A trial looking at LCL161 and paclitaxel before surgery for triple negative 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 2

This trial is looking at a drug called LCL161 with paclitaxel (Taxol) for breast cancer that doesn’t have receptors for the hormones progesterone and oestrogen, or for the protein HER2. This is called triple negative breast cancer.

Some of the treatments that doctors often use for breast cancer, such as hormone therapy or Herceptin, don’t work for triple negative breast cancer. So if you need to have treatment before surgery (neoadjuvant treatment), you are most likely to have chemotherapy for this type of breast cancer. One chemotherapy drug doctors can use is paclitaxel.

If normal cells continue to grow and reproduce more than the body needs, signals are sent out for these cells to self destruct. This is called programmed cell death (apoptosis). Cancer cells don’t respond properly to these signals and so continue to grow and reproduce.

LCL161 is a drug that works by restoring the cancer cells’ ability to respond to the signals telling the cells to stop growing.

In this trial the researchers want to compare a combination of paclitaxel and LCL161 with paclitaxel alone. The aims of this trial are to find out

  • How well LCL161 with paclitaxel works for triple negative breast cancer
  • How safe it is

Who can enter

You may be able to enter this trial if you are a woman and

  • You have triple negative breast cancer that hasn’t spread to another part of your body apart from lymph nodes
  • You haven’t had treatment – if you have had treatment for breast cancer in your other breast and it was at least 2 years ago you may be able to take part
  • Your cancer is between 2 cm and 5 cm across (stage T2)
  • You are able to have surgery to remove your whole breast (mastectomy) or surgery to remove part of your breast
  • You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
  • You have satisfactory blood test results
  • You are willing to use reliable contraception during treatment and for 6 months afterwards if there is any chance you could become pregnant
  • You are at least 18 years old

You cannot enter this trial if

  • Your breast cancer has spread to another part of your body
  • You have cancer in both your breasts
  • You have inflammatory breast cancer
  • Your cancer has spread to the lymph nodes Open a glossary item surrounding your collar bone, in your arm pit or behind your breast bone
  • You have another cancer and are having treatment that affects your whole body (systemic treatment Open a glossary item) or have had systemic treatment in the past 3 months
  • You have had a heart attack or heart pain (angina) in the past 3 months or have any other serious heart problem
  • You have been having steroids for more than 3 months apart from inhalers and creams
  • You are taking any medication that affects your immune system
  • You have a problem with your digestive system Open a glossary item that means you can’t absorb capsules
  • You have any other medical condition that could affect you taking part in this trial
  • You are taking medication that affects body proteins called cytochrome P enzymes – your doctor can confirm this
  • You are allergic to taxane chemotherapy drugs (paclitaxel or docetaxel)
  • You are allergic to a type of castor oil called Cremophor EL
  • You are pregnant or breastfeeding

Trial design

The researchers will ask for a sample of your cancer taken when your cancer was diagnosed. If this isn’t available they will take a fresh sample (biopsy Open a glossary item). The researchers will use this to test for gene changes that show LCL161 is likely to help you. You must agree to have this biopsy to be able to take part in the trial. But if the tests show that you don’t have any of the gene changes, you can still take part.

This is an international phase 2 trial. It will recruit 200 women from different countries around the world. It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. The 2 groups in this trial are

  • LCL161 and paclitaxel
  • Paclitaxel alone

trial diagram

You have paclitaxel through a drip into a vein. LCL161 is a capsule that you swallow. You take 6 capsules immediately after you have paclitaxel.

You continue to have treatment every week for 3 months as long as it is helping you and the side effects aren’t too bad.

After you finish treatment, your doctor will talk to you about the possibility of having surgery to remove your cancer within a month.

If you aren’t able to have surgery within the month, the researchers will ask for a small sample of tissue (biopsy). Your doctor will also talk to you about what other treatments may be available.

The researchers will get samples of your cancer tissue before you start treatment, and during treatment. They will use these to look for substances in the tissue that may show how well the treatment is working (biomarkers Open a glossary item).

For people having LCL161 with paclitaxel, the researchers will also take some extra blood samples. They will use these to find out what happens to LCL161 in your body, how well it works and what effect it has on your body.

Hospital visits

You see the doctor to have some tests before taking part in this trial. These tests include

You have paclitaxel every week but during treatment you see the doctor every 3 weeks for a physical examination and blood tests.

At the end of treatment, you see the doctor to talk about whether or not you can have surgery to remove your cancer. You see the doctor again 6 weeks later.

Side effects

LCL161 is a new drug and there may be side effects we don’t know about yet. The side effects may include

LCL161 may also make your skin more sensitive to ultraviolet light. So you must take care to limit your exposure to the sun and other forms of ultraviolet light.

The most common side effects of paclitaxel are

We have more information about paclitaxel in our cancer drugs section.

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)
National Institute for Health Research Cancer Research Network (NCRN)

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 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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