A trial looking at hormone replacement therapy for women who have had treatment for breast cancer

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

Cancer type:

Breast cancer




Phase 3

This trial was trying to find out if women who had been treated for early stage breast cancer could take hormone replacement therapy (HRT). This trial was supported by Cancer Research UK.

More about this trial

Many women who have had treatment for breast cancer have menopausal symptoms. This is due to either the natural menopause or as a side effect of chemotherapy and tamoxifen.

These symptoms can be very distressing for women and can interfere with everyday life. They include hot flushes, night sweats and vaginal dryness. Many women with breast cancer ask for advice about relieving menopausal symptoms caused by a lack of the female hormone, oestrogen.

Hormone replacement therapy (HRT) is a very effective way of relieving these symptoms. But it is not usually given to women with a history of breast cancer because it contains oestrogen. There are concerns that oestrogen may increase the risk of the breast cancer coming back.

This trial was trying to find out if HRT did increase the risk of breast cancer coming back after treatment.

Who can enter

You can enter this trial if you:

  • Have had stage 1 or 2 breast cancer
  • Have had no signs that your cancer has come back since you finished your initial treatment
  • Are post menopausal
  • Are having menopausal symptoms (i.e. hot flushes, night sweats or vaginal dryness)

You cannot enter this trial if you have:

  • Breast cancer has come back since you were first treated
  • Had any other cancer except non melanoma skin cancer or carcinoma in situ of the cervix
  • A history of alcohol or drug abuse
  • Any liver problems
  • Had any blood clotting problems in the past
  • Any unexplained post menopausal bleeding
  • A rare inherited condition called poryhyria

Trial design

This trial is recruiting 3000 women over 3 to 5 years. The trial is randomised. The people taking part are put into the different treatment groups by a computer.

If you are in group one, you will be given hormone replacement therapy (HRT). There are different types of HRT and your doctor will discuss with you which of these is best suited to you. If you have had a hysterectomy, you will only need to have oestrogen. If you have not had a hysterectomy, you will be given oestrogen and another hormone called progesterone (combined HRT).

If you are in group 2, you will not be given HRT, but will be given information about how to deal with your postmenopausal symptoms.

Hospital visits

Women in both groups will have the same investigations throughout the trial. A breast examination will be performed at the beginning of the trial. There is no need to have a mammogram any more often that is the normal policy at your hospital. You may be asked for urine samples to measure your oestrogen levels. You will be asked to fill in a questionnaire about your symptoms. For the first 2 years, you will be seen by a doctor at 3,6,12,18 and 24 months. At these appointments, you will have a breast examination, be asked to complete the symptom questionnaire and mya be asked to give a urine sample.

You will then be asked to go to follow up appointments every 6 months for the next 5 years, and then once a year after that.

Side effects

All drugs can have side effects.

Oestrogen only HRT can cause:

  • Feeling sick
  • Headaches
  • Breast discomfort
  • Fluid retention causing bloating similar to when you have your period and which may cause weight gain

Combined HRT (oestrogen and progesterone) can cause the same side effects. In addition, progesterone can cause pre menstrual type side effects such as:

  • Depressed mood
  • Lower abdominal pain and back ache
  • Possible light bleeding each month

HRT may also slightly increase your risk of developing a blood clot.

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Miss J Marsden
Mr Nigel Sacks

Supported by

Cancer Research UK
NIHR Clinical Research Network: Cancer

Other information

This is Cancer Research UK trial number CRUK/01/002. 

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 41

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Harriet wanted to try new treatments

A picture of Harriet

“I was keen to go on a clinical trial. I wanted to try new cancer treatments and hopefully help future generations.”

Last reviewed:

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