"ECLECTIC": EstroTEP and circulating biomarkers to determine the optimal second line therapy for ER-positive HER2-negative metastatic breast cancer patients

Conditions

Women with ER+ HER2- metastatic breast cancer who progressed on first line therapy with CDK4/6 inhibitor and aromatase inhibitor

Brief summary

Progression-free survival (PFS), defined as the time from randomization to progression or death, among randomized patients

Detailed description

Other efficacy endpoints among randomized patients: Progression-free survival (PFS) with available PERCIST tumor evaluation; Overall survival (OS) among randomized patients (arms B and C), Objective response rate (ORR), Clinical benefit rate (CBR) at 24 weeks., Above-mentioned efficacy criteria (PFS, OS, ORR and CBR at 24 weeks) will be evaluated in patients allocated to arm A., Grade 3 or 4 AEs (adverse events) according to NCI CTCAE v5.0, and their relationship to study treatment (chemotherapy or endocrine therapy) will be recorded. For 18F-FES PET/CT, serious adverse events (SAE) and any grade AEs will be collected., QLQ-C30 questionnaire measured at baseline and after 2 months of treatment.

Related papers

No related papers found yet.

Interventions

DRUGEstroTep 500 MBq/mL

DRUGsolution injectable

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression-free survival (PFS), defined as the time from randomization to progression or death, among randomized patients	—

Secondary

Measure	Time frame
Other efficacy endpoints among randomized patients: Progression-free survival (PFS) with available PERCIST tumor evaluation; Overall survival (OS) among randomized patients (arms B and C), Objective response rate (ORR), Clinical benefit rate (CBR) at 24 weeks., Above-mentioned efficacy criteria (PFS, OS, ORR and CBR at 24 weeks) will be evaluated in patients allocated to arm A., Grade 3 or 4 AEs (adverse events) according to NCI CTCAE v5.0, and their relationship to study treatment (chemotherapy or endocrine therapy) will be recorded. For 18F-FES PET/CT, serious adverse events (SAE) and any grade AEs will be collected., QLQ-C30 questionnaire measured at baseline and after 2 months of treatment.	—

Measure

Time frame

Other efficacy endpoints among randomized patients: Progression-free survival (PFS) with available PERCIST tumor evaluation; Overall survival (OS) among randomized patients (arms B and C), Objective response rate (ORR), Clinical benefit rate (CBR) at 24 weeks., Above-mentioned efficacy criteria (PFS, OS, ORR and CBR at 24 weeks) will be evaluated in patients allocated to arm A., Grade 3 or 4 AEs (adverse events) according to NCI CTCAE v5.0, and their relationship to study treatment (chemotherapy or endocrine therapy) will be recorded. For 18F-FES PET/CT, serious adverse events (SAE) and any grade AEs will be collected., QLQ-C30 questionnaire measured at baseline and after 2 months of treatment.

—

Countries

France

Outcome results

None listed