Assessing Trastuzumab Deruxtecan in Chinese Patients with HER2-positive and HER2-low Breast Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to collect real-world clinical and patient-reported outcome data from Chinese patients with unresectable or metastatic HER2-positive or HER2-low breast cancer who have received prior anti-HER2 treatments. The primary goal is to evaluate the time to next treatment or date of death following the initiation of Trastuzumab Deruxtecan (T-DXd). Secondary objectives include analyzing treatment patterns, demographic and clinical characteristics, safety and tolerability, and time to treatment discontinuation. Patients will be followed from the initiation of T-DXd until the end of the study or until they withdraw consent or are lost to follow-up.

Why it matters

Who can join: the full rules

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

1. ≥18 years of age at time of consent.
2. Pathologically documented breast cancer that is unresectable or metastatic.
3. 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.
4. 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.
5. Capable of providing informed consent.
6. 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:

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

Where it's running

• China-Japan Friendship Hospital
  Beijing, China Recruiting
• Peking University First Hospital
  Beijing, China Recruiting
• Peking University Shougang Hospital
  Beijing, China Recruiting
• Peking University Third Hospital
  Beijing, China Recruiting
• Beijing GoBroad Hospital
  Beijing, China Recruiting
• Sichuan Cancer Hospital
  Chengdu, China Recruiting

+4 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Daiichi Sankyo China
• Email: yu.huan.m8@daiichisankyo.com.cn
• Phone: 0086-021-60397406

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.