Elacestrant and exemestane for patients with pretreated HR+/HER2- metastatic breast cancer and [18F]-FES-avid lesions (COMBINE): a proof-of-concept phase 2 clinical trial

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-519792-25-00

Acronym

UID 4270

Enrollment

Registered

2025-10-10

Start date

Unknown

Completion date

Unknown

Last updated

2025-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic hormone receptor-positive/HER2-negative breast cancer

Brief summary

6-month PFS rate per RECIST v 1.1

Detailed description

Adverse Events per CTCAE 5.0, Median Overall Survival, Overall Response Rate per RECIST 1.1, Median QoL change from baseline to week 8 of treatment measured by EORTC QLQ-C30 and FACT-ES v.4 questionaries, 6-months Progression-free survival (PFS) rate per RECIST 1.1 according to baseline FES-SUV and SUV variation of FES

Interventions

DRUGEstroTep 500 MBq/mL

DRUGsolution injectable

DRUGELACESTRANT

DRUGEXEMESTANE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
6-month PFS rate per RECIST v 1.1	—

Secondary

Measure	Time frame
Adverse Events per CTCAE 5.0, Median Overall Survival, Overall Response Rate per RECIST 1.1, Median QoL change from baseline to week 8 of treatment measured by EORTC QLQ-C30 and FACT-ES v.4 questionaries, 6-months Progression-free survival (PFS) rate per RECIST 1.1 according to baseline FES-SUV and SUV variation of FES	—

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026