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Perioperative anti-inflammatory to reduce breast cancer recurrence

Perioperative ketorolac in high risk breast cancer patients with and without inflammation – a prospective randomised placebo-controlled trial.

Status
Completed
Cancer types
Breast cancer
Trial phase
3

Funding

€251,595
ACF donation
€251,595
Total trial cost

Why this trial

Surgery is an important step in the treatment of many cancers, and leads to the best outcomes in breast cancer. Several observations suggest that physiological changes induced by surgery and anaesthesia may have an impact on the growth of tumour cells in breast cancer.

Anaesthesia and surgery induce major physiological changes in patients. Immune changes, inflammation, and angiogenesis necessary for wound healing may also promote the growth of cancer cells, possibly making the surgery less effective.

To counter these effects, it has been hypothesised that the use of nonsteroidal anti-inflammatory drugs (NSAIDs) at the time of surgery may improve cancer patient outcomes. However, only clinical trials will be able to confirm these findings.

Why this intervention

The researchers involved in this trial have previously shown that intra-operative ketorolac, an NSAID routinely used after surgery but rarely during, is associated with a lower risk of breast cancer recurrence.

The link between injection of ketorolac during surgery and lower risk of breast cancer was found by other researchers as well. In order to assess whether an injection of ketorolac is responsible of the risk reduction of breast cancer recurrence, the hypothesis is tested in a randomised clinical trial.

Trial design

This was a prospective, randomised, placebo-controlled, double-blind study with an inclusion period of 2 years and a 5-year follow-up period. 203 patients were recruited and treated in 4 Belgian centres.

Breast cancer patients with a moderate to high risk of cancer recurrence were randomly placed into 2 arms, ketorolac or placebo, to find out if perioperative administration of ketorolac during breast cancer surgery has an effect on survival rates.

 

Results

Administering a single dose of 30 mg of ketorolac tromethamine before surgery doesn't improve disease-free survival in high-risk breast cancer patients. There was no statistically significant difference in overall survival between the group receiving ketorolac tromethamine and the group receiving a placebo. However, the study lacked sufficient power due to lower-than-expected recurrence rates. No safety issues were observed.

These results were presented at the San Antonio Breast Cancer Symposium (SABCS), held December 4-8, 2018.

The poster can be found here. Full results are available here.

Partners

Principal Investigator:

  • Dr Patrice Forget, previously at Cliniques Universitaires Saint-Luc

Sponsor:

  • Cliniques Universitaires Saint-Luc, Brussels, Belgium

Our role

Financial support

Why we support this trial

Intervention has little or no commercial value

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Expected survival benefit

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No major hurdle for clinical implementation

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Funding

€251,595
ACF donation
€251,595
Total trial cost

Questions about participation?

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Questions about this trial?

The Anticancer Fund
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References

More info on clinicaltrials.gov: NCT01806259

Forget, P., et al (2019). Intraoperative ketorolac in high-risk breast cancer patients. A prospective, randomized, placebo-controlled clinical trial. PLoS ONE ,14(12): e0225748. https://doi.org/10.1371/journal.pone.0225748

Last updated: March 2024.