“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."
A trial looking at chemotherapy after surgery for breast cancer (TACT 2)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is comparing 2 weekly with 3 weekly epirubicin combined with either CMF chemotherapy or capecitabine, after surgery for breast cancer. This trial is supported by Cancer Research UK.
Doctors sometimes treat early breast cancer with chemotherapy after surgery. Cyclophosphamide, methotrexate, 5FU and epirubicin are drugs commonly used. Doctors think that giving another drug called capecitabine might be useful but they are not sure.
This trial is comparing giving these drugs in certain combinations either every 2 or every 3 weeks, to see which is better at treating early breast cancer. And to find out more about the side effects.
Who can enter
You can enter this trial if you
- Have early breast cancer that needs chemotherapy treatment
- Have had surgery to remove your breast cancer within the last 8 weeks
- Are well enough to have chemotherapy (performance status 0, or 1)
- Have satisfactory blood test results
- Are at least 18 years old
- Are willing to use reliable contraception while you are taking part in the trial if there is any chance you or your partner could become pregnant
You cannot enter this trial if you
- Have not yet had any treatment for your breast cancer
- Have had previous breast cancer (except DCIS or LCIS that was removed with surgery)
- Have stage 3 or 4 breast cancer
- Have had chemotherapy or radiotherapy before, except radiotherapy for non melanoma skin cancer
- Have had more than 6 weeks of hormone therapy before your breast cancer surgery (you must have stopped any hormone therapy at least 1 month before joining the trial)
- Have, or have had any other cancer in the last 10 years, apart from carcinoma in situ of the cervix or non melanoma skin cancer or DCIS that was treated successfully
- Have any other serious medical condition
- Have heart or kidney problems
- Are HIV, hepatitis B or hepatitis C positive
- Have an infection and are taking antibiotics
- Are pregnant or breastfeeding
This is a phase 3 trial. It aims to recruit about 4,400 people. The trial is randomised. If you take part you will be put into one of 4 different treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.
If you are in group 1, you will have epirubicin. You will have this drug into your vein through a drip. This takes about an hour each time. You have this on day 1 of your 3 week treatment cycle. Each 3 week period is one cycle of chemotherapy. You will have 4 cycles of this.
Next you will have 4 cycles of another chemotherapy combination, each cycle over 4 weeks. This will be cyclophosphamide either as a tablet to swallow every day for 14 days, or through a drip on day 1 and day 8 of your 28 day treatment cycle. You will also have methotrexate and 5FU on days 1 and 8 of your treatment cycle. You will have 8 cycles in all, so your treatment will last for about 6 months.
If you are in group 2, you will have epirubicin. You will have this drug into your vein through a drip. You will have this drug on day 1 of each 2 week treatment cycle. You will have 4 treatment cycles. You will also have a single dose of G-CSF as an injection under the skin on the day after each dose of epirubicin.
G-CSF is a growth factor that stimulates white blood cells to grow. Some chemotherapy drugs used can cause a drop in the number of white blood cells. Giving G-CSF after each dose of chemotherapy may prevent the white blood cell count falling so far. The aim of this is to reduce the risk of infection, and to give the full dose of chemotherapy each time.
As for group 1, after 4 cycles of epirubicin, you will then have cyclophosphamide, methotrexate and 5FU every 28 days. Each 4 week period is one cycle and you will have 4 cycles of this making 8 treatment cycles in all. Your treatment will last about 6 months.
Group 3 will have epirubicin every 3 weeks for 4 cycles. Then you will have another chemotherapy drug called capecitabine. You will have this as tablets to swallow for 14 days every 3 weeks for 4 cycles in all.
If you are in group 4, you will have epirubicin every 2 weeks for 4 cycles. You will also have a single dose of G-CSF a day after having each dose of epirubicin as in group 2. After this treatment, you will then have capecitabine the same as for group 3. Both Group 3 and Group 4 will have treatment that will last for about 6 months.
Your doctor may decide that you should also have a course of radiotherapy to treat your breast cancer. This applies to women in all 4 groups, but will depend on your individual situation. If you do have radiotherapy, you will start treatment after you finish your course of chemotherapy.
You will need to go to the hospital to have some tests before you can take part in this trial. These tests include
- A chest X-ray
- Blood tests
You may be asked to have
You will have blood tests and check ups throughout your treatment. Whichever group you are in, you will have your treatment as a day patient. You will probably spend at least half a day at the hospital each time.
After your treatment has finished you will see your doctor every 6 months over the next 2 years, then yearly after that for about 5 years. Your doctor will ask how you are, examine you and may arrange for you to have other tests, such as blood tests.
You may also be asked to fill out a questionnaire during your treatment. This will ask you how you have been feeling. It is called a 'Quality of Life' study.
All treatments have side effects. The most common side effects of the chemotherapy drugs in this trial are
- A drop in blood cells causing an increased risk of infection, bleeding or bruising, shortness of breath and tiredness
- Feeling sick
- Hair loss
- Loss of fertility
- Loss of appetite
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.
Professor David Cameron
Professor Judith Bliss
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
This is Cancer Research UK trial number CRUK/05/019.