
“Deborah agreed to take part in a trial as she was keen to help other cancer patients in the future. "If taking part in a trial means others might be helped then I’m very happy with that."
This trial was for women whose breast cancer had come back in the same place or had spread to another part of the body (advanced breast cancer).
Their cancer also had to be:
Hormone receptor positive means that breast cancer cells have for the hormones oestrogen and progesterone. HER2 negative is when cancer cells don’t have receptors for the
.
Hormone therapy is often used to treat hormone receptor positive breast cancer. Letrozole (Femara) is one type of hormone therapy. Doctors use it as a treatment for breast cancer in women who are .
Ribociclib (LEE011) is a type of targeted cancer drug called a cancer growth blocker. It stops signals that cancer cells use to divide and grow.
The researchers wanted to find out if ribociclib alongside letrozole helps women with advanced breast cancer. In this trial, women had 1 of the following:
The aims of this trial were to:
The trial team concluded that ribociclib alongside letrozole helps women with advanced breast cancer.
This was a phase 3 trial. 668 women with advanced breast cancer took part. Everyone had hormone receptor positive breast cancer and HER2 negative breast cancer.
This was a randomised trial. Women were put into 1 of the following treatment groups by computer:
Neither they nor their doctor could choose which group they were in.
Everyone had treatment for as long as their cancer stayed the same and didn’t get worse. When their cancer got worse (), women stopped having treatment.
Some people were still having treatment at the time the study team looked at the results. So, the team looked at how well ribociclib worked for all women after 18 months of treatment.
To do this, doctors looked at the number of women who had no signs of their cancer getting worse after 18 months of treatment. This is called progression free survival. They found it was:
The team also looked at the most common side effects women had. They were:
The team found that women in the ribociclib and letrozole group had worse side effects than women in the dummy drug and letrozole group.
So, the trial team concluded that ribociclib alongside letrozole helps women with advanced breast cancer. They will continue to look at the results until all women finish their treatment.
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists () 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.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor David Cameron
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
Novartis
Freephone 0808 800 4040
“Deborah agreed to take part in a trial as she was keen to help other cancer patients in the future. "If taking part in a trial means others might be helped then I’m very happy with that."