The Efficacy and Safety of Trastuzumab Rezetecan (SHR-A1811) in HER2-Low Unresectable/Metastatic … (NCT07203729) | Clinical Trial Compass
RecruitingPhase 2
The Efficacy and Safety of Trastuzumab Rezetecan (SHR-A1811) in HER2-Low Unresectable/Metastatic Breast Cancer Patients With Visceral Crisis
China184 participantsStarted 2026-03-01
Plain-language summary
The goal of this clinical trial is to learn if Trastuzumab Rezetecan (SHR-A1811) is safe and tolerable for patients with HER2-Low unresectable/metastatic breast cancer complicated with visceral crisis. Participants will take Trastuzumab Rezetecan every three weeks, until disease progression or intolerable toxicity.
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:
* Age: ≥18 years old and ≤75 years old;
* Pathologically confirmed HER2-Low unresectable or metastatic breast cancer;
* Visceral crisis is defined as severe organ dysfunction as assessed by signs, symptoms and laboratory studies, resulting from rapid progression of neoplastic disease and indicative of substantial visceral compromise that may serve as an indication for more aggressive therapeutic intervention, including:a)Liver visceral crisis: rapidly increasing bilirubin \>1.5 × ULN in the absence of Gilbert's syndrome or biliary tract obstruction;b)Lung visceral crisis: rapidly increasing dyspnoea at rest, not alleviated by drainage of pleural effusion;c)Other visceral crises: the evaluation is conducted by the clinician based on the definition of visceral crisis specified in the ABC7 guideline.
* Patients whom investigators deem to have indications for single-agent chemotherapy.
* Sufficient bone marrow function, defined as follows:a) Neutrophil count (ANC) ≥ 1,500/mm³ (1.5 × 10⁹/L);b) Platelet count (PLT) ≥ 80 ×10\^9/L;c) Hemoglobin (Hb) ≥ 80 g/L;
* Patients who have received ≤ 1 line of chemotherapy in the advanced stage are permitted.
* Patients who have received endocrine therapy in the advanced stage are permitted.
* Previous treatment with CDK4/6 inhibitors is permitted.
* Previous or concurrent local treatment for symptom relief is permitted.
* For female subjects who are premenopausal or not surgically sterilized:
A serum pregnancy test must b…
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 start of treatment to 36 month
Trial details
NCT IDNCT07203729
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences