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A window of opportunity study to assess the biological effects of progesterone in premenopausal Estrogen Receptor-positive, Progesterone Receptor-positive early breast cancer

PEARL

A window of opportunity study to assess the biological effects of progesterone in premenopausal Estrogen Receptor-positive, Progesterone Receptor-positive early breast cancer
Funding CRUK
Portfolio Cancer
Interventions Medicine
Randomised Yes
Status Recruiting
Start Date 17-Jul-2019

A trial looking at progesterone to treat early breast cancer in premenopausal women. 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.

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