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

iOMEDICO AG500 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

Breast Cancer

Interventions

ElacestrantDRUG

According to the Summary of Product Characteristics (SmPC)

Standard of care (Investigator Choice)DRUG

Treatment decision of investigator

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (3)

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

Outcomes

Primary Outcomes

Change from baseline in EORTC global health scale

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.

Time frame: From Time of enrollment until month 11

Secondary Outcomes

Time to deterioration in global health scale (EORTC QLQ-C30)

Time to deterioration in global health scale of EORTC QLQ-C30 The EORTC QLQ- C30 global health scale ranges from 0 to 100, with higher scores indicating better quality of life.

Time frame: From Time of enrollment until month 11

Time to deterioration in functional scores (EORTC QLQ-C30)

Time to deterioration in functional scores of EORTC QLQ-C30. The EORTC QLQ- C30 functional score ranges from 0 to 100, with higher scores indicating better quality of life.

Time frame: From Time of enrollment until month 11

Time to deterioration in symptom scores (EORTC QLQ-C30)

Time to deterioration in symptom scores of EORTC QLQ-C30 The EORTC QLQ- C30 symptom score ranges from 0 to 100, with lower scores indicating better quality of life.

Time frame: From Time of enrollment until month 11

Change from baseline in functional and symptom scores

Change from baseline in functional and symptom scores of EORTC QLQ-C30 The EORTC QLQ- C30 functional and symptom scores ranges from 0 to 100, with higher scores indicating better quality of life (for functional scores), and lower indication better quality of life for symptom scores.

Time frame: From Time of enrolment until up to 11 months after enrolment.

Change from baseline in visual analogue scale (VAS)

Central Contacts

Laura Serrer

CONTACT

+49761152420 eleni@iomedico.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Change from baseline in EQ-5D-5L visual analogue scale (VAS); The EQ-5D-5L VAS ranges from 0 to 100, with higher scores indicating better quality of life.

Time frame: From Time of enrollment until month 11.

Change from baseline in index value

Change from baseline in EQ-5D-5L Index Value The EQ-5D-5L index value ranges from -0.661 to 1, with higher scores indicating better quality of life.

Time frame: From Time of enrollment until month 11.

Change from baseline in all scales of EQ-5D-5L

Change from baseline in all scales of EQ-5D-5L The scales of EQ-5D-5L range from 1 to 5, with lower scores indicating better quality of life.

Time frame: From Time of enrollment until month 11.

Prevalence of ESR1 mutation

Assess prevalence of ESR1mut in patients intended for elacestrant treatment as well as the testing methodology and results for ESR1 mutations.

Time frame: Baseline

Drug safety: Frequency

Frequency of specific (serious) adverse drug reactions ((S)ADRs) (nausea, vomiting, decreased appetite)

Time frame: From time of treatment start until 30 days after end of elacestrant treatment

Drug safety: Incidence of adverse events

Incidence of (serious) adverse events ((S)AEs), (serious) adverse drug reactions ((S)ADRs)

Time frame: From time of treatment start until 30 days after end of elacestrant treatment

Drug safety: Change from baseline in AST (Aspartate Aminotransferase)

Change from baseline in AST

Time frame: From time of treatment start until 30 days after end of elacestrant treatment (max. 24 months)

Drug safety: Change from baseline in ALT (Alanine Aminotransferase)

Change from baseline in ALT

Time frame: From time of treatment start until 30 days after end of elacestrant treatment (max. 24 months)

Drug safety: Change from baseline in bilirubin

Change from baseline in bilirubin

Time frame: From time of treatment start until 30 days after end of elacestrant treatment (max. 24 months)

Patients and disease characteristics: Age

Assess patients characteristics in patients with intention for treatment with elacestrant: Age (descriptive statistics, categorical (\</≥ 65))

Time frame: Baseline

Patients and disease characteristics: Body mass index (BMI)

Assess patients characteristics in patients with intention for treatment with elacestrant: BMI (descriptive statistics, categorical (underweight, normal weight, overweight, obese))

Time frame: Baseline

Patients and disease characteristics: ECOG Performance status

Assess patients characteristics in patients with intention for treatment with elacestrant: ECOG Performance status

Time frame: Baseline

Patients and disease characteristics: CCI (Charlson score and contributing diseases)

Assess patients characteristics in patients with intention for treatment with elacestrant: CCI (Charlson score and contributing diseases)

Time frame: Baseline

Patients and disease characteristics: Time since diagnosis

Assess disease characteristics in patients with intention for treatment with elacestrant: Time since diagnosis (descriptive statistics)

Time frame: Baseline

Patients and disease characteristics: TNM staging

Assess disease characteristics in patients with intention for treatment with elacestrant: TNM staging (including AJCC) at initial diagnosis

Time frame: Baseline

Patients and disease characteristics: Metastatic sites

Assess disease characteristics in patients with intention for treatment with elacestrant: • Metastatic sites at inclusion

Time frame: Baseline

Patients and disease characteristics: Tumor Grading

Assess disease characteristics in patients with intention for treatment with elacestrant: Tumor Grading at initial diagnosis and inclusion

Time frame: Baseline

Patients and disease characteristics: HR and HER2 status

Assess disease characteristics in patients with intention for treatment with elacestrant: HR status and HER2 status at initial diagnosis and at inclusion

Time frame: Baseline

Patients and disease characteristics: Prior adjuvant chemotherapy

Assess disease characteristics in patients with intention for treatment with elacestrant: Prior adjuvant chemotherapy

Time frame: Baseline

Patients and disease characteristics: Prior adjuvant endocrine therapy

Assess disease characteristics in patients with intention for treatment with elacestrant: Prior adjuvant endocrine therapy

Time frame: Baseline

Patients and disease characteristics: prior CDKi/endocrine therapy in the palliative setting

Assess disease characteristics in patients with intention for treatment with elacestrant: Type and duration of prior CDKi/endocrine therapy in the palliative setting (descriptive statistics, categorical ≤6 months / \>6 months; ≤12 months / \>12 months)

Time frame: Baseline

Patients and disease characteristics: Disease site

Assess disease characteristics in patients with intention for treatment with elacestrant: Disease site (bone-only / visceral / non-visceral (not bone-only)) at inclusion

Time frame: At time of enrollment

Patients and disease characteristics: concomitant diseases

Assess disease characteristics in patients with intention for treatment with elacestrant: concomitant diseases

Time frame: Baseline

Use of concomitant medication

Assess the use of concomitant medication during treatment with elacestrant.

Time frame: max. 24 months; from the patient-specific study start to end of study (during elacestrant treatment)

Assess parameters of physicians' treatment decision making using a questionnaire

Frequency of distinct parameters affecting therapy choice; questionnaire completed by treating physician.

Time frame: Baseline

Frequency of first subsequent systemic antineoplastic therapy for ESR1wt patients and ESR1mut patients without elacestrant treatment

Assess second-line treatments for all patients by ESR1 status (Frequency of first subsequent systemic antineoplastic therapy for ESR1wt patients and ESR1mut patients without elacestrant treatment (refers to first treatment received starting from second line)

Time frame: max. 24 months; at patient patient-specific start of treatment

Details on treatment with elacestrant: reason for end of treatment

Assess reason for end of treatment (treatment with elacestrant)

Time frame: max. 24 months; from the patient-specific study start to end of study (during elacestrant treatment)

Details on treatment with elacestrant: dose intensity

Assess dose intensity (treatment with elacestrant) as prescribed by the treating physician

Time frame: max. 24 months; from the patient-specific study start to end of study (during elacestrant treatment)

Details on treatment with elacestrant: frequency and type of dose modification

Assess Frequency and type of dose modifications (dose reductions, interruptions) compared to SmPC of elacestrant.

Time frame: max. 24 months; from the patient-specific study start to end of study (during elacestrant treatment)

Details on treatment with elacestrant: reasons for dose modifications and interruptions

Assess reasons for dose modifications and interruptions (elacestrant treatment)

Time frame: max. 24 months; from the patient-specific study start to end of study (during elacestrant treatment)

Treatments following elacestrant therapy: Type of first subsequent systemic antineoplastic therapy

Details on treatments following elacestrant therapy (Type of first subsequent systemic antineoplastic therapy)

Time frame: max. 24 months; from the patient-specific end of elacestrant treatment until end of study

Treatments following elacestrant therapy: Frequency of first subsequent systemic antineoplastic therapy

Details on treatments following elacestrant therapy:Frequency of first subsequent systemic antineoplastic therapy for ESR1mut patients (refers to first treatment received after Elacestrant so starting from third line)

Time frame: max. 24 months; from the patient-specific end of elacestrant treatment until end of study