Table 1.
Trial-related factors associated with inclusion of pre-menopausal breast cancer patients in phase III clinical trials. Abbreviations: pre-menopausal breast cancer (PMBC), hormone-receptor-positive (HR+), triple-negative breast cancer (TNBC), adjusted odds ratio (aOR), confidence interval (CI), endocrine therapy (ET).
| Premenopausal Inclusion N/Ntotal (%) |
Univariate Analysisa | Multiple Binary Logistic Regression |
||
|---|---|---|---|---|
| aOR (95% CI) | P-Value | |||
| Cancer Stage | ||||
| Stages 0 – lll | 52/65 (80%) | 0.42 | ||
| Stage IV | 64/105 (60.9%) | |||
| Receptor Status | <0.001 | |||
| HER2+, TNBC, or any | 99/105 (94.3%) | – | – | |
| HR + HER2- | 31/65 (47.7%) | 0.07 (0.02–0.19) | <0.001 | |
| Endocrine Therapy | <0.001 | |||
| No ET | 119/143 (83.2%) | – | – | |
| Randomized or mandated ET | 12/27 (44.4%) | 0.21 (0.10–0.83) | 0.02 | |
| Cytotoxic Chemotherapy | <0.001 | |||
| No chemotherapy | 93/132 (70.5%) | – | – | |
| Randomized or mandated chemotherapy | 38/38 (100%) | 15.13 (1.78–128.42) | 0.01 | |
| Targeted Therapy | ||||
| No targeted therapy | 110/132 (83.3%) | 0.27 | ||
| Randomized or mandated targeted therapy | 21/31 (67.7%) | |||
| Immunotherapy | ||||
| No immunotherapy | 88/122 (72.1%) | 0.04 | – | – |
| Randomized or mandated immunotherapy | 43/48 (89.6%) | 2.19 (0.68–7.12) | 0.19 | |
| Industry Sponsorship | ||||
| No | 90/115 (78.3%) | 0.69 | ||
| Yes | 41/55 (75.5%) | |||
| Cooperative Group Sponsorship | ||||
| No | 39/47 (83%) | 0.41 | ||
| Yes | 92/123 (74.8%) | |||
| Trials that met their primary endpoint (PEP) | ||||
| No | 23/36 (63.9%) | 0.37 | ||
| Yes | 99/121 (81.8%) | |||
a Pearson's Chi-squared testing for univariate analyses was used in univariate analyses to assess the association between trial-related factors and PMBC inclusion. Trial-related factors that had p < 0.05 were included in multiple binary logistic regression analysis.