Read press release A trial of a short course of hormone therapy before and after surgery for early breast cancer (POETIC)
This trial is looking at whether having hormone therapy for 2 weeks before and 2 weeks after surgery helps postmenopausal women with breast cancer. This trial is supported by Cancer Research UK.
The first treatment for early breast cancer is usually surgery. After surgery, women who have hormone receptor positive breast cancer will have hormone therapy as part of their treatment. Most women have hormone therapy for at least 5 years. This helps to reduce the risk of breast cancer coming back.
Drugs called aromatase inhibitors are a type of hormone therapy for women who have gone through the menopause. In this trial, doctors want to find out if having an aromatase inhibitor for 2 weeks before and after surgery, as well as standard hormone therapy, helps reduce the risk of breast cancer coming back even more.
The researchers will also look at testing the cancer cells to see if there are any changes after a short course of hormone therapy. In the future, this may help doctors to work out which treatment is best for each individual patient. The aims of the trial are to
- See if 4 weeks of an aromatase inhibitor at the time of surgery helps to reduce the risk of early breast cancer coming back
- Find out if testing the cancer cells after 2 weeks of hormone therapy can help to predict how well a woman will respond to treatment
Recruitment
Phase
Who can enter
You can enter this trial if you
- Have been diagnosed with hormone receptor positive breast cancer
- Are over 50 years of age and either stopped having periods at least a year ago, or have had an operation to remove both ovaries (if you are under 55 and have recently had a hysterectomy but still have your ovaries, or have taken HRT in the last year, your doctor will do blood tests to see if you have gone through the menopause)
- Are well enough to carry out all your normal activities, apart from heavy physical work (performance status 0 or 1)
You cannot enter this trial if you have
- Cancer that cannot be removed with surgery or is locally advanced
- Cancer that has spread somewhere else in your body (metastatic cancer)
- Two or more tumours in your breast which have different hormone or protein receptors - the trial team can advise you about this
- Had breast cancer before or have breast cancer in both breasts
- Taken HRT or any other medicine containing oestrogen in the last 4 weeks
- Have ever had oestrogen implants
- Have been taking steroids on a long term basis
- Already had hormone therapy or chemotherapy for breast cancer
- Had any other cancer in the last 5 years, apart from basal cell skin cancer or carcinoma in situ of the cervix
- Any other serious medical condition
- Had an experimental drug as part of another clinical trial in the last 4 weeks
- Take steroids on a long term basis
Trial design
This trial will recruit about 4,350 women. It is a randomised trial. The people taking part are put into one of 2 treatment groups. Neither you nor your doctor will be able to decide which group you are in. Two thirds of the women will be in group 1, and one third will be in group 2.
Women in group 1 will take an aromatase inhibitor each day for 2 weeks before surgery and 2 weeks after. Some hospitals will use a drug called anastrozole, others will use letrozole. After surgery, the women in this group will have the standard treatment appropriate for their situation.
Women in group 2 will have surgery, followed by the standard treatment appropriate for their situation.
Taking part in the trial will not delay your surgery.
The researchers will collect samples of tissue
- Taken when you had a biopsy to diagnose breast cancer
- At the time of your surgery to remove breast cancer
They will be able to compare the tissue samples from women who have and have not had an aromatase inhibitor before surgery.
The trial team will also ask to take blood samples from you
- At the beginning of the trial
- When you have surgery
- On one occasion after surgery
If you don’t want to give these extra blood samples for research you don’t have to. You can still take part in the trial.
Hospital visits
You will have extra blood tests when you join the trial and again 2 weeks after surgery. Other than that, there will be no extra hospital visits as a result of taking part in this trial.
Side effects
The side effects of aromatase inhibitors are usually mild but include
- Joint stiffness
- Tiredness
- Hot flushes
- Vaginal dryness or irritation
- Slight hair thinning
- Headache
There is more information about anastrozole and letrozole on CancerHelp UK.
Location of trial
For more information
Please note: we cannot help you to join a specific trial. Unless we state otherwise in this trial summary, you need to print this page and take it to your own doctor to discuss.
Find out how to join a trial or contact our cancer information nurses for other questions about cancer by phone (0808 800 4040), by email, or at
Cancer Research UK
Angel Building
407 St John Street
London
EC1V 4AD
Chief Investigator
This is Cancer Research UK trial number CRUK/07/015.
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