A study of taselisib and palbociclib for breast cancer (PIPA)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Breast cancer

Status:

Closed

Phase:

Phase 1

This study is looking at taselisib and palbociclib for breast cancer with a change (mutation) in a gene called PIK3CA that has stopped responding to treatment. It is for women whose cancer has spread to another part of their body. 

It is also open to people who have another type of solid tumour Open a glossary item that has spread. 

More about this trial

Hormone therapy is used to treat oestrogen receptor positive Open a glossary item breast cancer (ER positive). Letrozole and fulvestrant are 2 hormone treatments. They are used for women with ER positive breast cancer who have gone through the menopause (post menopausal).    

A common gene change (mutation Open a glossary item) in ER positive breast cancer is in the PIK3CA gene. This helps the cancer cells to grow. 

Taselisib is a targeted cancer drug called a cancer growth blocker. It works by stopping the signals of the PIK3CA gene.

Palbociclib is also a cancer growth blocker. It works by stopping a protein that cells need to divide and grow. 

In this study researchers are looking at giving taselisib and palbociclib as a combination and also with letrozole and fulvestrant,  

They are also looking at whether giving taselisib and palbociclib might help people with a solid tumour that has spread elsewhere in the body and whose: 

  • cancer has got worse despite having chemotherapy
  • cancer has a change in the PIK3CA gene

The aims of this study are to find:

  • the highest safe dose of taselisib and palbociclib to give
  • how safe taselisib and palbociclib is to give with fulvestrant
  • how safe taselisib and palbociclib is to give with letrozole
  • what the side effects are of these combinations
  • what happens to taselisib and palbociclib in the body

Who can enter

The following bullet points list the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.

There are 2 parts to this study, A and B. 

You may be able to join part A of this study you are in 1 of the following situations. You:

  • Have a solid tumour Open a glossary item that has spread and stopped responding to standard treatment Open a glossary item or there is no effective standard treatment
  • Have breast cancer that is oestrogen receptor positive Open a glossary item, has spread and continued to get worse while taking hormone therapy or chemotherapy 
  • Have breast cancer that has a change (mutation Open a glossary item) in the PIK3CA gene, has spread and continued to get worse while taking hormone therapy
  • Have breast cancer that has spread and stopped responding to standard treatment

Please note Part A is now closed to recruitment. 

You may be able to join part B if you are in 1 of the following situations. You:

  • Have a solid tumour that has spread and got worse while having chemotherapy and has a change (mutation) in the PIK3CA gene
  • Have breast cancer that has spread, and the cancer has a change (mutation) in the PIK3CA gene

And for both parts all of following apply. You: 

  • Have an area of cancer that can be measured
  • Are able to do most things apart from heavy physical work (performance status 0 or 1)
  • Have satisfactory blood test results
  • Are a woman who has gone through the menopause Open a glossary item (post menopausal) or have had both your ovaries removed (oophorectomy) or your ovaries don’t work. Women who haven’t gone through the menopause must have started goserelin Open a glossary item or a similar hormone therapy (LH blocker Open a glossary item) 4 weeks before starting the study treatment  
  • Are willing to use reliable contraception 4 weeks before starting treatment, during treatment and for 6 months afterwards if there is any chance you or your partner could become pregnant
  • Are at least 18 years old 

You cannot join this study if any of these apply. 

Cancer related

  • You have cancer that has spread to the brain or spinal cord that hasn’t been treated, is getting worse or you take steroids to control symptoms. You may be able to join if have had treatment, have had a scan that shows it helped, the cancer spread has not got any worse in the past month, you are not taking steroids and have another area of cancer that is measurable
  • You have had treatment in the past 4 weeks (6 weeks for nitrosoureas Open a glossary item and mitomycin C Open a glossary item) apart from hormone therapy (LH blockers) for men with castrate resistant prostate cancer, radiotherapy for cancer spread to the bones or other treatments such as bisphosphonates Open a glossary item for cancer spread to the bones
  • You have ongoing side effects from previous treatment apart from hair loss 

Medical conditions

  • You have problems with how your body breaks down and absorbs sugar
  • You have a condition such as Crohn’s disease or ulcerative colitis that affects how your digestive system Open a glossary item absorbs tablets
  • You are not able to swallow tablets or are unwilling to take tablets
  • You are not able to have injections into the muscle or are not willing to have them
  • You have major surgery in the month before starting treatment
  • You have high blood pressure that isn’t controlled by medication
  • You have had unstable angina, a stroke or heart attack in the past 6 months
  • You take medication for an abnormal heart rhythm 
  • You have liver disease such as cirrhosis or liver problems caused by alcohol 
  • You have HIV, hepatitis C or hepatitis B
  • You are taking steroids apart from inhalers
  • You are taking other medications that affect how your immune system Open a glossary item works
  • You have had a bone marrow transplant Open a glossary item 
  • You have had radiotherapy to a quarter (25%) or more of your bone marrow Open a glossary item in the last 2 months
  • You have another cancer apart from in situ carcinoma of the cervix and non melanoma skin cancer Open a glossary item. You may be able to join if you had treatment to cure the cancer, there hasn’t been any sign of cancer for at least 3 years and your doctor thinks you are at a low risk of the cancer coming back
  • You have another medical or mental health condition that the trial team think could affect you taking part

Other 

  • You have had drugs that block the mTOR protein Open a glossary item apart from everolimus 
  • You have had drugs that work in a similar way to taselisib and palbociclib
  • You are taking an experimental drug as part of another clinical trial or intend to do so
  • You are pregnant or breastfeeding

Trial design

This is a phase 1 study. 

Before you agree to take part in the study the team need to know that your cancer has a change (mutation) in the PIK3CA gene. You need to have a blood test so they can look for this. You won’t be able to take part if your cancer doesn’t have the gene change. This is called pre screening.

There are 2 parts to this study. Part A is now closed. 

In part A, researchers found the highest safe dose of palbociclib to give with taselisib. They are now using this dose in part B.

In part B there are 3 groups. Which group you are in depends if your breast cancer:

  • has the PIK3CA gene change
  • is oestrogen receptor positive or negative
  • is HER 2 positive or negative

People with another type of solid tumour are in group B2 only. 

Everyone has palbociclib and taselisib. 

Palbociclib is a tablet you take with food every day for 3 weeks. You then have a week of not taking it. Each 4 week period is called a cycle of treatment

Taselisib is a tablet you take every day. 

Group B1
The team need 25 people to join this group. You have fulvestrant, palbociclib and taselisib.

Fulvestrant is an injection you have in the muscle. You have it on day 1 and day 15 of the 1st cycle of treatment. You then have it every 4 weeks at the start of each cycle of treatment. 

You take the palbociclib tablet every day for 3 weeks, then have a week of not taking it.

You take the taselisib tablet every day.

Group B2
The team need 38 people to join this group. You have palbociclib and taselisib. 

You take the palbociclib tablet every day for 3 weeks, then have a week of not taking it.

You take the taselisib tablet every day.

Group B3
The team need 6 people to join this group. You have letrozole, palbociclib and taselisib.

Letrozole is a tablet you take every day. 

You take the palbociclib tablet every day for 3 weeks, then have a week of not taking it.

You take the taselisib tablet every day.

You continue treatment as long as it is helping and the side effects aren’t too bad.

Samples
When you agree to take part the researchers will ask for a sample of your cancer that was removed when you had surgery or a biopsy Open a glossary item.

They will also ask for some extra blood samples and biopsies during the study. You don’t have to agree to these if you don’t want to. You can still take part in the study.

Researchers will use these samples to see how well the treatment is working and to find what happens to palbociclib and taselisib in the body.

Hospital visits

You see the doctor to have some tests before taking part. These tests include: 

  • a physical examination
  • blood tests
  • heart scan (ECHO Open a glossary item or MUGA Open a glossary item)
  • heart trace (ECG Open a glossary item)
  • urine test
  • CT scan or an MRI scan

During treatment you see the doctor once a week for 8 weeks to have:

  • a physical examination
  • blood tests 
  • a heart trace

You then see the doctor every 4 weeks for:

  • a physical examination
  • blood tests 
  • a heart trace 
  • a urine test

You have a CT scan or MRI scan every 8 weeks for 6 cycles of treatment and then every 3 months.

You see the doctor when you finish treatment for the same tests you had at the beginning.

After treatment you see the doctor every month if you have side effects from the treatment until they resolve.

Side effects

The most common side effects of palbociclib are:

The most common side effects of taselisib are:

  • diarrhoea
  • inflammation of your large bowel (colitis)
  • high levels of sugar in the blood 
  • feeling or being sick
  • tiredness
  • loss of appetite
  • rash, itchy skin
  • sore mouth
  • change to the way the liver works
  • inflammation of the lungs (pneumonitis)

We have information on the side effects of fulvestrant and letrozole.

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 Nick Turner

Supported by

Experimental Cancer Medicine Centre (ECMC)
Institute of Cancer Research (ICR)
Pfizer
Roche
The Royal Marsden NHS Foundation Trust

Freephone 0808 800 4040

Last review date

CRUK internal database number:

14045

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

Harriet wanted to try new treatments

Picture of Harriet

“I was keen to go on a clinical trial. I wanted to try new cancer treatments and hopefully help future generations.”

Last reviewed:

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