OPTIMA trial - Clinical trial • Breast Cancer Foundation NZ

OPTIMA trial

Early Breast Cancer clinical trials for ER+

Recruiting
Updated: August 26, 2025

The purpose of OPTIMA is to find out if using a test called ‘Prosigna’ can help make safe and accurate decisions about whether or not chemotherapy treatment is needed.

People with ER-positive, HER2-negative breast cancer are usually offered both chemotherapy and hormone (endocrine) treatment to reduce the risk of the cancer coming back in the breast or elsewhere. Currently we don’t have a single test that can tell us whether or not someone might benefit from chemotherapy, so some people may receive chemotherapy who don’t need it. Chemotherapy can have unpleasant short- and long-term side-effects.

The study is looking at whether the Prosigna test can predict if patients with breast cancer which has spread to lymph nodes or with larger cancers are likely to benefit from chemotherapy. 

Who is it for?

OPTIMA may be right for you if you are a man or a woman, aged 40 years and over, and you have breast cancer that is hormone sensitive (oestrogen (ER) positive) and HER2 negative, and:

  • Has spread to the lymph nodes, OR
  • Is a larger size cancer without spread to the lymph nodes within or surrounding the breast.

Study details

Following consent, all participants will provide a tumour sample from their surgery and will be randomised. The sample will be sent to Sydney, Australia for Prosigna testing. 

If you join this clinical trial, you will be entered into one of two groups:

Group 1: usual treatment group; you will receive chemotherapy and hormone treatment. 

Group 2 your treatment will depend on the result of the Prosigna test. 

  • You could receive chemotherapy and hormone treatment, if the Prosigna test predicted a benefit from chemotherapy. 

Or

  • You could receive only hormone treatment if the Prosigna test did not predict a benefit from chemotherapy.

The study aims to recruit 4500 participants from UK, Sweden, Norway, Australia and New Zealand. Waikato, Tauranga, Wellington and Palmerston North.

More information can be found here and here

New Zealand

Palmerston North
Tauranga
Waikato
Wellington

Australia

NSW
QLD
SA
TAS
VIC
WA

If you think you might be a candidate for this trial, use the contact details supplied, or talk to your doctor.

Want to access a trial that's not in your area? It's not always possible, but if you're interested, email us at intouch@bcf.org.nz

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