Tucatinib in Patients With Locally Advanced or Metastatic HER2-positive Breast Cancer Who Received at Least Two Prior Anti-HER2 Treatment Regimens: a Multicenter, International, Prospective, Non-interventional Study in Germany and Austria (TRACE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- iOMEDICO AG
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Changes in the global health scale
研究概览
简要总结
The objective of this non-interventional study (NIS) is to evaluate tucatinib (TUKYSA®) combined with trastuzumab and capecitabine in adult patients with locally advanced or metastatic HER2-positive breast cancer who have been previously treated with at least two anti-HER2 treatment regimens in a real-world setting,
详细描述
TRACE will collect real-world data on the treatment of tucatinib/trastuzumab/capecitabine in a broad patient population including older patients and patients with more comorbidities as compared to the pivotal trial HER2CLIMB. In contrast to HER2CLIMB, TRACE will also include patients receiving tucatinib/trastuzumab/capecitabine during 1st and 2nd palliative therapy line who were primarily diagnosed with early breast cancer and therefore already have received two prior anti-HER2 based treatment regimens before enrollment. Until today, no reliable data is available for these patient population. TRACE will primarily focus on HRQoL using the validated EORTC QLQ C30 + QLQ-BR23 + EQ-5D-5L questionnaires. Further aims are to evaluate effectiveness and safety in distinct subgroups focusing on effectiveness of tucatinib/trastuzumab/capecitabine in patients who have experienced prior therapies with trastuzumab and neratinib or capecitabine and HER2-targeted TKIs in the neoadjuvant, adjuvant or palliative setting, respectively.
Study sites may retrospectively include patients within 9 weeks (corresponds to 3 cycles) after start of study treatment up to 6 months after activation of respective site. Retrospectively included patients may have already completed study treatment or may have already deceased at the time of inclusion.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or older.
- •Histologically confirmed HER2+ breast cancer with HER2 positivity defined as a 3+ score by immunohistochemistry (IHC) or a positive result by in situ hybridization (ISH), optionally combined with a IHC2+ score.
- •Diagnosis of locally advanced or metastatic HER2+ breast cancer, including patients with brain metastases.
- •Prior treatment with at least two prior anti-HER2-based regimens.
- •Decision for treatment with tucatinib in combination with trastuzumab and capecitabine according to current SmPC of tucatinib either in
- •1st/2nd palliative treatment line (Cohort 1) or 3rd/4th palliative treatment line (Cohort 2).
- •Progression after or intolerance of last systemic anti-HER2-based therapy.
- •Indication for treatment with tucatinib as assessed by the treating physician.
- •Signed written informed consent (only if patient is alive at time of inclusion, not applicable for retrospective inclusion of deceased patients).
- •Knowledge of German language.
- •Other criteria according to current SmPC of tucatinib
排除标准
- •Contraindications according to SmPC of tucatinib
- •Participation in an interventional clinical trial within 30 days prior to enrolment or simultaneous participation in an interventional clinical trial.
- •Treatment with tucatinib/trastuzumab/capecitabine (=study treatment) in 5th or higher palliative therapy line.
- •Onset of tucatinib treatment later than 22 days after start of therapy line (in case tucatinib administration is started later than trastuzumab and/or capecitabine for any reason)
研究组 & 干预措施
Cohort 1
Patients receiving tucatinib/trastuzumab/capecitabine (=study treatment) in 1st or 2nd palliative therapy line.
干预措施: TUKYSA® (Drug)
Cohort 2
Patients receiving tucatinib/trastuzumab/capecitabine (=study treatment) in 3rd or 4th palliative therapy line.
干预措施: TUKYSA® (Drug)
结局指标
主要结局
Changes in the global health scale
时间窗: Baseline, up to 24 months
Only for prospectively enrolled patients: Changes in global health is provided by descriptive statistics of the EQ-5D-5L index value, the EQ-5D-5L visual analogue scale, the EORTC QLQ-C30 global health scale and all functional and symptom scores of the EORTC questionnaires.
Time to deterioration of EORTC global health scale by at least 10 points
时间窗: Baseline, up to 24 months
Only for prospectively enrolled patients: Time to deterioration of EORTC global health scale is defined as the time interval between fill-in date of baseline questionnaire and the first decrease in global health scale score ≥ 10-point (compared to baseline). If there was no such decrease, death will serve as event for this analysis, if occurring within 4 months after last filled-in questionnaire.
次要结局
- Time to next systemic treatment (TTNT)(Baseline, up to 5 years)
- Time to local intracranial treatment (TLT)(Baseline, up to 5 years)
- Duration of response (DOR)(Baseline, up to 5 years)
- Overall response rate (ORR)(Baseline, up to 5 years)
- Clinical benefit rate (CBR)(Baseline, up to 5 years)
- Treatment Duration(Baseline, up to 5 years)
- Adverse events (AEs) and serious adverse events (SAEs) according to NCI CTCAE(Baseline, up to 30 days after end of tucatinib treatment)
- Safety laboratory value: bilirubin(Baseline, up to 30 days after end of tucatinib treatment)
- Therapy decision making(Baseline)
- Previous antineoplastic Therapies(Baseline)
- Previous anti-HER2 regimens(Baseline)
- Safety laboratory value: Aspartate aminotransferase (AST)(Baseline, up to 30 days after end of tucatinib treatment)
- Safety laboratory value: Alanine aminotransferase (ALT)(Baseline, up to 30 days after end of tucatinib treatment)
- Subsequent antineoplastic therapies(End of treatment, up to 5 years)
- Local antineoplastic therapies(Baseline, up to 5 years)
- Details on line of treatment for both cohorts(Baseline)
- Dose intensity(Baseline, up to 5 years)
- Dose modifications(Baseline, up to 5 years)
- Therapy management (use of relevant supportive medications)(Baseline, up to 5 years)