A trial looking at ovarian protection for premenopausal women having chemotherapy for breast cancer (OPTION)

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Cancer type:

Breast cancer

Status:

Results

Phase:

Phase 3

This trial was trying to find out if goserelin (Zoladex) could protect the ovaries, and so prevent early menopause, in women who were having chemotherapy for breast cancer Open a glossary item. Cancer Research UK supported this trial.

More about this trial

Doctors often treat breast cancer with chemotherapy Open a glossary item. But chemotherapy damages the ovaries in up to 8 out of 10 women (80%) who have not been through the menopause (are premenopausal). This damage can cause early menopause. This can be distressing, and can also lead to osteoporosis.

Goserelin (Zoladex) is a type of hormone therapy Open a glossary item that usually stops the ovaries working. In this trial, doctors hoped that if they could stop the ovaries working while the women had chemotherapy, the chemotherapy would be less likely to damage their ovaries. 

The aim of this trial was to see if goserelin could help prevent early menopause caused by chemotherapy.

Summary of results

The trial team found that goserelin prevented early menopause caused by chemotherapy to some degree in women younger than 40 years. It was uncertain whether it prevented it in women over 40. 

This was a randomised trial Open a glossary item. The trial team recruited 227 women. A computer put the women who were taking part into 2 treatment groups. Neither they nor their doctor was able to decide in which group they were.

Women in group 1 had 6 - 8 cycles of chemotherapy alone. The drugs they had depended on their situation.

Women in group 2 also had 6 - 8 cycles of chemotherapy, as well as goserelin (Zoladex) injections. They had the goserelin injections 1-2 weeks before starting chemotherapy and then every 3-4 weeks until the end of chemotherapy.

All the women had a follow-up every 6 months for 2 years, then every 12 months for 3 years. The researchers checked their hormone levels:

  • at cycle 3
  • after the final cycle
  • at 9 months after treatment finished 
  • at12 months after treatment finished
  • then yearly

All the women kept a diary of their menstrual cycle Open a glossary item for 24 months from the start of chemotherapy.

Around 19 out of every 100 women (18.5%) who had goserelin had an early menopause. In women who had chemotherapy only, about 35 out of every 100 (34.5%) had an early menopause.

Women younger than 40 years old 

  • Those who had goserelin, about 3 out of every 100 (2.6%) had an early menopause. 
  • Those  who had chemotherapy only, 20 out of 100 (20%) had an early menopause.

Women older than 40 years
The effect of goserelin was less clear in women older than 40 years old. 

  • Those who had goserilin, around 42 out of every 100 women (42.3%) had an early menopause. 
  • Those who had chemotherapy only, around 47 out of every 100 (47.2%) had an early menopause.

The researchers also found that although goserelin had caused bone thinning (osteoporosis) to happen quicker during treatment, bones recovered sooner once treatment had stopped. These results showed researchers that goserelin protected the ovaries well enough by cancelling out the long-term bone-thinning effect of early menopause.

We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.

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

Professor Rob Leonard

Supported by

Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer

Other information

This is Cancer Research UK trial number CRUK/04/004.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

336

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

Caroline took part in a clinical trial for breast cancer

“I had treatment last year and I want to give something back.”

Last reviewed:

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