OPTIMA

 Breast Cancer / Posted 1 year ago

OPTIMA: A trial looking at a test to predict who might benefit from chemotherapy for breast cancer

Chemotherapy and hormone treatment are currently offered to many people as part of their breast cancer treatment. This is to reduce the chance of the cancer coming back. Chemotherapy is given as an injection, usually every three weeks over a few months. Hormone therapy is a daily tablet taken for five to ten years. Younger women may also have a monthly injection to stop menstrual periods.

Recently however it has been argued that chemotherapy may have little effect on the subtype of breast cancer that is broadly identified as being hormonally responsive without HER2 gene amplification/HER2 protein overexpression and with a low or intermediate grade. Recent research indicates that some people with this subtype of breast cancer may not benefit from chemotherapy, and would do just as well with hormone treatment alone.

The decision to offer chemotherapy, or not, is currently made using simple measurements such as the size of the tumour and the number of lymph nodes affected. These methods are not as good as we would like, which means that some patients may be given chemotherapy unnecessarily.

Tests have been developed to try to predict which people could avoid chemotherapy. The tests are performed on a sample of the tumour removed by the surgeon. There are several of these tests. More research is needed into how best to use all of these tests.

The aim of this study is to investigate whether a personalised decision about chemotherapy using these new tests can be made safely and effectively.

Everyone who takes part in this study will receive hormone therapy. Only some people who take part in this study will receive chemotherapy.

  • Inclusion Criteria : You may be able to enter this trial if your breast cancer:
    • Had grown into the surrounding healthy tissue (invasive breast cancer)
    • Has been removed with surgery And you are in one of the following situations
    • 1 to 9 lymph nodes under your arm have cancer in them. If your cancer has spread to only 1 to 3 lymph nodes, at least in 1 node the spread is greater than 2mm across
    • Your cancer measured more than 20mm, it has spread to 1 to 3 lymph nodes and is less than 2mm across in each node
    • Your cancer measured 30mm or more but had not spread to the lymph nodes And all of the following apply:
    • Your cancer is oestrogen receptor positive
    • Your cancer is HER 2 negative
    • You are able to have chemotherapy after your surgery
    • You are at least 40 years old
  • Exclusion Criteria :
    • Your cancer has spread to 10 or more lymph nodes under your arm
    • Your cancer has spread to another part of the body (metastatic)
    • You have already had treatment for breast cancer before surgery - you might be able to join the trial if you had hormone treatment before surgery and the treatment had stopped more than a year ago
    • You have already had further treatment after surgery apart from hormone treatment for a short time afterwards
    • It has been more than 12 weeks after your surgery
    • Your doctor has planned further breast cancer surgery unless it is an operation to remove the breast completely (mastectomy) or some more breast tissue after you have had chemotherapy
    • You were taking hormone replacement therapy (HRT) when you had your surgery - you may take part if you stopped taking HRT before surgery
    • You have had another cancer apart from basal cell skin cancer , cervical intraepithelial neoplasia (CIN ), lobular carcinoma in situ (LCIS), lobular neoplasia of the breast, ductal carcinoma in situ (DCIS ) that has been treated with radiotherapy or removed by surgery, or any other cancer that was removed with surgery and there has been no sign of it for at least 10 years
    • You have any other medical or mental health problem that your doctors think could affect you taking part in the trial
  • Study start date : 16/01/2017
  • Study end date : 31/12/2021
  • Wales-Based Study Contact : please speak to your clinician
  • Principal Investigator : Dr Rob Stein

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