“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."
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.
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 nodessurrounding 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) 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 systemthat 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
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 (
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
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 (
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.
You see the doctor to have some tests before taking part in this trial. These tests include
- Biopsy (if needed)
- Physical examination
- Blood tests
- Urine test
- Chest X-ray
- CT scan or MRI scan
- Breast ultrasound
- Heart trace (
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.
LCL161 is a new drug and there may be side effects we don’t know about yet. The side effects may include
- High temperature (fever)
- Skin rash or reddening of the skin (flushing)
- Feeling or being sick
- Feeling weak
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
- An allergic reaction while having the drug
- Tummy upset
- Hair loss
- Slowing down of your heart rate
- Low blood pressure
- A drop in blood cells causing an increased risk of infection, shortness of breath and tiredness
- Joint and muscle pain
- Sore mouth and lips
- Inflammation around the drip site
- Numbness, tingling or burning in your hands or feet
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.
Professor Peter Schmid
Experimental Cancer Medicine Centre (ECMC)
National Institute for Health Research Cancer Research Network (NCRN)