A Study to Assess the Effectiveness of Trastuzumab Deruxtecan in Chinese Breast Cancer Patients (REFRESH)

Официальное название

A Multi-center Prospective Observational Study to Assess the Effectiveness and Safety of Trastuzumab Deruxtecan in Chinese Breast Cancer Patients (REFRESH)

Обзор

This multi-center observational prospective study will collect real-world clinical and patient-reported outcome data from eligible patients with unresectable or metastatic HER2+ breast cancer who have received one or more prior anti-HER2-based regimens or patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+, ISH-) breast cancer who have received at least a prior systemic therapy in the metastatic setting, or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.

Подробное описание

The primary objective of the study is to evaluate real-world time to next treatment or date of death from index date (T-DXd treatment initiation date)(rwTTNT) in each cohort. The secondary objectives of this study are to describe treatment patterns in eligible patients with HER2+ or HER2-low unresectable or mBC who are newly initiating T-DXd in a real-world setting, to describe demographic and clinical characteristics, to assess the safety and tolerability through the collection of physician-reported SEIs, to characterize the management of SEIs, to evaluate real-world time to treatment discontinuation (rwTTD) of T-DXd, and to evaluate patient-reported tolerability.

This decision to treat the patient with T-DXd will be made prior to, and independent of, their participation in this study. Eligible patients willing to participate will be enrolled consecutively in the study and followed up from index date (T-DXd treatment initiation date) until end of study, death, or withdrawal of consent, or loss to follow-up (LTFU), or study closure, whichever occurs first.

Вмешательства

• Препарат Trastuzumab deruxtecan
  Intravenous infusion

Первичные конечные точки

• Real World Time to Next Treatment (rwTTNT) in Participants With HER2-positive and HER2-low Unresectable or Metastatic Breast Cancer [Срок оценки: Assessed over a 36-month period]

Вторичные конечные точки (10)

• Change in T-DXd Dosing in Participants With HER2-positive and HER2-low Unresectable or Metastatic Breast Cancer [Срок оценки: Assessed over a 36-month period]
• Duration of Treatment (DoT) in Participants With HER2-positive and HER2-low Unresectable or Metastatic Breast Cancer [Срок оценки: Assessed over a 36-month period]
• Change in Dose Amendment in Participants With HER2-positive and HER2-low Unresectable or Metastatic Breast Cancer [Срок оценки: Assessed over a 36-month period]
• Percentage of Participants With HER2-positive and HER2-low Unresectable or Metastatic Breast Cancer, Based on Demographic and Clinical Characteristics [Срок оценки: Assessed over a 36-month period]
• Number of Participants Reporting Physician-reported Safety Events of Interest (SEI) in Participants With HER2-positive and HER2-low Unresectable or Metastatic Breast Cancer [Срок оценки: Assessed over a 36-month period]
• Number of Participants Reporting Prophylactic and Reactive Treatment for SEI Management [Срок оценки: Assessed over a 36-month period]
• Real-world Time to Discontinuation (rwTTD) in Participants With HER2-positive and HER2-low Unresectable or Metastatic Breast Cancer [Срок оценки: Assessed over a 36-month period]
• Change in Patient's Global Impression of Treatment Tolerability in Participants With HER2-positive and HER2-low Unresectable or Metastatic Breast Cancer [Срок оценки: Baseline up to 1 month post-T-DXd treatment]
• Number of Participants Reporting Symptom Items From National Cancer Institute Patient Reported Outcome Common Terminology Criteria for Adverse Events [Срок оценки: Baseline up to 1 month post-T-DXd treatment]
• Number of Participants Reporting Nausea and Vomiting Based on Symptom Diary Data [Срок оценки: Baseline up to 1 month post-T-DXd treatment]

Критерии участия

Patients must meet all of the following inclusion criteria to be eligible for the study:

• ≥18 years of age at time of consent.
• Pathologically documented breast cancer that is unresectable or metastatic.
• Cohort A: Patients with confirmed HER2+ (IHC 3+ or IHC2+, ISH+); and patients have received one or more prior anti-HER2-based regimens; and patients should have received no more than 2 lines therapy in the metastatic settings.

Cohort B: Patients with confirmed HER2-low expression (IHC 1+ or IHC 2+, ISH-); and patients have received at least a prior systemic therapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy; and patients should have received no more than 2 lines of previous chemotherapy regimen in the metastatic settings.

• Decision to newly initiate T-DXd or just have started the first dose no longer than 14 days after the index date per approved label in China.
• Capable of providing informed consent.
• Patients capable of completing questionnaires are preferred. If the participant is unable to complete the questionnaire (e.g., being blind, illiterate, not fluent in the available language, or ePRO system is not ready), that participant is exempted from completing PRO questionnaires but may still participate in the study.

Patients who meet any of the following criteria will be excluded from the study:

• Pregnancy or breastfeeding.
• Patients who at time of data collection for this study are participating in or have participated in an interventional study that remains blinded.
• Patients who have known to have hypersensitivity reactions to the active substance of T-DXd or any excipients.
• Patients who have been judged by the investigator to be unfit to participate the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 54 центра

• China-Japan Friendship Hospital — Пекин
• Peking University First Hospital — Пекин
• The Fifth Medical Center of the Chinese PLA General Hospital — Пекин
• Peking University Shougang Hospital — Пекин
• Peking University Third Hospital — Пекин
• Beijing GoBroad Hospital — Пекин
• Sichuan Cancer Hospital — Чэнду
• Sichuan Provincial People's Hospital — Чэнду
• … и ещё 46 центров

Идентификаторы

NCT: NCT06210776 · DSCN-EHT-NIS-BC002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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