PEARL
Research type
Research Study
Full title
A window of opportunity study to assess the biological effects of progesterone in premenopausal ER-positive, PgR-positive early breast cancer
IRAS ID
225455
Contact name
Carlo Palmieri
Contact email
Sponsor organisation
University of Liverpool
Eudract number
2017-001521-41
Duration of Study in the UK
1 years, 3 months, 1 days
Research summary
Summary of Research
This is a study where patients will be given an extra drug before they have their operation to remove the breast cancer. We want to look at what will happen inside the cancer and what affect these drugs are having on the growth of the cancer. We will be looking at women who have a specific type of breast cancer (ER-positive and PgR-positive) who have not yet gone through the menopause.Half the patients will be given one drug called tamoxifen and the other half will get two drugs tamoxifen and micronized Progesterone. Patients will take these drugs for 14 days before they come into hospital for the operation to remove their cancer tumour.
We will then take the samples of each patient’s breast cancer and compare them to see whether the drugs have an effect of the tumour. This will be done by looking at a test called the Ki67 proliferation index. This test tells us how fast the cancer is growing and s done in the laboratory by special doctors called pathologists.
The study will not delay any surgery and after surgery patient will return to the normal NHS care pathway for their disease.
Summary of Rsults
At the time of writing this report sample data had not been analysed and therefore the primary outcome
cannot be assessed.REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
17/NW/0460
Date of REC Opinion
11 Sep 2017
REC opinion
Further Information Favourable Opinion