In this BCT Discretionary Funding Project, researchers explored the benefits of collecting data on ovarian toxicity during clinical trials research.

New clinical trials of breast cancer treatments may be more likely to assess those treatment’s impact on ovarian function, as a result of recent research looking at why such information isn’t commonly collected in clinical trials.

Even though it is well known that chemotherapy used for the treatment of breast cancer can reduce the function and lifespan of the ovaries, the recent research surprisingly showed the main reason data on ovarian toxicity wasn’t collected in breast cancer trials was simply that “it wasn’t considered” during trial design.

“That’s quite a disconnect with what we do in clinical practice,” says lead author of the study Dr Wanda Cui, who is a medical oncologist at the Peter MacCallum Cancer Centre in Melbourne. “Young women who are premenopausal have stated that fertility issues and early menopause are critical factors in their decision making about treatment options. Studies have shown women would change their treatment decisions if one regimen was more likely to lead to impaired fertility compared to another with similar efficacy [against the cancer].”

In the study, 25 people across 14 countries were interviewed. They included clinicians, consumers, members of regulatory agencies and pharmaceutical company representatives. This study received discretionary funding support from Breast Cancer Trials, thanks to the generosity of our supporters.

One of the clinicians who participated in this research said the lack of ovarian toxicity assessment in clinical trials was “a failure of the entire research world”. As well as fertility issues, ovarian toxicity can have profound impacts on long-term bone density, cardiovascular health and cognitive function.

Dr Cui says other reasons the participants listed for not assessing treatment-related ovarian toxicity in clinical trials was the pressure on trial resources in such studies, and also that information on ovarian toxicity wasn’t currently required for regulatory drug approval. In addition, some mentioned they weren’t sure how to collect or interpret such data.

But many participants acknowledged preservation of ovarian function was fundamental to a woman’s quality of life.

“Decades ago, often the only aim of breast cancer treatment was to keep people alive,” Dr Cui says. “Now there’s been a shift. Although keeping them alive is still fundamental, there’s much more emphasis on survivorship – what’s life like after cancer?”

She says that as a result of the research, there is now more interest from international oncology groups as to how to collect data on ovarian toxicity during treatment trials. “We’ve already started to see more of a conversation and a bit more interest in looking at these data in clinical trials.”


Wanyuan Cui, Kelly-Anne Phillips, Prudence A. Francis, Richard A. Anderson, Ann H. Partridge, Sherene Loi, Sibylle Loibl, Louise Keogh. Understanding the barriers to, and facilitators of, ovarian toxicity assessment in breast cancer clinical trials. The Breast. 2022; 64: 56–62. https://doi.org/10.1016/j.breast.2022.05.002

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Dr Wanda Cui

Dr Wanda Cui received Discretionary Funding thanks to the generosity of our supporters to conduct this research.

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