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Clinical Trials in Germany / NCT07563595
Recruiting Observational

Elacestrant in Patients With ER+ HER2- ESR1-mutated Locally Advanced or Metastatic Breast Cancer

NCT07563595 · tracked via the Priya Life Science Germany tracker
Sponsor
iOMEDICO AG
Phase
Observational
Started
2026-06-19
Last updated
2026-06-25

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

Elacestrant →Standard of care (Investigator Choice)

Elacestrant: According to the Summary of Product Characteristics (SmPC)

Standard of care (Investigator Choice): Treatment decision of investigator

Study summary

The objective of this non-interventional study (NIS) is to evaluate prevalence of ESR1 mutation after endocrine therapy in the palliative setting, quality of life, tolerability, and safety and to describe treatment detail and adverse event (AE) management in postmenopausal women with locally advanced and/or metastatic ER+ HER2- ESR1-mutated breast cancer and second line treatment with elacestrant according to SmPC (Summary of product characteristics) in a real-world setting.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Signed and dated informed consent form * Postmenopausal women * Age ≥18 years * Eastern Cooperative Oncology Group Performance Status (ECOG) \< 2 * Locally advanced and/or metastatic ER+ HER2- breast cancer * Histologically proven ER positivity (defined as ≥1% staining by immunohistochemistry (IHC)) * Histologically proven HER2 negativity (defined as a IHC0 or IHC1+ score by IHC or a negative result by in situ hybridization (ISH), optionally combined with a IHC2+ score) * Disease progression following first line ET + CDKi * No more than one prior ET line in the advanced/metastatic setting and intention for 2nd-line treatment with elacestrant according to current elacestrant SmPC as assessed by the treating physician (ESR1 testing can be done after inclusion) * For patients with proven ESR1mut: Study inclusion the latest 2 weeks after start of elacestrant treatment Exclusion Criteria * Prior chemotherapy in the advanced/metastatic setting * Contraindications according to elacestrant SmPC, except for ESR1 test result for patients included prior to ESR1 testing. * Participation in an interventional clinical trial within 30 days prior to enrolment or simultaneous participation in an interventional clinical trial (except follow-up phase)

Primary outcome measure(s)

  • Change from baseline in EORTC global health scale — From Time of enrollment until month 11
    Change from baseline quality of life (QoL) over time for the global health scale of the EORTC QLQ- C30 questionnaire The EORTC QLQ- C30 global health scale ranges from 0 to 100, with higher scores indicating better quality of life.

Trial sites (3)

FacilityCityRegionStatus
Praxis für interdisziplinäre Onkologie & Hämatologie Freiburg im Breisgau Germany Recruiting
St. Louise Frauen- und Kinderklinik Paderborn Germany Recruiting
Gemeinschaftspraxis für Hämatologie und Onkologie Ravensburg Germany Recruiting

More iOMEDICO AG trials in Germany

Registry Platform Colorectal Cancer Active, not recruiting
A Non-interventional Study of Melphalan Flufenamide (Melflufen) (Pepaxti®) and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma (R/RMM) Recruiting
Registry Platform Hematologic Malignancies (RUBIN) - Extension of Tumor Registry Lymphatic Neoplasms Recruiting
Research Platform Myelofibrosis and Anemia Recruiting
Breast Cancer Registry Platform Recruiting

Other trials for the same condition

A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy Recruiting
OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer Active, not recruiting
Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects Recruiting
AXillary Surgery After NeoAdjuvant Treatment Recruiting
A Study of Tobemstomig + Nab-Paclitaxel Compared With Pembrolizumab + Nab-Paclitaxel in Participants With Previously Untreated, PD-L1-Positive, Locally-Advanced Unresectable or Metastatic Triple-Negative Breast Cancer Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07563595 on ClinicalTrials.gov ↗ ← All trials in Germany