MEDICI

• Research type

  Research Study

• Full title

  Mammographic Predictors of Cancer Recurrence after Breast Conservation and Adjuvant Endocrine Therapy

• IRAS ID

  260722

• Contact name

  Kulsam Ali

• Contact email

  k.z.ali@dundee.ac.uk

• Sponsor organisation

  University of Dundee

• Clinicaltrials.gov Identifier

  v 1.1 06/06/2019, protocol approved by sponsor

• Duration of Study in the UK

  3 years, 8 months, 31 days

• Research summary

  Summary of Research

  Female hormones can help some breast cancers to grow. So most women who have had breast cancer are put on endocrine therapy such as tamoxifen which stops oestrogen from helping the cancer to grow. However in some women the cancer comes back while they are on endocrine therapy. Often we learn too late that the
  treatment wasn’t working so we need to know much sooner whether it’s effective.
  We can tell from mammograms how dense a woman’s breast tissue is. For some women their breasts become less dense while they are on endocrine therapy. We think that might mean that the treatment is working. We think if a woman’s breasts remain dense while on treatment, her cancer may be more likely to come back. The
  aim of this study is to prove whether a reduction in breast density really does mean that the endocrine therapy is keeping the cancer away.
  We have identified 2500 women who have been recruited into a research project called Mammo50. These women are all over 53 years old, have had a lump removed. 2000 are on endocrine therapy and did not have chemotherapy. We want to transfer their mammograms to a central imaging centre and use a computer and radiologists to assess if the breast tissue has become more or less dense. (We will also look at mammograms from 500 similar women who did not have endocrine therapy as a control group). The progress of these women is then followed so that we will then see if a change in density of the breast tissue is related to the effectiveness of the endocrine therapy.

  Summary of Results
  The aim of this study was to find out if a change in the density of breast tissue (as seen on a mammogram) could allow doctors to predict whether hormone-blocking therapy was working. This type of treatment is called adjuvant endocrine therapy, (AET) and is given after surgery to reduce the risk of a cancer coming back (recurrence) and the risk of dying from breast cancer.
  We used several ways to estimate breast density on mammography, and we showed that:
  • It is important to have a test set of mammograms to assess how good readers are at measuring density. One of the readers was significantly different from the rest and so this reader did not take part in the main study.
  • Overall, expert readers can judge the amount of dense breast tissue on a mammogram using a scale from 0-100%
  • Computer programs can be designed using artificial intelligence (AI) to measure breast density. This worked no matter which mammogram machine was used
  Previous small studies suggested that it was a good sign if breast density decreased while a woman was taking AET; it was less likely that their cancer would come back and less likely that they would die from breast cancer. The results of this study are different. We showed that:
  • In breast cancer patients aged over 50 taking hormone therapy, a change in breast density does not seem to be related to how likely they are to die from breast cancer
  • In breast cancer patients aged over 50 taking hormone therapy, a change in breast density does not seem to be related to how likely it is that the breast cancer will come back

• REC name

  West of Scotland REC 4

• REC reference

  19/WS/0112

• Date of REC Opinion

  12 Aug 2019

• REC opinion

  Favourable Opinion