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. Author manuscript; available in PMC: 2022 Mar 1.
Published in final edited form as: Cancer Lett. 2020 Dec 9;500:64–74. doi: 10.1016/j.canlet.2020.12.014

Table 2.

Clinical Trials Aimed at Treating Patients Who Have Progressed on Endocrine Therapy or Evaluating Clinical Outcomes in luminal breast cancer patients

Trial Name Study Type Phase Treatment Study Description Trial Identifier
TREnd Interventional II palbociclib/palbociclib + ET* Asses the monotherapy and combination therapy activity of palbociclib with endocrine therapy in patients who have progressed on first- or second-line ET agents NCT02549430
MIRACLE Interventional II everolimus Evaluation of everolimus in first-line endocrine treatment of premenopausal MBC patients after progression on tamoxifen NCT02313051
BOLERO-2 Interventional III everolimus + exemestane To compare the efficacy and safety exemestane + everolimus to exemestane + placebo in postmenopausal MBC patients refractory to previous letrozole or anastrozole NCT00863655
BELLE-3 Interventional III buparlisib + fulvestrant To determine the efficacy and safety of buparlisib + fulvestrant in postmenopausal HR-positive, HER2-negative women who progressed on or after mTOR inhibitor-based treatment NCT01633060
OVER Interventional III fulvestrant ± lapatinib ± AI Comparing the efficacy of fulvestrant in combination with lapatinib or AIs in MBC patients progressing on AIs NCT02394496
ALTERNATE Interventional III fulvestrant To determine whether neoadjuvant endocrine therapy with fulvestrant or fulvestrant + anastrozole is more efficacious than anastrozole when given before surgery to reduce tumor size and inhibit growth NCT01953588
PALOMA-3 Interventional III palbociclib + fulvestrant To demonstrate the superiority of palbociclib with fulvestrant over fulvestrant alone in prolonging PFS in MBC patients that progressed after ET
TAILORx Interventional III ET +/− chemotherapy To evaluate clinical outcomes in patients with HR+, Her2-breast cancer following ET with or without chemotherapy. NCT00310180

Abbreviations: endocrine therapy (ET), human epidermal growth factor receptor 2 (Her2), mammalian target of rapamycin (mTOR), metastatic breast cancer (MBC), progression free survival (PFS), aromatase inhibitors (AIs). *ET includes anastrozole, letrozole, exemestane, fulvestrant and in the case of the TAILORx trial, tamoxifen.