NCT07563595招募中不适用
Elacestrant in Patients With ER+ HER2- ESR1-mutated Locally Advanced or Metastatic Breast Cancer: a Multicenter, National, Prospective Non-interventional Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- iOMEDICO AG
- 入组人数
- 500
- 试验地点
- 3
- 主要终点
- Change from baseline in EORTC global health scale
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
ESR1 wildtype
Patients with a ESR1 wildtype tumor
干预措施: Standard of care (Investigator Choice) (Drug)
ESR1 mutated
Patients with a ESR1 mutated tumor
干预措施: Elacestrant (Drug)
结局指标
主要结局
Change from baseline in EORTC global health scale
时间窗: 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.
次要结局
- Time to deterioration in global health scale (EORTC QLQ-C30)(From Time of enrollment until month 11)
- Time to deterioration in functional scores (EORTC QLQ-C30)(From Time of enrollment until month 11)
- Time to deterioration in symptom scores (EORTC QLQ-C30)(From Time of enrollment until month 11)
- Change from baseline in functional and symptom scores(From Time of enrolment until up to 11 months after enrolment.)
- Change from baseline in visual analogue scale (VAS)(From Time of enrollment until month 11.)
- Change from baseline in index value(From Time of enrollment until month 11.)
- Change from baseline in all scales of EQ-5D-5L(From Time of enrollment until month 11.)
- Prevalence of ESR1 mutation(Baseline)
- Drug safety: Frequency(From time of treatment start until 30 days after end of elacestrant treatment)
- Drug safety: Incidence of adverse events(From time of treatment start until 30 days after end of elacestrant treatment)
- Drug safety: Change from baseline in AST (Aspartate Aminotransferase)(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)(From time of treatment start until 30 days after end of elacestrant treatment (max. 24 months))
- Drug safety: Change from baseline in bilirubin(From time of treatment start until 30 days after end of elacestrant treatment (max. 24 months))
- Patients and disease characteristics: Age(Baseline)
- Patients and disease characteristics: Body mass index (BMI)(Baseline)
- Patients and disease characteristics: ECOG Performance status(Baseline)
- Patients and disease characteristics: CCI (Charlson score and contributing diseases)(Baseline)
- Patients and disease characteristics: Time since diagnosis(Baseline)
- Patients and disease characteristics: TNM staging(Baseline)
- Patients and disease characteristics: Metastatic sites(Baseline)
- Patients and disease characteristics: Tumor Grading(Baseline)
- Patients and disease characteristics: HR and HER2 status(Baseline)
- Patients and disease characteristics: Prior adjuvant chemotherapy(Baseline)
- Patients and disease characteristics: Prior adjuvant endocrine therapy(Baseline)
- Patients and disease characteristics: prior CDKi/endocrine therapy in the palliative setting(Baseline)
- Patients and disease characteristics: Disease site(At time of enrollment)
- Patients and disease characteristics: concomitant diseases(Baseline)
- Use of concomitant medication(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(Baseline)
- Frequency of first subsequent systemic antineoplastic therapy for ESR1wt patients and ESR1mut patients without elacestrant treatment(max. 24 months; at patient patient-specific start of treatment)
- Details on treatment with elacestrant: reason for end of treatment(max. 24 months; from the patient-specific study start to end of study (during elacestrant treatment))
- Details on treatment with elacestrant: dose intensity(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(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(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(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(max. 24 months; from the patient-specific end of elacestrant treatment until end of study)
研究者
研究点 (3)
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