Advanced Breast CancerPhase 2NCT07630103
Efficacy and Safety of Trastuzumab Rezetecan or Trastuzumab Deruxtecan in Advanced Breast Cancer
A Phase 2 study testing Trastuzumab Rezetecan for Injection (SHR-A1811) and Trastuzumab Deruxtecan for Injection (T-DXd) in people with Advanced Breast Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Advanced Breast Cancer
- What is being tested?
- Trastuzumab Rezetecan for Injection (SHR-A1811) and Trastuzumab Deruxtecan for Injection (T-DXd)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jun 2026to Dec 2031
- 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 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.
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- 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 effective contraception methods from the signing of the informed consent form until 7 months after the last dose of the investigational product.
- Willing and able to provide written informed consent, with good compliance, and willing to cooperate with follow-up visits and study-related procedures.
Who cannot join
- Patients with known untreated spinal cord compression or active central nervous system (CNS) metastases, except for those who have been treated and have remained stable for at least 1 month and have discontinued corticosteroids for >2 weeks.
- History of other malignancies within the past 5 years, excluding cured basal cell carcinoma of the skin and carcinoma in situ of the cervix.
- Uncontrolled third-space fluid accumulation (e.g., massive ascites, pleural effusion, pericardial effusion) that cannot be managed by drainage or other methods.
- Having undergone major cancer-related surgery, radiotherapy, chemotherapy, immunotherapy, molecular targeted therapy, biotherapy, or other clinical investigational therapy within 4 weeks prior to the first dose.
- Prior treatment with an antibody-drug conjugate containing an exatecan derivative (a topoisomerase I inhibitor).
- Use of immunosuppressants or systemic corticosteroids for immunosuppressive purposes (at doses >10 mg/day prednisone or equivalent) within 2 weeks prior to the first dose, excluding topical, nasal spray, or inhaled corticosteroids.
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- Presence of any active autoimmune disease or a history of autoimmune disease that may potentially recur.
- History of immunodeficiency, including a positive HIV test, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.
- Patients with known or suspected interstitial lung disease (ILD); or presence of other moderate-to-severe pulmonary diseases that may significantly impair respiratory function or interfere with the detection or management of drug-related pulmonary toxicity within 3 months prior to the first dose, including but not limited to idiopathic pulmonary fibrosis, organizing pneumonia/bronchiolitis obliterans, pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease (COPD), obstructive/restrictive lung disease, etc.; and any autoimmune, connective tissue, or inflammatory disorders involving the lungs, such as rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.; or history of pneumonectomy. Patients who experienced ≥Grade 3 ILD during prior treatment with immune checkpoint inhibitors are excluded.
- Presence of active hepatitis B (HBsAg positive and HBV DNA ≥500 IU/mL), hepatitis C (anti-HCV positive and HCV RNA above the upper limit of normal), or liver cirrhosis; or severe infections requiring systemic antibiotic, antiviral, or antifungal therapy.
- Toxicities from prior anti-tumor therapy that have not recovered to ≤ Grade 1 (according to NCI-CTCAE v6.0).
- Known hypersensitivity to any of the study drugs or their excipients.
- Any other severe physical or mental illness or abnormal laboratory finding that, in the investigator's judgment, may increase the risk associated with study participation, interfere with the study results, or make 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
Sun Yat-Sen Memorial Hospital
Guangzhou, Guangdong
Jianli Zhao, MD, +86 15920589334, zhaojianli@163.com
About this study
Official title: A Comparison of the Efficacy and Safety of Trastuzumab Rezetecan(SHR-A1811) Versus Trastuzumab Deruxtecan(DS-8201) in Patients With HER2-Positive Metastatic Breast Cancer Previously Treated With Trastuzumab
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
- Conditions
- Advanced Breast Cancer
- Being tested
- Trastuzumab Rezetecan for Injection (SHR-A1811), Trastuzumab Deruxtecan for Injection (T-DXd)
- Keywords
- ADC, advanced breast cancer, T-DXd, SHR-A1811
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trastuzumab Rezetecan for Injection (SHR-A1811)Drug
Also called SHR-A1811, T-DXh, Trastuzumab rezetecan
SHR-A1811 4.8mg/kg iv q3w
Trastuzumab Deruxtecan for Injection (T-DXd)Drug
Also called DS-8201, T-DXd, Trastuzumab deruxtecan
T-DXd 5.4mg/kg iv q3w
| Study group | Role | What they receive |
|---|---|---|
| SHR-A1811 | Experimental | Not described Receives: Drug: Trastuzumab Rezetecan for Injection (SHR-A1811) |
| T-DXd | Active comparator | Not described Receives: Drug: Trastuzumab Deruxtecan for Injection (T-DXd) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival(PFS)
Time from the date of randomization until the date of first documented radiological disease progression (PD) or death from any cause, whichever occurs first. If a subject did not experience PD or death by the data cutoff date, or had received other anti-tumor therapy, censoring occurred at the date of the last efficacy assessment prior to the cutoff date or the start date of other anti-tumor therapy, whichever was earlier.
Measured: 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
Secondary outcomes (5)
Objective response rate (ORR)
The percentage of subjects in the analysis set whose best overall response (BOR) was a complete response (CR) or partial response (PR) from the start of the study treatment until the subject discontinued the study due to disease progression. It is recommended to use the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) to evaluate the objective tumor response. Subjects must have measurable tumor lesions at baseline, and the assessment of efficacy is recommended to be categorized according to RECIST 1.1 criteria into complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD).
Measured: From screening and every 6 weeks up to withdrawal of subject consent, progressive disease (PD), or unacceptable toxicity, up to approximately 3 years
Disease control rate(DCR)
The percentage of subjects in the analysis set whose best overall response (BOR) was complete response (CR), partial response (PR), or stable disease (SD) from the start of the study treatment regimen until the subject discontinued the study due to disease progression. It is recommended to use the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) to assess the objective tumor response. Subjects must have measurable tumor lesions at baseline, and the efficacy assessment is recommended to be categorized according to RECIST 1.1 criteria as complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD).
Measured: From screening and every 6 weeks up to withdrawal of subject consent, progressive disease (PD), or unacceptable toxicity, up to approximately 3 years
Duration of Response(DOR)
defined as the time from the date of first documented response (complete response, CR, or partial response, PR, whichever occurs first) to the date of disease progression or death, whichever occurs earlier. Response is assessed using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
Measured: From the date of the first documented objective response (CR or PR) to the first documented disease progression or death, whichever occurs first, up to approximately 3 years
Overall survival (OS)
Defined as the time from the date of enrollment to the date of death from any cause. For subjects who were alive at the last follow-up, their OS data are censored at the date of the last follow-up. For subjects who were lost to follow-up, their OS data are censored at the date of the last documented evidence of survival prior to being lost. Censored OS is defined as the time from enrollment to censoring.
Measured: From the date of randomization up to the date of death due to any cause, up to approximately 3 years
Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events(TESAEs)
Measured: From first dose of study drug (Day 1) up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionJun 2031 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Breast CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe 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
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07630103
- Sponsor's protocol ID
- MA-BC-II-137
- Status last verified
- May 2026
- First submitted
- 1 Jun 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- 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 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Efficacy and Safety of Trastuzumab Rezetecan(SHR-A1811) Versus Trastuzumab Deruxtecan(DS-8201) in Patients With HER2-Positive Metastatic Breast Cancer Previously Treated With Trastuzumab
- ClinicalTrials.gov ID
- NCT07630103
- Acronym / sponsor ID
- MA-BC-II-137
- Conditions
- Advanced Breast Cancer
- Keywords
- ADC, advanced breast cancer, T-DXd, SHR-A1811
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2031 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 5 Jun 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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SHR-A1811 | Experimental | Drug: Trastuzumab Rezetecan for Injection (SHR-A1811) |
| T-DXd | Active comparator | Drug: Trastuzumab Deruxtecan for Injection (T-DXd) |
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 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.
Key exclusion criteria (13 listed)
- Patients with known untreated spinal cord compression or active central nervous system (CNS) metastases, except for those who have been treated and have remained stable for at least 1 month and have discontinued corticosteroids for >2 weeks.
- History of other malignancies within the past 5 years, excluding cured basal cell carcinoma of the skin and carcinoma in situ of the cervix.
- Uncontrolled third-space fluid accumulation (e.g., massive ascites, pleural effusion, pericardial effusion) that cannot be managed by drainage or other methods.
- Having undergone major cancer-related surgery, radiotherapy, chemotherapy, immunotherapy, molecular targeted therapy, biotherapy, or other clinical investigational therapy within 4 weeks prior to the first dose.
- Prior treatment with an antibody-drug conjugate containing an exatecan derivative (a topoisomerase I inhibitor).
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 Injection (SHR-A1811)Also: SHR-A1811, T-DXh, Trastuzumab rezetecanSHR-A1811 4.8mg/kg iv q3w | Drug | SHR-A1811 |
| Trastuzumab Deruxtecan for Injection (T-DXd)Also: DS-8201, T-DXd, Trastuzumab deruxtecanT-DXd 5.4mg/kg iv q3w | Drug | T-DXd |
Primary outcome
Progression Free Survival(PFS)
Time frame: 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
Time from the date of randomization until the date of first documented radiological disease progression (PD) or death from any cause, whichever occurs first. If a subject did not experience PD or death by the data cutoff date, or had received other anti-tumor therapy, censoring occurred at the date of the last efficacy assessment prior to the cutoff date or the start date of other anti-tumor therapy, whichever was earlier.
5 secondary outcomes
Objective response rate (ORR)
Time frame: From screening and every 6 weeks up to withdrawal of subject consent, progressive disease (PD), or unacceptable toxicity, up to approximately 3 years
Disease control rate(DCR)
Time frame: From screening and every 6 weeks up to withdrawal of subject consent, progressive disease (PD), or unacceptable toxicity, up to approximately 3 years
Duration of Response(DOR)
Time frame: From the date of the first documented objective response (CR or PR) to the first documented disease progression or death, whichever occurs first, up to approximately 3 years
Overall survival (OS)
Time frame: From the date of randomization up to the date of death due to any cause, up to approximately 3 years
Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events(TESAEs)
Time frame: From first dose of study drug (Day 1) up to approximately 3 years
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 5 Jun 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 (SHR-A1811) and Trastuzumab Deruxtecan for Injection (T-DXd) in people with Advanced Breast Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University 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: opening soon, as of the sponsor's last update on 5 Jun 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 Erwei Song, PhD, MD (+86-13926477694, songew@mail.sysu.edu.cn), 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: 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). 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 5 Jun 2026.