Women participate in a run to support breast cancer research.

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, Clinical Trials Arena

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. Read more …