Inclusion of premenopausal women in breast cancer clinical
trials
by Kelsey L.
Corrigan, Ramez Kouzy, Joseph Abi Jaoude, Roshal R. Patel, Rachel M. Layman,
Sharon H. Giordano, Wendy A. Woodward, Benjamin D. Smith, Simona F. Shaitelman,
Ethan B. Ludmir
The Breast: VOLUME
66, P204-207, DECEMBER 01, 2022
Background
Patients with
premenopausal breast cancer (PMBC) have been historically excluded from some
clinical trials because of the limitations of using endocrine therapy (ET) in
this population. We analyzed breast cancer randomized clinical trials (RCTs) to
determine the rates of and factors associated with inclusion of PMBC patients
to provide a benchmark for PMBC inclusion in RCTs moving forward.
Methods
Using ClinicalTrials.Gov, we
identified breast cancer phase III RCTs and extracted inclusion criteria and
patient enrollment information. Multiple binary logistic regression modeling
was used to assess trial-related factors that were associated with PMBC patient
inclusion.
Results
Of 170 breast
cancer RCTs identified, 131 (77.1%) included PMBC patients. Sixty-five (38.2%)
trials analyzed patients with hormone-receptor-positive (HR+) and HER2-negative
(HER2-) breast cancer, of which 31 (47.7%) allowed for enrollment of PMBC
patients. Lower rates of PMBC inclusion were seen in trials that studied
HR+/HER2-patients (47.7% PMBC inclusion in HR+/HER2-trials vs. 94.3% in
non-HR+/HER2-trials, aOR 0.07 [95% CI: 0.02–0.19], p < 0.001) and
in trials that randomized or mandated ET (44.4% in ET trials vs. 83.2% in
non-ET trials, aOR 0.21 [95% CI: 0.10–0.83], p = 0.02). Trials
studying chemotherapy (CT) were associated with inclusion of PMBC patients
(100% in CT trials vs. 70.5% in non-CT trials, a OR 14.02 [95% CI:
1.54–127.91], p = 0.01). All surgical and radiation therapy clinical
trials allowed for the inclusion of PMBC patients in their eligibility
criteria.
Conclusions
Breast cancer
clinical trials should carefully select their enrollment criteria and consider
inclusion of premenopausal patients when appropriate.
