Efficacy and Safety of Trastuzumab Rezetecan or Trastuzumab Deruxtecan in Advanced Breast Cancer (NCT07630103) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Efficacy and Safety of Trastuzumab Rezetecan or Trastuzumab Deruxtecan in Advanced Breast Cancer
China100 participantsStarted 2026-06
Plain-language summary
This study is a prospective, open-label, multicenter, randomized, parallel Phase II clinical trial. This study aims to investigate the efficacy and safety of trastuzumab rezetecan or trastuzumab deruxtecan in HER2 positive advanced/metastastic breast cancer
Who can participate
Age range
18 Years – 75 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female patients aged ≥18 and ≤75 years.
* Histologically or cytologically confirmed HER2-positive (IHC 3+ and/or ISH positive) unresectable or metastatic breast cancer.
* Prior treatment with trastuzumab and a taxane in the recurrent or metastatic setting. Or recurrence during or within 12 months (disease-free interval, DFI) after completing neoadjuvant/adjuvant chemotherapy and/or anti-HER2 targeted therapy.
* Documented radiological disease progression (during or after the most recent prior therapy).
* ECOG Performance Status of 0 or 1.
* At least one measurable lesion according to RECIST v1.1 criteria.
* Adequate organ function meeting the following criteria (without the use of any blood components, cytokines, or growth factors for correction within 14 days prior to the first dose):
Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L; Platelet count (PLT) ≥100 × 10⁹/L; Hemoglobin (Hb) ≥90 g/L (9.0 g/dL); Albumin ≥3.0 g/dL;Total bilirubin ≤1.5 × ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN (≤5.0 × ULN for patients with liver metastases); Serum creatinine ≤1.5 × ULN OR creatinine clearance ≥60 mL/min (calculated using the Cockcroft-Gault formula); QTcF interval ≤470 ms; Left ventricular ejection fraction (LVEF) ≥50% as measured by echocardiography (ECHO) or multigated acquisition scan (MUGA)
* Female subjects of childbearing potential must have a negative pregnancy test at screening and must agree to use highly effecti…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Progression Free Survival(PFS)
Timeframe: From the date of randomization to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, up to approximately 3 years
Trial details
NCT IDNCT07630103
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University