A study looking at ultrasound guided biopsies for breast cancer (NOSTRA)
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:
Other
This study is for people with early breast cancer that:
- have large amounts of a protein called human epidermal growth factor receptor (HER2 positive)
- don’t have receptors for the hormone oestrogen (oestrogen receptor negative or ER negative)
It is for people who are going to have a cancer drug treatment before surgery.
More about this trial
For early breast cancer, you usually have a drug treatment before surgery. This treatment can shrink the cancer and make surgery more successful. This is called neoadjuvant treatment.
Neoadjuvant treatment is usually a combination of chemotherapy and targeted drugs. Common treatment combinations include:
- a combination of chemotherapy drugs called FEC with pertuzumab (Perjeta) and trastuzumab (Herceptin). You then have docetaxel with pertuzumab and trastuzumab
- FEC and then docetaxel with pertuzumab and trastuzumab
- docetaxel and carboplatin, and then pertuzumab and trastuzumab
After neoadjuvant treatment, you have breast cancer surgery. But sometimes, the neoadjuvant treatment kills all the cancer cells. So doctors would like to know, whether an ultrasound guided biopsy can tell who:
- still has cancer cells after neoadjuvant treatment (residual disease)
- doesn’t have cancer cells after neoadjuvant treatment (complete response)
Everyone taking part in this study has neoadjuvant treatment, followed by an ultrasound guided biopsy. You then have breast cancer surgery.
The main aim of this trial is to find out whether ultrasound guided biopsies can tell who still has cancer cells after neoadjuvant treatment. In the future, doctors hope to be able to tell who doesn’t need breast cancer surgery after neoadjuvant treatment.
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.
Your trial doctor and nurse will check that you meet all the entry conditions before you take part.
Who can take part
You may be able to join this trial if all of the following apply:
- you have invasive breast cancer
- your cancer has one of the following tumour (T) stages - T1c, T2, T3, T4a, T4b, T4c or T4d
- your cancer has large amounts of HER2 protein (HER 2 positive) and does not have receptors to the oestrogen hormone (ER negative)
- doctors think that you are well enough to have neoadjuvant treatment and surgery
- you have had a tissue sample of your cancer taken (biopsy)
- your heart, liver and kidneys are working well
- you have satisfactory blood tests results
- you are well enough to carry out your normal activities, apart from heavy physical work (performance status of 0 or 1)
- you are willing to use reliable contraception during treatment and for at least 6 months afterwards if there is any possibility that you could become pregnant
- you are at least 18 years old
Who can’t take part
You cannot join this study if any of these apply.
Cancer related
- you have had breast cancer on the same breast side or have any other cancer that needs treatment
- your cancer has spread to other parts of your body (metastatic)
- you have had chemotherapy
- you have had radiotherapy to a large area of your bone marrow
- you can’t have a combination of chemotherapy and targeted drugs, and breast cancer surgery for any reason
Medical conditions
You:
- have heart problems such as hypertension that isn’t controlled, your heart is unable to pump blood around the body properly, or you have narrowing of the heart blood vessels due to a build up of fat
- have a problem with the way your blood clots which causes a high risk of bleeding
- have any other serious medical condition or mental health problem that the trial team think could affect you taking part
- are pregnant or breastfeeding
- have had a live vaccine in the past 4 weeks
Trial design
This is a feasibility study. Doctors hope that around 150 people from the UK will agree to take part.
Everyone has neoadjuvant treatment with one of the following treatment combinations (regimens):
- FEC with pertuzumab and trastuzumab. You then have docetaxel with pertuzumab and trastuzumab
- FEC and then docetaxel (FEC-T) with pertuzumab and trastuzumab
- docetaxel and carboplatin, and then pertuzumab and trastuzumab
Your doctor can tell you which treatment combination you will have. This is the same as the standard treatment.
You usually have all drugs as a drip into your bloodstream (intravenously). You may also have trastuzumab as an injection under your skin (subcutaneous). It takes about 4 and a half months to have it.
After the neoadjuvant treatment, you have an ultrasound guided biopsy. You lie on a couch and your doctor puts an ultrasound probe over your skin. This finds the right place to take the sample.
The doctor then puts a local anaesthetic to numb the skin. Then they gently put a needle into your breast to take up to 8 samples of tissue.
You may also have samples of tissue taken from the lymph glands under your arm. This is common and part of your standard treatment.
You may also have samples of tissue taken from the lymph glands under your arm. This is common and part of your standard treatment.
About 4 to 8 weeks later, you have breast cancer surgery. This is the same as the standard treatment. Having the biopsy will not delay your operation.
Your doctor might remove:
- the whole of the breast (mastectomy)
- just the breast cancer (lumpectomy or breast conserving surgery)
- the lymph nodes under the arm (axillary clearance)
Your doctor can tell you what to expect during surgery. After the operation, you may continue to have trastuzumab on its own. This is also part of your standard treatment.
Blood tests (optional)
You may have extra blood tests as part of this study. Doctors want to look for cancer DNA in your blood. You have the extra blood tests before the start of treatment and then:
- after the first neoadjuvant treatment cycle
- after surgery
Hospital visits
You see a doctor and have some tests before taking part. These tests might include:
- a physical examination
- blood tests
- mammogram and a breast ultrasound
- heart ultrasound (echocardiogram or MUGA)
- CT scan
- bone scan
You see the doctor regularly during the neoadjuvant treatment. You have blood tests every 3 weeks to check how you are.
Your doctor can tell you what happens during breast cancer surgery.
After the operation, you continue to see your doctor as part of your standard treatment. The trial team will also see or speak with you after 1 and 5 years to check how you are.
Side effects
The trial team at your hospital monitor you during the biopsy and afterwards. You have a phone number to call them if you are worried about anything after you go home.
Biopsies are safe tests. The team will tell you about all the possible side effects before you have it. Possible side effects of having a biopsy include:
- pain at the site of the biopsy
- bruising and swelling of the breast
You might also have side effects from:
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 Daniel Rea
Supported by
Cancer Research UK
University of Birmingham
Roche
Other information
This is Cancer Research UK trial number: CRUKE/16/025.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
Last review date
CRUK internal database number:
15302
Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.
