HER2-Low Unresectable/Metastatic Breast Cancer Complicated With Visceral CrisisPhase 2NCT07203729
The Efficacy and Safety of Trastuzumab Rezetecan (SHR-A1811) in HER2-Low Unresectable/Metastatic Breast Cancer Patients With Visceral Crisis
A Phase 2 study testing Trastuzumab Rezetecan and Chemotherapy of Physician's Choice in people with HER2-Low Unresectable/Metastatic Breast Cancer Complicated With Visceral Crisis, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- HER2-Low Unresectable/Metastatic Breast Cancer Complicated With Visceral Crisis
- What is being tested?
- Trastuzumab Rezetecan and Chemotherapy of Physician's Choice
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2026to 30 Dec 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: ≥18 years old and ≤75 years old;
- Pathologically confirmed HER2-Low unresectable or metastatic breast cancer;
- Investigator-assessed visceral crisis. Visceral crisis includes clinical crisis and molecular crisis. Subjects must meet the criteria for either clinical crisis or molecular crisis.
- Clinical 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.
- Molecular crisis is defined as a baseline monocyte-derived cfDNA fraction < 0.0581, as determined by cell-specific cfDNA methylation analysis of the patient's baseline plasma sample. All patients undergoing screening must provide plasma samples for cfDNA methylation testing.
- Patients whom investigators deem to have indications for single-agent chemotherapy.
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- 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 ≤ 3 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 be performed within 7 days before the first dose of study drug, with a negative result. They must agree to either abstain from sexual activity or use a medically approved highly effective contraceptive method from the time of signing the informed consent form, throughout the study period, and for 1 year after the last dose of study drug.
- Patients must voluntarily participate in this study, sign the informed consent form, have good compliance, and be willing to cooperate with follow-up.
Who cannot join
- Have received treatment with new antibody-drug conjugates (ADCs) at any stage of breast cancer.
- Are deemed by the investigator as unsuitable for systemic chemotherapy.
- Have had other malignant tumors within the past 5 years, excluding cured carcinoma in situ of the cervix, cutaneous basal cell carcinoma, or cutaneous squamous cell carcinoma (patients with other malignant tumors that occurred more than 5 years before randomization and were cured solely by surgery are eligible for enrollment).
- Have undergone major surgical procedures or suffered significant trauma within 4 weeks prior to randomization, or are expected to undergo major surgical treatment.
- Have severe heart disease or cardiac discomfort, including but not limited to the following conditions：a) A history of heart failure or systolic dysfunction (left ventricular ejection fraction [LVEF] < 50%)；b) High-risk angina pectoris requiring treatment or cardiac arrhythmias；c) Clinically significant valvular heart disease；d) ECG findings indicating transmural myocardial infarction；e) Poorly controlled hypertension.
- Have a known history of allergy to any component of the drugs in this protocol.
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- Have a history of immunodeficiency, including HIV infection, or other acquired or congenital immunodeficiency diseases.
- Have a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Have a known history of psychotropic substance abuse or drug addiction.
- Are pregnant or lactating women, or women of childbearing age who are unwilling to use effective contraceptive measures throughout the trial period and within 7 months after the last administration of the study drug.
- Have severe diseases, other comorbidities that would interfere with the planned treatment, or any other conditions that make them unsuitable for participation in this study (e.g., active hepatitis B, pulmonary infection requiring treatment).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Fei Ma M.D, 01087788060, drmafei@126.com
About this study
Official title: Trastuzumab Rezetecan (SHR-A1811) Versus Chemotherapy of Physician's Choice in Patients With HER2-Low Unresectable/Metastatic Breast Cancer Complicated With Visceral Crisis：A Randomized, Prospective, Open-Label Phase II Trial.
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.
- Being tested
- Trastuzumab Rezetecan, Chemotherapy of Physician's Choice
- Keywords
- HER2-Low unresectable/metastatic breast cancer, Visceral Crisis, Antibody drug conjugates, Trastuzumab Rezetecan
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trastuzumab RezetecanDrug
Trastuzumab Rezetecan 4.8mg/kg, IV, Day 1, Q3W
Chemotherapy of Physician's ChoiceDrug
Also called nab-paclitaxel, Eribulin, Capecitabine, Vinorelbine
Chemotherapy of Physician's Choice, including nab-paclitaxel, Eribulin, Capecitabine, Vinorelbine, Gemcitabine.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1：Trastuzumab Rezetecan | Experimental | Not described Receives: Drug: Trastuzumab Rezetecan |
| Arm 2：Chemotherapy of Physician's Choice | Active comparator | Not described Receives: Drug: Chemotherapy of Physician's Choice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
Progression-Free Survival is defined as the time from randomization to first documented disease progression (PD) using Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) or death from any cause, whichever occurred first. The PFS will be will be estimated using Kaplan-Meier method. A Kaplan-Meier curve, median PFS, hazard ratio with appropriate confidence intervals will be reported.
Measured: From the start of treatment to 36 month
Secondary outcomes (4)
Clinical Benefit Response (CBR)
CBR is percentage of participants with best (confirmed) PR or CR or SD for at least 6 months. PR or CR or SD is according to RECIST version 1.1. The CBR will be reported by percentage with each arms and appropriate confidence intervals.
Measured: From the start of treatment to 36 month
Objective Overall Response Rate (ORR)
ORR is defined as percentage of participants with best (confirmed) overall response (BOR) of either CR or PR. ORR was assessed by the investigator according to RECIST version 1.1 and is based on BOR, which is defined as best response recorded from start of study treatment until disease progression/recurrence or death. The ORR will be reported by percentage with each arms and appropriate confidence intervals.
Measured: From the start of treatment to 36 month
Overall Survival (OS)
Overall Survival , defined as the time from the start of treatment to the date of death, regardless of the cause of death. The OS will be estimated using Kaplan-Meier method. A Kaplan-Meier curve, median OS, hazard ratio with appropriate confidence intervals will be reported.
Measured: From the start of treatment to 36 month
Adverse events (AEs)
AEs were graded according to the National Cancer Institute's Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0. The type, grade and frequency of AEs will be reported.
Measured: From the start of treatment to 36 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start1 Mar 2026
- Primary completion15 Jun 2030 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-Low Unresectable/Metastatic Breast Cancer Complicated With Visceral CrisisStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ma Fei，MD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07203729
- Sponsor's protocol ID
- MA-BC-II-117
- Status last verified
- Sep 2026
- First submitted
- 25 Sep 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trastuzumab Rezetecan (SHR-A1811) Versus Chemotherapy of Physician's Choice in Patients With HER2-Low Unresectable/Metastatic Breast Cancer Complicated With Visceral Crisis：A Randomized, Prospective, Open-Label Phase II Trial.
- ClinicalTrials.gov ID
- NCT07203729
- Acronym / sponsor ID
- MA-BC-II-117
- Keywords
- HER2-Low unresectable/metastatic breast cancer, Visceral Crisis, Antibody drug conjugates, Trastuzumab Rezetecan
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 15 Jun 2030 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 2 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1：Trastuzumab Rezetecan | Experimental | Drug: Trastuzumab Rezetecan |
| Arm 2：Chemotherapy of Physician's Choice | Active comparator | Drug: Chemotherapy of Physician's Choice |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age: ≥18 years old and ≤75 years old;
- Pathologically confirmed HER2-Low unresectable or metastatic breast cancer;
- Investigator-assessed visceral crisis. Visceral crisis includes clinical crisis and molecular crisis. Subjects must meet the criteria for either clinical crisis or molecular crisis.
- Clinical 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.
- Molecular crisis is defined as a baseline monocyte-derived cfDNA fraction < 0.0581, as determined by cell-specific cfDNA methylation analysis of the patient's baseline plasma sample. All patients undergoing screening must provide plasma samples for cfDNA methylation testing.
Key exclusion criteria (11 listed)
- Have received treatment with new antibody-drug conjugates (ADCs) at any stage of breast cancer.
- Are deemed by the investigator as unsuitable for systemic chemotherapy.
- Have had other malignant tumors within the past 5 years, excluding cured carcinoma in situ of the cervix, cutaneous basal cell carcinoma, or cutaneous squamous cell carcinoma (patients with other malignant tumors that occurred more than 5 years before randomization and were cured solely by surgery are eligible for enrollment).
- Have undergone major surgical procedures or suffered significant trauma within 4 weeks prior to randomization, or are expected to undergo major surgical treatment.
- Have severe heart disease or cardiac discomfort, including but not limited to the following conditions：a) A history of heart failure or systolic dysfunction (left ventricular ejection fraction [LVEF] < 50%)；b) High-risk angina pectoris requiring treatment or cardiac arrhythmias；c) Clinically significant valvular heart disease；d) ECG findings indicating transmural myocardial infarction；e) Poorly controlled hypertension.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trastuzumab RezetecanTrastuzumab Rezetecan 4.8mg/kg, IV, Day 1, Q3W | Drug | Arm 1：Trastuzumab Rezetecan |
| Chemotherapy of Physician's ChoiceAlso: nab-paclitaxel, Eribulin, Capecitabine, VinorelbineChemotherapy of Physician's Choice, including nab-paclitaxel, Eribulin, Capecitabine, Vinorelbine, Gemcitabine. | Drug | Arm 2：Chemotherapy of Physician's Choice |
Primary outcome
Progression-Free Survival (PFS)
Time frame: From the start of treatment to 36 month
Progression-Free Survival is defined as the time from randomization to first documented disease progression (PD) using Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) or death from any cause, whichever occurred first. The PFS will be will be estimated using Kaplan-Meier method. A Kaplan-Meier curve, median PFS, hazard ratio with appropriate confidence intervals will be reported.
4 secondary outcomes
Clinical Benefit Response (CBR)
Time frame: From the start of treatment to 36 month
Objective Overall Response Rate (ORR)
Time frame: From the start of treatment to 36 month
Overall Survival (OS)
Time frame: From the start of treatment to 36 month
Adverse events (AEs)
Time frame: From the start of treatment to 36 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trastuzumab Rezetecan and Chemotherapy of Physician's Choice in people with HER2-Low Unresectable/Metastatic Breast Cancer Complicated With Visceral Crisis, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: From the start of treatment to 36 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.