Elacestrant Monotherapy vs. Standard of Care for the Treatment of Patients With ER+/HER2- Advanced Breast Cancer Following CDK4/6 Inhibitor Therapy: A Phase 3 Randomized, Open-label, Active-controlled, Multicenter Trial
Elacestrant Monotherapy vs. Standard of Care for the Treatment of Patients With ER+/HER2- Advanced Breast Cancer Following CDK4/6 Inhibitor Therapy: A Phase 3 Randomized, Open-label, Active-controlled, Multicenter Trial
This Phase 3 clinical study compares the efficacy and safety of elacestrant to the standard of care (SoC) options of fulvestrant or an aromatase inhibitor (AI) in women and men with breast cancer whose disease has advanced on at least one endocrine therapy including a CDK4/6 inhibitor in combination with fulvestrant or an aromatase inhibitor (AI).
This is an international, multicenter, randomized, open-label, active-controlled, event-driven, Phase 3 clinical study comparing the efficacy and safety of elacestrant to the SoC options of fulvestrant or an aromatase inhibitor (AI) in postmenopausal women and in men with advanced or metastatic ER+/HER2- breast cancer, either in participants with tumors that harbor mutations in the ligand binding domain (LBD) of the estrogen receptor 1 (ESR1) gene (ESR1-mut participants) or in all participants regardless of ESR1 status (ESR1-mut and ESR1 wild type [ESR1-wt]) and whose disease has relapsed or progressed on at least one and no more than two prior lines of endocrine therapy (with documented progression), which must have included prior CDK4/6 inhibitor therapy in combination with fulvestrant or an aromatase inhibitor (AI) and for whom hormonal monotherapy with one of the SoC drugs (fulvestrant, anastrozole, letrozole, exemestane) is an appropriate treatment option.
Critical Inclusion Criteria:
Critical Exclusion Criteria:
Prior treatment with elacestrant or other investigational selective estrogen receptor degrader (SERD) or ER antagonist (D-0502, GDC-0810, GDC-0927, GDC-9545, G1T-48, LSZ102, AZD9496, SAR439859, ZN-c5, H3B-6545, bazedoxifene, lasofoxifene).
Prior anticancer or investigational drug treatment within the following windows:
Presence of symptomatic visceral disease as defined in protocol.
Los Angeles, California 90033, United States
Fort Collins, Colorado 80528, United States
Buenos Aires, Buenos Aires F.D. C1025ABI, Argentina
Montpellier, 34298, France
Paris, 75005, France
Saint-Priest-en-Jarez, 42270, France
Pátrai, Achaïa 26504, Greece
Szolnok, Jász-Nagykun-Szolnok 5004, Hungary
Nyíregyháza, Szabolcs-Szatmár-Bereg 4400, Hungary
Jerusalem, Central District 9103102, Israel
Tel-Hashomer, Central District 5265601, Israel
Roma, 00128, Italy
Palma de Mallorca, Balearic Islands 07010, Spain