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:
Status:
Phase:
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.
Hospital visits
You will see the doctor and have some tests before taking part in the study.
These tests include
- Breast examination
- Mammogram
- Ultrasound
- Biopsy
After 2 weeks you have another biopsy.
During treatment you will see the doctor regularly and have a breast examination, mammogram and ultrasound.
Side effects
The most common side effects of letrozole are
- Tiredness (fatigue)
- Hot flushes or increased sweating
- Weight gain
- Rash or itchy skin
- Headache
- Loss of appetite
- Being or feeling sick
- Constipation
- Diarrhoea
- Stomach upset
- Painful muscles, joints or bones
You can find more about letrozole on CancerHelp UK.
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Chief Investigator
Mike Dixon
Supported by
Experimental Cancer Medicine Centre (ECMC)
Lothian Health Board
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
