A trial looking at 2 new tests to help select chemotherapy before surgery for breast cancer (ROSCO)

Cancer type:

Breast cancer

Status:

Open

Phase:

Phase 3

This trial is looking at 2 tests called CEP17 and TOP2A to help doctors decide the best type of chemotherapy to give before surgery for invasive breast cancer. This trial is supported by Cancer Research UK.

More about this trial

Doctors often give chemotherapy first to help shrink tumours before surgery for breast cancer. If you have invasive breast cancer you might be offered a combination of drugs that includes a taxane Open a glossary item such as docetaxel (also called Taxotere). Or you might have combination that includes an anthracycline Open a glossary item such as epirubicin.

At the moment, doctors usually give both drugs one after the other. These drugs work in different ways to kill cancer cells. For some people epirubicin works well and for other people docetaxel works well. But doctors aren’t sure which drugs work best for which people. All  drugs have side effects and doctors don’t want to give drugs that people don’t need.

In this trial, researchers are looking at 2 new tests. The tests are called CEP17 and TOP2A. They may help doctors to work out who benefits most from having epirubicin or who would benefit from having docetaxel.

The aims of the trial are to find out

  • How well the tests work in showing who will benefit from having a taxane and who will benefit from having an anthracycline
  • More about quality of life Open a glossary item

Who can enter

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

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

  • If you have one tumour,
         o It measures more than 20mm across or
         o It is any size and has spread into the skin, chest wall or both or
         o It is an inflammatory breast cancer tumour (a cancer in which the overlying skin is red, swollen painful to the touch)
  • If you have more than 1 tumour, the total measured areas of the tumours are at least 20mm
  • If you have cancer spread to the glands under the arm (axilla), a tissue sample (biopsy Open a glossary item) confirms the cancer has spread to lymph nodes under the arms or the lymph nodes

As well as the above, all of the following must apply.

  • You have invasive breast cancer
  • Your doctor thinks you are suitable to have chemotherapy before surgery
  • You are fit enough to have chemotherapy
  • The trial team can test a sample of tissue (biopsy Open a glossary item) you had taken before having chemotherapy
  • You are well enough to take part (performance status 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 that you or your partner could become pregnant
  • You are at least 18 years old

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

  • Have a tumour that is low or medium grade Open a glossary item and has receptors for the hormones oestrogen (is oestrogen receptor positive Open a glossary itemand progesterone receptor positive) Open a glossary item
  • Have had invasive breast cancer in the past
  • Have cancer that has spread to another part of the body
  • Have had chemotherapy
  • Have had a lot of radiotherapy to your bone marrow Open a glossary item
  • Have had hormone therapy before surgery unless you had it for less than 6 weeks
  • Are currently having chemotherapy, hormone therapy or any other treatment for breast cancer
  • Have had a heart attack in the last 6 months and you are HER 2 positive Open a glossary item
  • Have significant heart problems
  • Have high blood pressure that isn’t well controlled with medication
  • Have bleeding problems
  • Have an infection that isn’t getting better with medication
  • Have had another cancer in the last 5 years apart from successfully treated early cancers Open a glossary item or any other cancer that has been treated with the aim to cure and there hasn’t been any sign of it for at least 5 years
  • Have had a live vaccination Open a glossary item in the last month
  • Have any other medical condition or mental health problem that the trial team think would affect you taking part in this trial
  • Are pregnant or breastfeeding

Trial design

This is a phase 3 trial. The trial team need 1,056 people to take part.

To begin with, a sample of tissue you had taken when you had a biopsy will be sent to a specialist laboratory. They test the sample for both CEP17 and TOP2A. If, for some reason, the researchers can’t test your tissue sample for CEP 17 or TOP2A, you won’t be able to take part in the trial.

This 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.

  • One group have chemotherapy that includes a taxane drug
  • The other group have chemotherapy that includes an anthracycline drug

Everyone has chemotherapy followed by surgery.

Diagram for ROSCO

In this trial, the chemotherapy combination that includes a taxane drug is called TC. It includes 2 drugs called

  • Docetaxel (also called Taxotere)
  • Cyclophosphamide

The chemotherapy combination that includes epirubicin is called FEC. FEC includes 3 drugs called

  • 5-Fluorouracil (also known as 5 FU)
  • Epirubicin
  • Cyclophosphamide

You have either FEC or TC once every 3 weeks. Each 3 week period is called a cycle of treatment. You have treatment as a drip into a vein. You have up to 4 cycles of treatment to begin with.

If your cancer is HER2 positive Open a glossary item you also have trastuzumab alongside chemotherapy. This is usual treatment for people with HER2 positive breast cancer. You have it either as a drip into a vein or injections under the skin. You have it once every 3 weeks for up to 1 year.

After 4 cycles of treatment you have a scan. If it shows the cancer hasn’t shrunk very much, you may have a further 4 cycles of chemotherapy before surgery.

If it has shrunk enough, you have surgery. Doctors look at the tissue removed during the operation to see if there is any cancer left. If the cancer has completely disappeared, you may or may not have 2 more cycles of chemotherapy. This is up to you and your doctor to decide. If the cancer hasn’t completely disappeared, you have further chemotherapy after surgery.  If you had FEC initially you have TC. If you had TC initially you now have FEC.

The researchers are also doing a small sub study looking at test called a sentinel node biopsy.

It is usual to have an ultrasound scan to look at the lymph glands Open a glossary item (sometimes called lymph nodes) under your arm. If they look abnormal you have a biopsy. If there is cancer in the nodes, you have all the nodes under the arm removed during surgery. This is called an axillary dissection or axillary clearance.

The doctors can also check the lymph nodes during surgery using a sentinel node biopsy. But they don’t know if sentinel node biopsy is a reliable way of telling if the cancer has completely disappeared if it was in the nodes before you had chemotherapy. In this trial, doctors would like to do a sentinel node biopsy and an axillary clearance all at once during surgery. This will make the operation slightly longer.

This part of the trial is only open to people with cancer under their arm found before they start treatment. If you don’t want to take part in the sub study, you don’t have to. You can still take part in the trial.

The trial team will ask you to fill out a questionnaire before you start treatment and at set times during treatment and after you finish treatment. The questionnaire will ask about side effects and how you’ve been feeling. This is a quality of life study.

Hospital visits

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

You have your chemotherapy and surgery at the hospital. How long you stay in hospital after surgery depends on the type of operation you have. Your doctor can tell more about this.

You see the trial team

  • For a check up 6 weeks after surgery
  • Once a year for 5 years

Side effects

The most common side effect of chemotherapy drugs include

A common side effect of epirubicin is heart damage, but this usually happens with higher doses than the doses used in this trial.

The most common side effects of docetaxel are

  • Nerve damage such as numbness and tingling in your hands and feet (peripheral neuropathy)
  • Joint aches and muscle pain

We have more information on the side effects of

Location

Birmingham
Bournemouth
Coventry
Forth Valley
Gillingham
Glasgow
Kidderminster
Macclesfield
Norwich
Nottingham
Peterborough
Redditch
Sheffield
Stockton-on-Tees
Taunton
Truro
Worcester
Yeovil

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

Dr Daniel Rea

Supported by

Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
University of Birmingham

Other information

This is Cancer Research UK trial number CRUK/12/046.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

10560

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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