PROSPECTIVE

PROSPECTIVE is based on a previous project called PROSPECT where people who apparently had a single low risk cancer had an MRI scan before surgery. When they looked at the first results, they found that only 1 of 101 patients had the cancer come back in the first 5 years despite not having had radiotherapy.  This is much lower than expected.

PROSPECTIVE is designed to address the question of whether PROSPECT findings can be repeated at a larger number of hospitals.

PROSPECTIVE is open to people who:

• Are 50 years of age or older
• Have early breast cancer (breast cancer that is only in the breast and may or may not have spread to lymph nodes in the breast or armpit)
• The breast cancer has been found by standard imaging using a mammogram with or without an ultrasound.

People taking part in PROSPECTIVE will have an MRI, followed by surgery. The results of the MRI and looking at a sample of the cancer removed at surgery will be used to work out if the cancer has a low or high risk of coming back. These two factors will be used to select people who will not have radiotherapy after breast surgery. That is, they will receive less treatment than usual. This is known as “treatment optimisation” or “de-escalation”.

Those whose MRI is not clear or shows extra cancer, and/or has higher risk features, will be recommended to have standard treatment that may also include radiotherapy and other treatments. They will discuss their treatment options with the study team.

There will be two study groups:

• Arm A: No radiotherapy (will have other standard treatments for this type of breast cancer)

OR

• Arm B: Standard treatment (can include radiotherapy, as well as hormone treatment, chemotherapy)

Participants will be followed up 11 times after their surgery in the clinic or by phone:

• At 6 months
• Every 12 months for 5 years (5 times)
• Every 12 months for years 6-9 (4 times by phone)
• At 10 years.

People taking part can choose to provide blood samples for research, and complete questionnaires about how they feel about the chance of cancer coming, back, the results of their surgery, and the effects of breast cancer on their physical and mental health.

PROSPECTIVE will recruit about 1400 patients over 4 years. All registered participants will be followed until the 300^th patient in Arm A1 has reached 10 years of follow up.

PROSPECTIVE will involve 7 sites in Australia and will also open internationally.

Please click here for further information about taking part in PROSPECTIVE

Prof Bruce Mann is the Study Chair of the PROSPECTIVE clinical trial.