Table 1.
Ongoing clinical studies applying gene expression profiling in early breast cancer.
| Clinical Trials (NCT#) and Study Phase | GEP Assay | Breast Cancer Population | Clinical Endpoints | Study Description |
|---|---|---|---|---|
| OPTIMA (ISRCTN 42400492) Phase III |
Prosigna/PAM50 | HR+/HER2−, pN1–2 or pN1mi with pT ≥ 20 mm or pN0 with pT ≥ 30 mm | iDFS | A de-escalation clinical trial to tailor adjuvant therapy for HR+/HER2− high clinical risk breast cancer |
| RxPONDER (NCT01272037) Phase III |
Oncotype DX | HR+/HER2−, 1–3 N+, recurrence score ≤ 25 | iDFS | Role of recurrent score in predicting benefit of adjuvant chemotherapy in women with LN+ disease |
| GERICO 11/ASTER 70s (NCT01564056) Phase III |
Genomic Grade test | HR+/HER2−, N0 or N+, age ≥ 70 years, PS ≤ 2 | OS | Adjuvant systemic treatment for ER+/HER2− breast cancers in patients over 70 years of age according to genomic grade index: chemotherapy + endocrine therapy vs. endocrine therapy |
| EXET (NCT04016935) Observational |
EndoPredict | HR+/HER2−, stage I–III, 0–3 N+, potential adjuvant chemotherapy, no neoadjuvant chemotherapy | DRFS | Extended Endocrine Trial: A prospective registry study testing the impact of EndoPredict on extended endocrine therapy decisions and patients’ outcomes |
| RESCUE (NCT03503799) Observational |
EndoPredict | HR+/HER2−, stage I–III, 0–3 N+ | DRFS | Prospective assessment of disease progression in breast cancer patients undergoing EndoPredict test—a care research study |
| DxCARTES (NCT03819010) Phase II |
Oncotype DX | HR+/HER2−, Ki67 ≥ 20, stage II-IIIb T2–T4, N0–N2, age ≥ 18, PS ≤ 1 | Molecular differences on recurrence score between pre- and post-treatment | Neoadjuvant letrozole + palbociclib in HR+/HER2− patients with stage II–IIIb breast cancer, and pretreatment recurrence scores: 18–25 or 26–100 by Oncotype DX testing. Analysis of recurrent score and pathological feature changes at time of surgery |
| PLATO (NCT03900637) Phase II |
MammaPrint | HR+/HER2−, stage I–IIIA, ineligible for BCS, age ≥ 19, PS ≤ 2 | Conversion rate | Multicenter study to increase BCS rate with personalized neoadjuvant strategy in HR+/HER2− breast cancer for whom BCS is not feasible. Neoadjuvant chemotherapy and endocrine therapy are conducted on genomic high and low risk patients, respectively |
| NSABP FB-13 (NCT03628066) Phase II |
Oncotype DX | HR+/HER2−, T2–T4, candidate for neoadjuvant HT, premenopausal status, PS ≤ 1, recurrence score < 26 | Complete cell cycle arrest (percentage of patients with a Ki67 < 2.7%) | Neoadjuvant treatment for premenopausal HR+/HER2− breast cancer patients and evaluation of the clinical and biological effects of palbociclib with ovarian suppression and letrozole |
| POETIC-A (NCT04584853) Phase III |
AIR-CIS | HR+/HER2−, postmenopausal status, ≥1.5 cm, grade 3 and/or Ki67 level ≥ 20% | Time to tumor recurrence (local or distant disease) | Preoperative endocrine therapy for individualized therapy with abemaciclib |
Aromatase Inhibitor Resistant-CDK4/6 Inhibitor Sensitive (AIR-CIS) test; Breast Conservative Surgery (BCS; DRFS, Distant Recurrence-free Survival; GEP, Gene Expression Profiling; Hormonal Therapy (HT); iDFS, invasive Disease-Free Survival; OS, Overall Survival.