A trial looking at having trastuzumab (Herceptin) with chemotherapy for early breast cancer (SOLD)

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

Cancer type:

Breast cancer




Phase 3

This trial is comparing trastuzumab (Herceptin) with chemotherapy, to having Herceptin with chemotherapy followed by Herceptin only. This trial is for women with early breast cancer that has tested positive for HER2 receptors. This trial is supported by Cancer Research UK.

Doctors often treat early breast cancer with surgery followed by chemotherapy. If the breast cancer has tested positive for HER2 receptors, the doctors will treat this with 1 year of Herceptin after chemotherapy.

The researchers think that having Herceptin and chemotherapy together may be just as good as having Herceptin after chemotherapy. The researchers also hope that the side effects of Herceptin will be less if people have it for a shorter period of time.

The aim of this trial is to compare having trastuzumab (Herceptin) with chemotherapy to the same treatment followed by continued Herceptin to one year.

Who can enter

You can enter this trial if

  • You have early breast cancer that is HER2 positive
  • There is a high risk your breast cancer could come back after treatment because your cancer is bigger than 5mm or it has spread to lymph nodes – your doctor can advise about this
  • You have satisfactory blood test results
  • You are fully active and able to do everything you normally do, apart from heavy physical work (performance status 0, 1)
  • You are willing to use reliable contraception if there is a chance that you could become pregnant
  • You are at least 18 years old

You cannot enter this trial if

  • You have inflammatory breast cancer
  • Your breast cancer has spread to another part of the body
  • Your breast cancer has not spread to lymph nodes (N0) and is between 6 and 10 mm across (stage T1b) and is slow growing (grade 1)
  • Your breast cancer has not been tested for hormone receptors or HER2 receptors
  • You had chemotherapy or hormone therapy before your surgery (this is called neoadjuvant therapy)
  • Your surgery to remove your breast cancer was more than 12 weeks ago
  • You have had other major surgery in the last 4 weeks or have not fully recovered
  • You have had medication as part of another clinical trial in the last 4 weeks
  • You have had any other cancer in the last 5 years apart from, basal cell skin cancer that has been successfully treated and carcinoma in situ of the cervix
  • You have a serious heart problem that is not controlled with medication
  • You have had a heart attack in the last year
  • Your heart does not work well enough - your doctor will test for this
  • You have an infection
  • You have fits (seizures) that are not controlled with medication
  • You have another serious medical condition that could affect you taking part in the trial
  • You are pregnant or breastfeeding

Trial design

This is a phase 3 trial. It will recruit about 3,000 people from many countries around the world. It is a randomised trial. The people taking part will be put into 1 of 2 treatment groups. Neither your doctor nor you can choose which group you are in.

If you are in group 1, you have

  • Docetaxel and Herceptin
  • Fluorouracil, epirubicin and cyclophosphamide (this is known as FEC)

If you are in group 2, you have

  • Docetaxel and Herceptin
  • FEC
  • Then more Herceptin, until you have had one a year of Herceptin treatment in total

You have the docetaxel and FEC every 3 weeks for 3 cycles of treatment.

You can have Herceptin every 3 weeks or every week. If you have it every 3 weeks, you have it at the same time as the docetaxel.

If you are in group 2 you continue to have your Herceptin, either weekly or 3 weekly, after your FEC.

You have all treatment through a drip into a vein.

After FEC you may have radiotherapy or hormone therapy. Your doctor will discuss this with you.

You will be asked to fill in a questionnaire

  • Before treatment
  • At weeks 7, 16, 19, 31, 43 and 61
  • 3 years after treatment

The questionnaire will ask you about any side effects you have and how you are feeling. This is called a quality of life questionnaire.

The researchers will ask your permission to get a sample of tissue from when you had your surgery and to take some extra blood samples each year. These samples will be stored safely and only used for research purposes. Studying these samples may help researchers learn more about how to treat breast cancer.

You can choose to give permission for the researchers to take these samples, or not. Your decision will not affect you taking part in the trial.

Hospital visits

You will see the doctor and have some tests before taking part in this trial. These tests include

  • A physical examination
  • Heart trace (ECG Open a glossary item)
  • Blood tests
  • Heart scan (echocardiogram Open a glossary item or MUGA Open a glossary item)
  • CT scan (if needed) or MRI scan
  • Bone scan (if needed)
  • Pregnancy test (if applicable)

While having docetaxel and FEC, you see the doctor every 3 weeks and have a physical examination and blood test.

After the end of treatment with FEC, you see the doctor at weeks 31, 43, 62 and have

  • A physical examination
  • Blood tests
  • A heart scan

You will see the doctor once a year for 7 years. During year 3 you will also have the tests above.

Side effects

The most common side effects of docetaxel, FEC and Herceptin can include

You can find more information about docetaxel, FEC and Herceptin on CancerHelp UK.

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 Judy fraser

Supported by

Cancer Research UK
Cancer Research UK Clinical Trials Unit
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
The Finnish Breast Cancer Group

Other information

This is Cancer Research UK trial number CRUKE/10/033.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 6063

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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