PROTECTING FERTILITY T
Many breast cancer clinical trials do not take
fertility into account, but with clinical trials skewing towards younger age groups, it is necessary to consider it as a trial endpoint, says Dr Bora Lim, oncology associate professor at Baylor College of Medicine, Texas. Having any measure that indicates fertility protection and the ability to get pregnant after the trial will not only benefit the participants but can also be used for marketing of the drug if approved, Lim says. Such measures can be as straightforward as
follow-up questions, but in-depth patient assessments on fertility would improve the clinical trial design, says Dr Ann Partridge, breast cancer medical oncologist at Dana-Farber Cancer Institute in Massachusetts. An intervention’s side-effect profile is not complete if there is limited information on ovarian function, she adds. 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 for trial patients who are interested in seeking in vitro fertilisation, she adds.
harm in a clinical trial. Pharma companies should consider
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In a global analysis, the number of women under 60 years old with breast cancer, increased from 30% before
Growing numbers 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, increased noticeably from 30% before 2001 to 90% after 2014, according to clinical data company Phesi. Clinical trial sponsors should analyse the data of breast cancer populations to optimise the trial design to better serve targeted cohorts, says Phesi president 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. 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 for the 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 considerations need to be addressed when designing a clinical trial as the study needs to be convenient for every patient, she points out. 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 who are keen to participate in clinical trials, Li says. Breast cancer patients, especially the younger ones, tend to have higher education and seek out more information about their disease on the internet or through patient network groups rather than simply relying on paternalistic treatments, Lim adds.
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