A trial looking at LCL161 and paclitaxel before surgery for triple negative breast cancer

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Cancer type:

Breast cancer

Status:

Results

Phase:

Phase 2

This trial looked at LCL161 with paclitaxel for breast cancer that doesn’t have receptors for progesterone, oestrogen or HER2. This is called triple negative breast cancer.

More about this trial

Some breast cancers have receptors for the hormones oestrogen or progesterone, or for the protein HER2. Doctors often treat these cancers with hormone therapies or a targeted treatment called trastuzumab (Herceptin).
 
But some cancers don’t have any of these receptors. This is called triple negative breast cancer. Doctors can’t use hormone therapies or trastuzumab to treat these cancers so they often use chemotherapy instead. One chemotherapy drug they use is paclitaxel (Taxol).
 
LCL161 is a type of cancer growth blocker. It stops the signals that cancer cells need to divide and grow. Doctors hoped that LCL161 would help paclitaxel work better.
 
In this trial the researchers compared a combination of paclitaxel and LCL161 with paclitaxel alone. 
 
The aims of this trial were to find out:
  • how well LCL161 with paclitaxel works for triple negative breast cancer
  • more about the side effects

Summary of results

The research team found that the combination of LCL161 and paclitaxel may be useful for some people with triple negative breast cancer. But that it did cause some side effects.
 
This trial was open for people to join between 2013 and 2014. The trial team presented the results at a conference in 2015. 
 
About this trial
This trial recruited 209 women who had been recently diagnosed with triple negative breast cancer. 
 
They were put into one of two treatment groups at random:
  • 103 women had paclitaxel
  • 106 women had paclitaxel and LCL161
Everyone taking part had treatment for 12 weeks, and then had an operation to remove their cancer. 
 
Results
The research team looked at how many people had no sign of cancer when they had their operation. Doctors call this a pathological complete response, or pCR.
 
They found that it was similar in both groups:
  • 17 out of 103 women (17%) who had paclitaxel 
  • 17 out of 106 women (16%) who had paclitaxel and LCL161
They then looked in more detail at women who had a specific combination of genes. This is called a gene expression signature. About 3 out of 10 women in each group had this genetic signature. 
 
The research team compared women who had this genetic signature with women who didn’t. As before, they looked at how many women had no signs of cancer when they had their operation.
 
For women who had the genetic signature it was:
  • less than 2 out of 10 women (17%) who had paclitaxel
  • nearly 4 out of 10 women (38%) who had paclitaxel and LCL161
And for women who didn’t have the genetic signature it was:
  • less than 2 out of 10 women (16%) who had paclitaxel
  • less than 1 out of 10 women (6%) who had paclitaxel and LCL161

Side effects
Some people taking part in this trial did have side effects. Many of them were mild or didn’t last long. But some people had more serious side effects including a high temperature or lung problems. 
 
Just under 2 out of 10 women (18%) who had paclitaxel and LCL161 had a high temperature (pyrexia), compared to just 1% of those who had paclitaxel.
 
About 1 out of 10 women (10%) who had paclitaxel and LCL161 had a lung infection (pneumonia), compared to 2% of those who had paclitaxel.
 
Just under 1 out of 10 women (9%) who had paclitaxel and LCL161 had inflammation of the lung (pneumonitis). No one who had paclitaxel alone had this.
 
More people who had paclitaxel and LCL161 also had less serious side effects including:
  • diarrhoea
  • extreme tiredness (fatigue)
  • a drop in white blood cells
About 7 out of 10 people in each group had hair loss.
 
There is more information about the side effects of paclitaxel in our Cancer Drugs section
 
Conclusion
The research team concluded that the combination of paclitaxel and LCL161 may be a useful treatment for people with triple negative breast cancer and a certain combination of genes. But it did cause some serious side effects at the dose used in this trial.
 
Where this information comes from
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) but may not have been published in a medical journal.  The figures we quote above were provided by the research team. 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 Peter Schmid

Supported by

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

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Last review date

CRUK internal database number:

10178

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

Deborah wanted to help other breast cancer patients in the future

A picture of Deborah

“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."

Last reviewed:

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