EORTC 2129-BCG: Elacestrant for treating ER+/HER2- breast cancer patients with ctDNA relapse (TREAT ctDNA)

Conditions

Breast cancer

Brief summary

Distant metastasis free survival (DMFS) defined as the time from randomisation until first distant metastatic recurrence or death from any cause, whichever occurs first

Detailed description

Invasive disease-free survival (iDFS) rate according to the STEEP criteria including locoregional recurrence, distant metastasis, invasive contralateral breast cancer and invasive non-breast second cancers, deaths from any cause as events, Relapse-free survival (RFS) rate according to the STEEP criteria, including locoregional recurrence, distant metastasis, deaths from any cause as events, Overall survival rate, Safety including but not limited to all adverse events, serious adverse events, laboratory abnormalities graded according to CTCAE version 5.0, Patient reported outcomes: tolerability & benefit as measured by the QLQ-C30, QLQ-BR42 and EORTC IL46

Michail Ignatiadis, Emmanouil Saloustros, Ana Joaquim, Fanny Grillet, Yiola Marcou et al. (18 authors)

Journal of Clinical Oncology2025-05-281 citations

10.1200/jco.2025.43.16_suppl.tps620

Interventions

DRUGTAMOXIFEN

DRUGGOSERELIN

DRUGANASTROZOLE

DRUGELACESTRANT

DRUGTRIPTORELIN

DRUGEXEMESTANE

DRUGLETROZOLE

DRUGLEUPRORELIN

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Distant metastasis free survival (DMFS) defined as the time from randomisation until first distant metastatic recurrence or death from any cause, whichever occurs first	—

Secondary

Measure	Time frame
Invasive disease-free survival (iDFS) rate according to the STEEP criteria including locoregional recurrence, distant metastasis, invasive contralateral breast cancer and invasive non-breast second cancers, deaths from any cause as events, Relapse-free survival (RFS) rate according to the STEEP criteria, including locoregional recurrence, distant metastasis, deaths from any cause as events, Overall survival rate, Safety including but not limited to all adverse events, serious adverse events, laboratory abnormalities graded according to CTCAE version 5.0, Patient reported outcomes: tolerability & benefit as measured by the QLQ-C30, QLQ-BR42 and EORTC IL46	—

Measure

Time frame

Invasive disease-free survival (iDFS) rate according to the STEEP criteria including locoregional recurrence, distant metastasis, invasive contralateral breast cancer and invasive non-breast second cancers, deaths from any cause as events, Relapse-free survival (RFS) rate according to the STEEP criteria, including locoregional recurrence, distant metastasis, deaths from any cause as events, Overall survival rate, Safety including but not limited to all adverse events, serious adverse events, laboratory abnormalities graded according to CTCAE version 5.0, Patient reported outcomes: tolerability & benefit as measured by the QLQ-C30, QLQ-BR42 and EORTC IL46

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Countries

Belgium, Cyprus, France, Germany, Greece, Ireland, Italy, Netherlands, Portugal, Spain, Sweden

Outcome results

None listed