Trial Design Overview

What were the key features of the PALOMA-3 trial?

PALOMA-3 was a randomised, double-blind, placebo-controlled, Phase III study to assess the efficacy of PALBACE^® in combination with fulvestrant in premenopausal/perimenopausal and postmenopausal women with HR+/HER2- mBC who had progressed on or after prior ET.¹

PALOMA-3 Trial Design¹

Adapted from Cristofanilli M, et al. 2016.¹

*Defined as progression during or within 1 month after the end of prior ET in the context of metastatic disease or progression during or within 12 months after discontinuation of adjuvant ET. Overall, 21% of patients had not received prior treatment for their metastatic disease (first line). Premenopausal/Perimenopausal patients received the LHRH agonist goserelin for at least 4 weeks prior to and for the duration of the trial.¹
^†Sensitivity to prior hormonal therapy was defined as documented clinical benefit (CR, PR or SD ≥24 weeks) to ≥1 prior hormonal therapy regimen in the metastatic setting or ≥24 months of adjuvant hormonal therapy before recurrence.¹
^‡Evaluated according to RECIST version 1.1.^1
§ORR was defined as confirmed CR or PR.^1
||CBR was defined as CR or PR or SD for ≥24 weeks.^1
¶Premenopausal/Perimenopausal patients received goserelin or an alternative LHRH agonist for at least 4 weeks prior to and for the duration of the trial.^1,2

AI, aromatase inhibitor; CDK, cyclin-dependent kinase; CNS, central nervous system; CR, complete response; CT, chemotherapy; ECOG, Eastern Cooperative Oncology Group; ET, endocrine therapy; HR+/HER2-, hormone receptor-positive/ human epidermal growth factor receptor 2-negative; IM, intramuscularly; LHRH, luteinising hormone-releasing hormone; mBC, metastatic breast cancer; mTOR, mechanistic target of rapamycin; N, total number of patients; n, number of patients; PFS, progression-free survival; PI3K, phosphoinositide 3-kinase; PR, partial response; RECIST, Response Evaluation Criteria In Solid Tumours; SD, stable disease.

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