questions:
• What is the current incidence of primary breast cancer in pregnancy in the UK?
• Are there any identifiable risk factors for breast cancer in pregnancy?
• How does breast cancer present and at what gestation?
• How is breast cancer managed in pregnancy in the UK?
• Is there variation in the timing of surgical intervention?
• What are the short-term outcomes for mother and infant?The actual incidence of breast cancer in pregnancy in the UK is unknown. Estimates from other countries range from 2.4 to 7.8 cases per 100,000 birthsThis gives an estimated 18 to 61 cases per year in the UK.
Although the incidence of breast cancer rises with age, the observation that many women are delaying their families until later in life means that the incidence of breast cancer arising for the first time in pregnancy may be rising. At the other end of the scale, for women under 30, a significant (more than 10%) of breast cancers may be associated with pregnancy, or within the year after.
The diagnosis of breast cancer in pregnant women may be difficult (Ayyappan et al 2010) and there is a potential for under-treatment of the mother and iatrogenic prematurity for the fetus. There is also an apparent contradiction between advice in Europe in general (Amant et al 2010) and UK specific advice from the RCOG about the timing of interventions and delivery (RCOG 2011). A group in Australia and New Zealand are conducting a similar study, which will make comparisons hugely informative (AMOSS).
It is clear that such cases should be managed within a multidisciplinary team within established cancer networks, in close liaison with obstetric and paediatric teams. Treatment is influenced by a number of factors, including histological grade, receptor and HER 2* status and suspicion of metastases. There is variation in approach to surgery and chemotherapy regimens that have yet to be described; a 2 – 3 week gap is recommended after last chemotherapy prior to delivery to reduce the problems of neonatal neutropenia, for example, but this may not always be possible or planned.
*Human epidermal growth factor receptor 2
REC name
Wales REC 5
REC reference
14/WA/1267
Date of REC Opinion
16 Jan 2015
REC opinion
Favourable Opinion