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May 18, 2022

Fertility impact questions swirl as breast cancer clinical trials recruit younger patients

Clinical Trials Arena spoke to experts who point to how additional study design parameters can measure and alleviate fertility risk.

By Urtė Fultinavičiūtė

The effect of breast cancer therapy on fertility may have to be accommodated in future clinical trials owing to the trend of more younger patients participating in studies.

Many breast cancer clinical trials do not take fertility into account, but with clinical trials skewing younger, it is necessary to consider it as a trial endpoint, says Baylor College of Medicine oncology associate professor Dr Bora Lim. Having any measure that indicates fertility protection and ability to get pregnant after the trial will benefit not only the participants but can also be used for marketing of the drug if approved, Lim tells Clinical Trials Arena.

Such measures can be as straightforward as follow-up questions, but in-depth patient assessments on fertility would improve the clinical trial design, notes Dana-Farber Cancer Institute breast cancer medical oncologist Dr Ann Partridge. An intervention’s side effect profile is not complete if there is limited information on ovarian function, Partridge explained.

To reduce therapeutic impact on the ovaries, breast cancer clinical trials should consider the administration of LHRH antagonists, Lim adds. LHRH antagonists stop ovaries from producing oestrogen and progesterone, thus putting the eggs to sleep. The eggs are therefore protected from the cancer medication, which is designed to kill any renewing cells. “If the patient gets a chance of stopping the [cancer] treatment, this opens the door for them to get pregnant,” she explains.

Supportive measures like fertility consultations are needed if patients might be exposed to potential ovarian harm in a clinical trial, Lim notes. Pharma companies should consider financial support to trial patients who are interested in seeking in vitro fertilisation, she adds.

Increase of younger breast cancer clinical trial participants

In a global analysis of 2.5 million patient records, the number of women under 60 years old with breast cancer participating in clinical trials noticeably increased from 30% before 2001 to 90% after 2014, according to clinical data company Phesi. There are 2,921 ongoing breast cancer clinical trials and there are 522 in the planning stage, GlobalData’s Clinical Trials Database shows. Most of the studies are in Phase II with 1,226 ongoing or planned trials, with 735 in Phase I and 394 in Phase III. GlobalData is Clinical Trials Arena’s parent company.

Clinical trial sponsors should analyse the data of breast cancer populations to optimise the trial design to better serve targeted cohorts, says Phesi CEO and founder Dr Gen Li. Detailed understanding of participants will give equal opportunities to the younger populations, as well as the older ones, Li adds.

More room needed for younger study participants

Even with real-world patients getting younger, they still need higher representation in clinical trials, Partridge says. Deeper knowledge of breast cancer, leading to increased access to diagnostics, are reasons why there is an increase in diagnosis of breast cancer among younger women, Li notes.

Younger patients have more logistical concerns, such as employment and childcare, Partridge says. These concerns need to be addressed when designing a clinical trial as the study needs to be convenient for every patient, she adds. Breast cancer in younger patients also tends to be more aggressive when the same subtype is compared in older patients, which warrants more enrolment in clinical trials, Lim says.

There is value in targeting younger patients as they are motivated to participate in studies. For example, triple-negative breast cancer has gained intensity in diagnostics but has limited reliable therapies. This results in motivated patients to participate in clinical trials, Li says. Breast cancer patients, especially the younger ones, tend to have higher education who seek out for more information about their disease on the internet or patient network groups rather than simply relying on paternalistic treatments, Lim adds.

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