Unresectable Locally Recurrent Breast CancerPhase 2NCT07497386
A Trial of Trastuzumab Rezetecan in Unresectable Locally Recurrent/Metastatic Breast Cancer
A Phase 2 study testing Trastuzumab Rezetecan for Injection and Trastuzumab Deruxtecan for Injection in people with Unresectable Locally Recurrent Breast Cancer and Unresectable Locally Metastatic Breast Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The study is designed to compare the efficacy and safety of different dose groups of Trastuzumab Rezetecan or Trastuzumab Deruxtecan in patients with HR-positive, HER2-low unresectable locally recurrent/metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Unresectable Locally Recurrent Breast Cancer, Unresectable Locally Metastatic Breast Cancer
- What is being tested?
- Trastuzumab Rezetecan for Injection and Trastuzumab Deruxtecan for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 28 Apr 2026to Dec 2028
- 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
- Female aged 18 to 75 years (inclusive).
- Unresectable locally recurrent or metastatic breast cancer.
- Prior therapy must meet the following: No prior chemotherapy for recurrent/metastatic disease. Must have received at least one prior line of endocrine therapy for recurrent/metastatic disease with disease progression, and the investigator judges that further benefit from endocrine therapy is not possible.
- Documented radiological disease progression (during or after the most recent therapy).
- ECOG performance status of 0 or 1.
- Life expectancy ≥ 12 weeks.
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- At least one extracranial measurable lesion as a target lesion according to RECIST v1.1 criteria.
- Adequate function of major organs.
- Pregnancy and contraception: Women of childbearing potential (WOCBP) must agree to use highly effective contraception from study screening until 7 months after the last dose of study drug and agree not to breastfeed; serum pregnancy test result must be negative within 7 days before the first dose.
- The patient voluntarily participates in this study, signs the informed consent form, has good compliance, and is willing to cooperate with visits and study-related procedures.
Who cannot join
- Presence of leptomeningeal metastasis/carcinomatous meningitis, spinal cord compression, or active central nervous system metastases.
- Patients with only skin or brain lesions as target lesions.
- History of other malignancies within the past 5 years, except for cured basal cell carcinoma of the skin or carcinoma in situ of the cervix.
- Presence of carcinomatous lymphangitis, or third-space fluid accumulation that cannot be controlled by methods such as drainage.
- Prior surgery, chemotherapy, immunotherapy, or macromolecular targeted therapy within 4 weeks before the first dose; prior endocrine therapy, chemotherapy with 5-FU analogs, or radiotherapy within 2 weeks before the first dose; small molecule targeted agents require a washout period of 2 weeks or 5 half-lives; other investigational drugs require a washout period of 4 weeks or 5 half-lives before the first dose.
- Use of immunosuppressants or systemic corticosteroids for immunosuppressive purposes within 2 weeks before the first dose for therapeutic intent.
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- History of immunodeficiency, including a positive HIV test, other acquired or congenital immunodeficiency diseases, or history of organ transplantation.
- Clinically significant cardiovascular disease, such as severe/unstable angina, symptomatic congestive heart failure, etc.; clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention; myocardial infarction or cerebrovascular accident within 6 months before the first dose.
- Participants with known or suspected interstitial lung disease; other moderate-to-severe pulmonary diseases that may interfere with the detection or management of drug-related pulmonary toxicity and severely affect respiratory function within 3 months before the first dose; and any autoimmune, connective tissue, or inflammatory disorders with pulmonary involvement.
- Known hereditary or acquired bleeding tendency.
- Active hepatitis B, hepatitis C, or cirrhosis; or severe infection requiring control with antibiotics, antivirals, or antifungals.
- Toxicities from prior anti-tumor therapy have not recovered to ≤ Grade 1 (according to NCI-CTCAE v5.0).
- Any other severe physical or mental illness or laboratory abnormality that may increase the risk associated with study participation, interfere with study results, or any other condition for which the investigator considers the patient unsuitable for participation in this study.
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
Binghe Xu, +86-010-67781331, xubinghe@medmail.com.cn
Binghe Xu
About this study
Official title: A Randomized, Open-Label, Multicenter Phase II Clinical Study of Different Doses of Trastuzumab Rezetecan for Injection or Trastuzumab Deruxtecan for Injection in the Treatment of Unresectable Locally Recurrent/Metastatic Breast Cancer With HR-Positive and HER2-Low Expression
The study is designed to compare the efficacy and safety of different dose groups of Trastuzumab Rezetecan or Trastuzumab Deruxtecan in patients with HR-positive, HER2-low unresectable locally recurrent/metastatic breast cancer. It will also exploratively evaluate the pharmacokinetic profile and immunogenicity of Trastuzumab Rezetecan.
- Conditions
- Unresectable Locally Recurrent Breast Cancer, Unresectable Locally Metastatic Breast Cancer
- Being tested
- Trastuzumab Rezetecan for Injection, Trastuzumab Deruxtecan for Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trastuzumab Rezetecan for InjectionDrug
Trastuzumab Rezetecan for injection.
Trastuzumab Deruxtecan for InjectionDrug
Trastuzumab Deruxtecan for injection.
| Study group | Role | What they receive |
|---|---|---|
| Trastuzumab Rezetecan for Injection | Experimental | Trastuzumab Rezetecan for Injection, different doses. Receives: Drug: Trastuzumab Rezetecan for Injection |
| Trastuzumab Deruxtecan for Injection | Experimental | Not described Receives: Drug: Trastuzumab Deruxtecan for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS).
Measured: Every 6 weeks after administration, approximately 14 months.
Secondary outcomes (8)
Objective response rate (ORR).
Measured: Every 6 weeks after administration, approximately 14 months.
Duration of response (DoR).
Measured: Every 6 weeks after administration, approximately 14 months.
Clinical benefit rate (CBR).
Measured: Every 6 weeks after administration, approximately 14 months.
Adverse events (AEs).
Graded according to NCI-CTCAE version 5.0.
Measured: From the first dose administration until 40 days after the last dose administration.
Laboratory test indicators, including complete blood count.
Measured: From the first dose administration until 40 days after the last dose administration.
Laboratory test indicators, including urinalysis.
Measured: From the first dose administration until 40 days after the last dose administration.
Laboratory test indicators, including virology screening.
Measured: From the first dose administration until 40 days after the last dose administration.
Serum concentrations of Trastuzumab Rezetecan.
Measured: Until the end of treatment, approximately 14 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start28 Apr 2026
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable Locally Recurrent Breast CancerStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The 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
- Model description
- Different dose groups of Trastuzumab Rezetecan compared with Trastuzumab Deruxtecan.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07497386
- Sponsor's protocol ID
- SHR-A1811-217
- Status last verified
- May 2026
- First submitted
- 19 Mar 2026
- Last updated
- 11 May 2026
- Results posted
- No
- 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 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Multicenter Phase II Clinical Study of Different Doses of Trastuzumab Rezetecan for Injection or Trastuzumab Deruxtecan for Injection in the Treatment of Unresectable Locally Recurrent/Metastatic Breast Cancer With HR-Positive and HER2-Low Expression
- ClinicalTrials.gov ID
- NCT07497386
- Acronym / sponsor ID
- SHR-A1811-217
- Conditions
- Unresectable Locally Recurrent Breast Cancer, Unresectable Locally Metastatic Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Apr 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 27 Mar 2026 (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 study is designed to compare the efficacy and safety of different dose groups of Trastuzumab Rezetecan or Trastuzumab Deruxtecan in patients with HR-positive, HER2-low unresectable locally recurrent/metastatic breast cancer. It will also exploratively evaluate the pharmacokinetic profile and immunogenicity of Trastuzumab Rezetecan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Different dose groups of Trastuzumab Rezetecan compared with Trastuzumab Deruxtecan.
| Arm | Type | Receives |
|---|---|---|
| Trastuzumab Rezetecan for Injection | Experimental | Drug: Trastuzumab Rezetecan for InjectionTrastuzumab Rezetecan for Injection, different doses. |
| Trastuzumab Deruxtecan for Injection | Experimental | Drug: Trastuzumab Deruxtecan for Injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Female aged 18 to 75 years (inclusive).
- Unresectable locally recurrent or metastatic breast cancer.
- Prior therapy must meet the following: No prior chemotherapy for recurrent/metastatic disease. Must have received at least one prior line of endocrine therapy for recurrent/metastatic disease with disease progression, and the investigator judges that further benefit from endocrine therapy is not possible.
- Documented radiological disease progression (during or after the most recent therapy).
- ECOG performance status of 0 or 1.
Key exclusion criteria (13 listed)
- Presence of leptomeningeal metastasis/carcinomatous meningitis, spinal cord compression, or active central nervous system metastases.
- Patients with only skin or brain lesions as target lesions.
- History of other malignancies within the past 5 years, except for cured basal cell carcinoma of the skin or carcinoma in situ of the cervix.
- Presence of carcinomatous lymphangitis, or third-space fluid accumulation that cannot be controlled by methods such as drainage.
- Prior surgery, chemotherapy, immunotherapy, or macromolecular targeted therapy within 4 weeks before the first dose; prior endocrine therapy, chemotherapy with 5-FU analogs, or radiotherapy within 2 weeks before the first dose; small molecule targeted agents require a washout period of 2 weeks or 5 half-lives; other investigational drugs require a washout period of 4 weeks or 5 half-lives before the first dose.
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 Rezetecan for InjectionTrastuzumab Rezetecan for injection. | Drug | Trastuzumab Rezetecan for Injection |
| Trastuzumab Deruxtecan for InjectionTrastuzumab Deruxtecan for injection. | Drug | Trastuzumab Deruxtecan for Injection |
Primary outcome
Progression-free survival (PFS).
Time frame: Every 6 weeks after administration, approximately 14 months.
8 secondary outcomes
Objective response rate (ORR).
Time frame: Every 6 weeks after administration, approximately 14 months.
Duration of response (DoR).
Time frame: Every 6 weeks after administration, approximately 14 months.
Clinical benefit rate (CBR).
Time frame: Every 6 weeks after administration, approximately 14 months.
Adverse events (AEs).
Time frame: From the first dose administration until 40 days after the last dose administration.
Laboratory test indicators, including complete blood count.
Time frame: From the first dose administration until 40 days after the last dose administration.
Laboratory test indicators, including urinalysis.
Time frame: From the first dose administration until 40 days after the last dose administration.
Laboratory test indicators, including virology screening.
Time frame: From the first dose administration until 40 days after the last dose administration.
Serum concentrations of Trastuzumab Rezetecan.
Time frame: Until the end of treatment, approximately 14 months.
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 11 May 2026.
- Individual participant dataSharing planned: Undecided
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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 for Injection and Trastuzumab Deruxtecan for Injection in people with Unresectable Locally Recurrent Breast Cancer and Unresectable Locally Metastatic Breast Cancer, run by Jiangsu HengRui Medicine Co., Ltd. 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 10 inclusion and 13 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 11 May 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?
Contact Xia Zhang (+86-0518-82342973, xia.zhang@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS). (time frame: Every 6 weeks after administration, approximately 14 months.). 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 11 May 2026.