A study looking at the changes in the breast cancer of postmenopausal women having hormone therapy (Primary Endocrine Response Study)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Breast cancer

Status:

Closed

Phase:

Phase 3

This study is looking at the early changes that occur in the breast cancer cells of postmenopausal women who are taking hormone therapy.

Postmenopausal women with large or locally advanced breast cancer that is oestrogen receptor (ER) positive may start their treatment with a type of hormone therapy called an aromatase inhibitor. Aromatase inhibitors are a group of drugs that work by blocking oestrogen made in the body.

In this study the researchers want to compare samples of breast cancer tissue, before and during hormone therapy, to see if there are changes in breast cancer cells.

The aims of this study are to

Find out what changes there are to breast cancer cells after 2 weeks of aromatase inhibitors
Find out if these changes can be used to predict the response of breast cancer to longer term treatment

Who can enter

You can enter this trial if you

Have breast cancer that is locally advanced
Have breast cancer that is bigger than 2cm
Have oestrogen receptor (ER) positive breast cancer breast cancer
Are a postmenopausal woman

You cannot enter this trial if you

Have breast cancer that has spread to another part of your body

Trial design

This phase 3 study will recruit women from the Edinburgh Breast Unit at the Western General Hospital, Edinburgh. To start with, 40 women will be recruited so that the researchers can look for changes in breast cancer cells. Another 40 women will then be recruited to test if these changes can be used to tell in advance how breast cancer may respond to aromatase inhibitor treatment.

In this study the researchers are using an aromatase inhibitor called letrozole. All women taking part in this study will take letrozole tablets for 3 months.