Neo-N Clinical Trials Results

50% of Patients Involved in Immunotherapy Clinical Trial Are Breast Cancer Free at Surgery

Results from the Neo-N clinical trial have shown that over half of early-stage triple negative breast cancer patients involved in the immunotherapy study, had no evidence of cancer in the breast and lymph nodes at surgery following treatment.

The primary results of the Neo-N trial were announced as a late breaking abstract at the San Antonio Breast Cancer Symposium in the United States today. The trial was developed by Australian researchers and conducted by the largest independent oncology clinical trials research group in Australia and New Zealand – Breast Cancer Trials.

Neo-N investigated whether using an immunotherapy drug together with chemotherapy, is safe and effective in treating breast cancer before surgery in women and men with early triple negative breast cancer. Researchers examined if adding in immunotherapy could compensate for giving less chemotherapy. Patients received treatment before their operation, with the goal that this treatment combination could give the same outcomes but with less short and long-term side effects. 108 women participated in the study at 14 institutions in Australia, New Zealand and Italy.

Triple negative breast cancer accounts for 15% of all breast cancers. It’s a more aggressive tumour, that has a faster growth rate, a higher risk of spreading to other parts of the body and has a greater risk of recurrence.

Professor Sherene Loi is the Study Chair of the Neo-N clinical trial and says the results are a significant step forward in providing more treatment options for patients.

“Triple negative breast cancer doesn’t have any of the more common receptors that can be targeted by medications, such as hormone and HER2-blocking drugs, so it has fewer treatment options available,” Professor Loi said. “However, being able to augment the immune system against it seems to work well, which is the basis of this new treatment combination”.

“This 12-week chemo-immunotherapy treatment combination is a promising new treatment option, that has been very effective at eradicating the cancer in those patients. Those patients in whom we see eradication of the cancer have a good prognosis.”

The study found that patients with ‘immunotherapy sensitive’ cancer, as indicated by either tumour infiltrating lymphocytes, or PD-L1 positivity, had particularly high pathological complete responses (67% and 71% respectively).

“This was a very promising phase II clinical trial and we now need to prove this concept in a bigger phase III study, to confirm the efficacy of this type of treatment,” Professor Loi said.

Patients involved in the Neo-N trial are in follow-up for long term recurrence outcomes and this will be reported at a later date.

Founded in 1978, Breast Cancer Trials conducts a multicentre national and international clinical trials research program, into the treatment and prevention of breast cancer. This involves over 900 researchers in 114 institutions across Australia and New Zealand. The Neo-N clinical trial was made possible thanks to the generosity of our supporters and we are deeply grateful for their support. We also acknowledge the grant received from Tour de Cure.

For more information about Breast Cancer Trials, visit www.breastcancertrials.org.au.

Contact: BCT Communications Manager, Anna Fitzgerald – 0400 304 224 or anna.fitzgerald@bctrials.org.au

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