1. Why are we doing this study?
Women with early breast cancer that has spread to 1 or 2 lymph glands will receive chemotherapy or endocrine therapy (hormone therapy), or both. These treatments are called adjuvant therapy.
We now know that these drug treatments are more advanced and very good at preventing the cancer from coming back. So the armpit treatment may no longer be needed.
If armpit treatment is no longer needed, it is important to know this. We could then spare women unnecessary treatment, and avoid the long term problems it causes.
2. Who can take part?
Not everyone who has breast cancer will be able to take part in this study. There is a list of criteria that determine whether you are suitable or not.
There is a good chance you will qualify if:
- you are over 18 years old
- have breast cancer that has spread to one or two lymph glands
- are suitable for axillary (armpit) treatment.
All women in the trial will have adjuvant treatment which, according to local guidelines, will include chemotherapy and/or endocrine therapy.
Depending on your personal circumstances you may also receive radiotherapy. You need to be able to receive adjuvant treatment to take part.
See the full list of inclusion and exclusion criteria on page 14 of the Trial Protocol document.
Your doctor will be able to discuss with you if you are eligible for this trial.
3. What will happen if you take part?
You will fill in a consent form and short questionnaires. Once you have registered you will be randomly placed into one of two groups. Both groups of patients will have all the treatment a patient not part of this trial would receive, the only exception is that one group will not receive the armpit treatment.
There won’t be a need for any extra tests or procedures.
You will be followed up at regular intervals for 5 years. During the routine follow-up care you will be asked to fill out questionnaires, focusing on your quality of life, problems in arm and hand, and any feelings of anxiety you may have. These questionnaires are quite short and extremely important for the study.
4. Who is running this study?
The study is being led by Dr Amit Goyal from the Royal Derby Hospital, and is being co-ordinated by the Nottingham Clinical Trials Unit
at the University of Nottingham and Sussex Health Outcomes Research & Education in Cancer at the University of Sussex. The study is funded by the National Institute for Health Research’s Health Technology Assessment Programme.