Elacestrant versus Standard Endocrine Therapy in Women and Men with Node positive, Estrogen Receptor-positive, HER2-negative, Early Breast Cancer with High Risk of Recurrence - A Global, Multicenter, Randomized, Open-label Phase 3 Study (ELEGANT)

Conditions

Early Breast Cancer with High Risk of Recurrence, Estrogen Receptor-positive, HER2-negative, Node-positive

Brief summary

IBCFS: the time from date of randomization to the date of first occurrence of: • ipsilateral invasive breast tumor recurrence, • local/regional invasive breast cancer recurrence, • distant recurrence, • contralateral invasive breast cancer, or • death attributable to any cause.

Detailed description

DRFS: the time from randomization to distant recurrence or death from any cause, whichever occurred first., OS: the time from randomization to death from any cause., IDFS: the time from randomization to the first occurrence of local or regional recurrence, contralateral recurrence, second primary non-breast invasive cancer, distant recurrence, or death attributable to any cause., Adverse events (AEs), treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) as well as changes in clinical laboratory values and vital sign measurements., Change from baseline in the global health status quality of life scale score at 6 and 12 months and annually thereafter, as assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)., Change from baseline in the physical functioning sub-scale score at 6 and 12 months and annually thereafter, as assessed by EORTC QLQ-C30., Change from baseline in the breast cancer Endocrine Therapy Symptoms sub-scale score at 6 and 12 months and annually thereafter, as assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Breast Cancer module (EORTC QLQ-BR42)., Change from baseline in side effects/tolerability at 6 and 12 months and annually thereafter, as assessed by the Question 168 of the European Organization for the Research and Treatment of Cancer Question Library (EORTC Q168)., Elacestrant PK parameters, exposure-response analyses between elacestrant PK and efficacy/safety endpoints.

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Interventions

DRUGLETROZOLE

DRUGELACESTRANT

DRUGANASTROZOLE

DRUGEXEMESTANE

DRUGTAMOXIFEN

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
IBCFS: the time from date of randomization to the date of first occurrence of: • ipsilateral invasive breast tumor recurrence, • local/regional invasive breast cancer recurrence, • distant recurrence, • contralateral invasive breast cancer, or • death attributable to any cause.	—

Secondary

Measure	Time frame
DRFS: the time from randomization to distant recurrence or death from any cause, whichever occurred first., OS: the time from randomization to death from any cause., IDFS: the time from randomization to the first occurrence of local or regional recurrence, contralateral recurrence, second primary non-breast invasive cancer, distant recurrence, or death attributable to any cause., Adverse events (AEs), treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) as well as changes in clinical laboratory values and vital sign measurements., Change from baseline in the global health status quality of life scale score at 6 and 12 months and annually thereafter, as assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)., Change from baseline in the physical functioning sub-scale score at 6 and 12 months and annually thereafter, as assessed by EORTC QLQ-C30., Change from baseline in the breast cancer	—

Measure

Time frame

DRFS: the time from randomization to distant recurrence or death from any cause, whichever occurred first., OS: the time from randomization to death from any cause., IDFS: the time from randomization to the first occurrence of local or regional recurrence, contralateral recurrence, second primary non-breast invasive cancer, distant recurrence, or death attributable to any cause., Adverse events (AEs), treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) as well as changes in clinical laboratory values and vital sign measurements., Change from baseline in the global health status quality of life scale score at 6 and 12 months and annually thereafter, as assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)., Change from baseline in the physical functioning sub-scale score at 6 and 12 months and annually thereafter, as assessed by EORTC QLQ-C30., Change from baseline in the breast cancer

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Countries

Austria, Belgium, Czechia, Denmark, Finland, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Romania, Spain, Sweden

Outcome results

None listed