Real-World Research of Treatment Patterns and Treatment Adherence in Early HER2-positive Breast Cancer in Serbia After Treatment Decentralization (Close2HER)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 10
- 主要终点
- Treatment Adherence Rate
研究概览
简要总结
The main purpose of this study is to evaluate the impact of a decentralized treatment model on treatment adherence in participants with early-stage human epidermal growth factor receptor 2- positive (HER2+) breast cancer (BC).
This study has 2 groups: Group 1: Consistent Travel Burden (Cohorts A, C, and D), will include participants whose adjuvant therapy location does not increase their travel requirements, and Group 2: Increased Travel Burden (Cohort B), will include participants who must travel from a secondary center to a tertiary center to receive their adjuvant therapy.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of stage II and III HER2+ eBC according to European Society For Medical Oncology (ESMO) guidelines
- •Underwent curative-intent surgical resection for BC
- •Histologically documented HER2-positive BC (determined per American Society of Clinical Oncology [ASCO]/College of American Pathologists [CAP] guidelines) before or after surgery
排除标准
- •Any medical or psychiatric condition that, in the investigator's opinion, would compromise the participant's ability to provide informed consent or to complete study-related questionnaires
- •Receipt of prior neoadjuvant or adjuvant therapy for HER2+ BC at a center other than the 10 participating study sites (Bor, Kladovo, Institute for oncology and Radiology of Serbia (IORS), Loznica, Pančevo, Požarevac, Smederevo, Smederevska Palanka, Šabac, Valjevo)
- •Participants administratively belonging to the following secondary centers: Bor, Kladovo, Loznica, Pančevo, Požarevac, Smederevo, Smederevska Palanka, Šabac, or Valjevo, who initiated neoadjuvant therapy at IORS instead of their local secondary center
研究组 & 干预措施
Group 2: Cohort B
Participants who received neoadjuvant therapy at a secondary center and were subsequently found to have residual invasive disease will be referred to a centralized referent tertiary institution to receive their adjuvant treatment and will be observed to assess the impact on QoL and travel burden. All treatment decisions will be made at the discretion of the treating physician and participant, reflecting routine clinical practice without any study-mandated interventions.
Group 1: Cohort A
Participants who received neoadjuvant therapy and achieved pathological complete response (pCR) and receive their adjuvant treatment at a designated secondary or tertiary center, administratively assigned based on their place of residence will be observed to assess the impact on quality of life (QoL) and travel burden. All treatment decisions will be made at the discretion of the treating physician and participant, reflecting routine clinical practice without any study-mandated interventions.
Group 1: Cohort D
Participants who missed neoadjuvant therapy and underwent primary BC surgery will start adjuvant treatment at their designated secondary hospital or tertiary center, which is the institution administratively assigned based on their place of residence and will be observed to assess the impact on QoL and travel burden. All treatment decisions will be made at the discretion of the treating physician and participant, reflecting routine clinical practice without any study-mandated interventions.
Group 1: Cohort C
Participants who received neoadjuvant therapy at their designated tertiary center, which is the institution administratively assigned based on their place of residence, and subsequently found to have residual invasive disease will continue with adjuvant treatment at the same institution, and will be observed to assess the impact on QoL and travel burden. All treatment decisions will be made at the discretion of the treating physician and participant, reflecting routine clinical practice without any study-mandated interventions.
结局指标
主要结局
Treatment Adherence Rate
时间窗: Up to 2.25 years
次要结局
- Treatment Completion Rate for Anti-HER2 Treatment(Up to 2.25 years)
- Percentage of Participants With ≥1 Dose Delays Exceeding a Pre-defined Threshold (3 Weeks) From the Scheduled Date(Up to 2.25 years)
- Mean Travel Burden Between Group 1 (Cohorts A, C, D) and Group 2 (Cohort B) During the Adjuvant Therapy Phase(Up to 2.25 years)
- Cohort B: Change in Intra-participant Travel Burden Between the Neoadjuvant and Adjuvant Treatment Centers(Up to 2.25 years)
- Difference in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Global Health Status (GHS)/QoL Score, Between Participants of Cohort B and Cohort C(At 6 months post-baseline)
- Mean Intra-patient Change in the EORTC QLQ-C30 GHS/QoL Score(Cohorts A, B and C: Baseline to Month 6; Cohort D: Month 6 to Month 12)
- Time to Neoadjuvant Treatment Initiation(At Baseline)
- Time to Surgery(At Baseline)
- Time to Adjuvant Treatment Initiation(Time from surgery to the start of adjuvant treatment (up to approximately 1.25 years))
- Percentage of Participants Treated at Least Once With Neoadjuvant Therapy(At Baseline)
- Percentage of Participants Not Treated With Neoadjuvant Therapy(At Baseline)
- Percentage of Participants With pCR After Neoadjuvant Systemic Therapy Completion(At Baseline)