A trial of palbociclib and hormone therapy before surgery to remove breast cancer (NEO12-RS)

Cancer type:

Breast cancer

Status:

Open

Phase:

Phase 2

This trial is looking at palbociclib and hormone therapy for women who are newly diagnosed with breast cancer. 

And whose cancer has receptors for the hormone oestrogen (ER positive Open a glossary item) but doesn’t have receptors for HER2 Open a glossary item(HER2 negative).

Cancer Research UK supports this trial. 

More about this trial

You can have hormone therapy or chemotherapy to reduce the size of the cancer before you have surgery to remove it. Doctors call this neoadjuvant treatment. 

In this trial researchers want to add palbociclib to hormone treatment before you have surgery. 

Palbociclib is a targeted drug  Open a glossary itemcalled a growth blocker. It works by blocking 2 proteins that stimulate cancer cells to grow. The aim is to slow or stop the growth. 

In this trial researchers are using the hormone therapies such as letrozole and goserelin. You have:

  • letrozole on its own if you have gone through the menopause Open a glossary item or
  • letrozole and goserelin if you haven’t gone through the menopause 

As part of the trial you have a test called Oncotype DX Recurrence Score. This test looks at the chances (risk) of your cancer coming back after treatment. This is either:

  • a high chance (high risk)
  • an in between chance (intermediate risk)
  • a low chance (low risk)

Your treatment in the trial depends on what your risk is. 

Researchers will compare palbociclib and hormone therapy with hormone therapy on its own. The aim is to find out:

  • how well palbociclib and hormone therapy works
  • what the side effects are 

Who can enter

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

Who can take part

You may be able to join this trial if all of the following apply. You:

  • have breast cancer that has grown into the surrounding tissue (invasive breast cancer
  • have cancer that has many oestrogen receptors (ER positive)
  • have cancer that doesn’t have many HER2 receptors (HER2 negative) 
  • have cancer that measures 15mm or more across and has not spread to the lymph nodes or you have a cancer that is any size and has spread to the lymph nodes
  • can have hormone therapy or chemotherapy before surgery or radiotherapy (neoadjuvant treatment)
  • are up and about for at least half the day and can look after yourself but might not be able to work (performance status 0, 1 or 2)
  • have satisfactory blood test results
  • are at least 18 years old

Who can’t take part

You cannot join this trial if any of these apply. You:

  • have inflammatory breast cancer
  • have had surgery to find out if the cancer had spread to the lymph nodes in your armpit unless you had a fine needle aspiration  Open a glossary item(FNA) or a core needle biopsy Open a glossary item to find out
  • have cancer that has spread to another part of the body unless it had happened after having the Oncotype DX Recurrence Score test for this trial
  • have had another cancer in the past 5 years apart from successfully treated non melanoma skin cancer Open a glossary item and carcinoma in situ Open a glossary item of the cervix
  • have already had hormone therapy or chemotherapy for your breast cancer
  • are taking hormone replacement therapy Open a glossary item (HRT) or any other medication or supplement containing oestrogen Open a glossary item such as vaginal oestrogen or phytoestrogen within 4 weeks of joining this trial
  • are taking medication or supplements that affect the CYP enzymes
  • have an active infection that isn’t controlled by medication
  • have a problem with bleeding
  • have any other medical condition or mental health problem that your doctor or the trial team think can affect you taking part
  • are pregnant or breastfeeding

Trial design

This is a phase 2 trial. The trial team need 118 people to join with 58 people in the intermediate risk group and 80 people in the high and low risk group.

Everyone has the Oncotype DX Recurrence Score test. The results can take up to 2 weeks to come back. The results will show how likely it is for your cancer to come back after treatment. This is either:

  • very likely (high risk) or
  • in between (intermediate risk) or
  • not very likely (low risk) 

There are 2 parts to this trial. Which part you are in depends on your risk. 

High risk and low risk
This is the observational group. You have the usual treatment before surgery. What the treatment is depends on your risk and whether you have gone through the menopause or not. 

Women who have a low risk and have gone through the menopause have hormone treatment such as letrozole. 

Women who have a low risk and haven’t gone through the menopause have letrozole and goserelin. 

Women at high risk have chemotherapy whether they have gone through the menopause or not. You doctor decides which chemotherapy you have. 

Intermediate risk
This part is a randomised trial. You have either standard treatment or the trial treatment before surgery. Neither you nor your doctor chooses which treatment you have. 

The treatment you have in each group also depends on whether you have gone through the menopause or not. 

Women who are in the standard treatment group have either:

  • letrozole if you have gone through the menopause or
  • letrozole and goserelin if you haven’t gone through the menopause

Women in the trial treatment group have either:

  • palbociclib and letrozole if you have gone through the menopause or
  • palbociclib, letrozole and goserelin if you haven’t gone through the menopause

Palbociclib is a capsule you take once a day. You take it for 3 weeks and then have a week of not taking it. You swallow the capsule whole with a glass of water. You cannot crush it or chew it. You take it at the same time each day. It is best taken with food. 

You start on a certain dose. Your doctor can reduce the dose if are having certain side effects. 

Letrozole is a tablet you take once a day every day. 

You have goserelin as an injection under the skin of your tummy (abdomen). It is a depot injection, which means that the drug is slowly absorbed into your body over time. 

You have chemotherapy as a drip into a vein. You have your treatment in cycles Open a glossary item. How many cycles you have depends on what chemotherapy you have. Your doctor will tell you this. After chemotherapy you have surgery to remove your breast cancer.

You have treatment for 24 weeks and then have surgery to remove your cancer. 

Diary 
Women having palbociclib keep a diary of when you had your capsule. You also write down if you don’t take the capsule and the reason for not taking it. 

Research samples
You give several blood samples during the trial. 

They take a small piece of cancer tissue from the sample when you were diagnosed and a small piece of the cancer from when they remove it during surgery. 

For women in the intermediate group they’ll take another sample of tissue after 2 weeks of treatment and at the end of treatment. 

Hospital visits

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

  • a physical examination 
  • blood tests
  • a breast ultrasound
  • a breast examination 

Treatment visits for women with a low risk or high risk (observation group)
For women whose risk test shows you have a low risk you see the doctor every 4 weeks during treatment for a breast examination. 

For women who have a high risk how often you see the doctor during treatment depends on what chemotherapy you are having. At these visits you have a breast examination. 

Everyone has a breast ultrasound at 12 weeks. 

At the end of 24 weeks (end of trial) you see the doctor and have:

  • a breast examination
  • bloods 
  • a breast ultrasound

You have surgery and then see the doctor 4 weeks after. 

Treatment visits for intermediate risk women (randomised group) 

You see the doctor at 2 weeks for:

  • a breast needle (core) sample
  • bloods

You then see the doctor 2 weeks later and then every 4 weeks to see how you are doing and for:

  • a physical examination
  • a breast examination
  • blood tests

Your doctor will also ask you about any side effects and to look at your diary. 

You have a breast ultrasound at 12 weeks.

At the end of 24 weeks (end of trial) you see the doctor for:

  • a physical examination
  • a breast examination 
  • a breast ultrasound
  • blood test
  • a breast needle (core) sample

Your doctor will ask you again about any side effects and to look at your diary. 

You have surgery and then see the doctor 4 weeks after. 
 

Side effects

The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better. 

The most common side effects of palbociclib are:

We have information about:

You doctor or a member of the trial will tell you about the possible side effects of the treatments in this trial before you agree to take part. 

Location

Huddersfield
Liverpool
Newcastle upon Tyne
Nottingham

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 Carlo Palmieri

Supported by

Cancer Research UK
Pfizer
University of Liverpool

Freephone 0808 800 4040

Last review date

CRUK internal database number:

16745

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

Caroline took part in a clinical trial for breast cancer

“I had treatment last year and I want to give something back.”

Last reviewed:

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