Who can take part?
You may be able to take part in the OPTIMA study if you are a women or man aged 40 or over, are able to have chemotherapy and have a breast cancer that:
- has grown into the surrounding healthy tissue, known as ‘invasive breast cancer’
- has been removed with surgery
- is hormone sensitive (With hormone sensitive cancers, the cancer relies on hormones to grow. In breast cancer the relevant hormones are oestrogen and progesterone. OPTIMA is for hormone sensitive cancers that are ‘Oestrogen receptor positive, referred to as (ER+))
- is HER2 negative. HER2 is a protein found on some breast cancers. OPTIMA is not for cancers that have a higher than normal level of HER2.
And who are in one of the following situations:
- The cancer has spread to 1-9 lymph nodes under the arm. If the amount of cancer in the lymph node is very small (less than 2mm) then the breast cancer must be at least 2cm in size
- The cancer has not spread to the lymph nodes but is at least 3cm in size
- If your cancer is affecting both breasts you may still be able to take part. Please discuss your circumstances with your breast team and / or oncology team
You can have taken hormone therapy for up to 8 weeks before surgery. Hormone therapy uses medicines to block or lower the amounts of hormones in the body. Hormone therapy is intended to slow down or stop the growth of cancer.
You can have taken other drugs along with the hormone therapy as part of a clinical trial.
You can also have taken hormone therapy after surgery so long as you stop at the point of joining OPTIMA.
You cannot join OPTIMA if any of these apply:
- Your cancer has spread to 10 or more lymph nodes under your arm
- Your cancer has spread to another part of the body. Referred to as metastatic or secondary breast cancer
- You have already been treated with chemotherapy or radiotherapy for your breast cancer
- It has been more than 12 weeks since your surgery
- Your doctor has not finished your breast cancer surgery. You can join however, if your doctor has planned an operation to remove the breast completely (mastectomy) or some more breast tissue after a few months
- You were taking hormone replacement therapy (HRT) at the time of your breast surgery. You can, however, have taken HRT before your surgery
- You have taken some other hormonal drugs in the last year – please discuss with your surgeon / oncologist. An exception is hormonal drugs given as part of fertility treatment or as contraception
- You were previously treated for another cancer, unless:
- The only treatment was surgery (with or without radiotherapy) and there has been no sign of the cancer for at least 10 years
- The cancer was a basal cell carcinoma. Basal cell carcinoma is a common type of skin cancer
- The treatment was for pre-cancerous changes in the cervix.
- You have been treated in the past with a hormonal drug like tamoxifen for abnormal pre-cancerous cells in the breast called “lobular carcinoma in situ (LCIS)” or “ductal carcinoma in situ (DCIS)”. You can still take part if you just had surgery and radiotherapy for LCIS or DCIS. (LCIS refers to cell changes in the lining of the breast lobes which increases the risk of getting breast cancer in the future. DCIS is where cells in the milk ducts of the breast have started to turn into cancer cells. The cells have not spread into surrounding breast tissue or elsewhere in the body).