Breast CancerPhase 2NCT07417241
SHR-A1811 vs Pyrotinib/Capecitabine in Trastuzumab-Resistant HER2+ Advanced Breast Cancer: A Randomized Study
A Phase 2 study testing SHR-A1811, Pyrotinib and Capecitabine in people with Breast Cancer and HER2-positive Breast Cancer, run by Peking University Cancer Hospital & Institute.
Trial summary
This is a prospective, multicenter, open-label, randomized, controlled Study. The purpose of this study is to evaluate the efficacy and safety of SHR-A1811 versus pyrotinib plus capecitabine in the treatment of trastuzumab primary-resistant HER2-positive advanced breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, HER2-positive Breast Cancer
- What is being tested?
- SHR-A1811, Pyrotinib and Capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 31 Mar 2026to 31 Dec 2029
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Histologically or cytologically confirmed HER2-positive advanced breast cancer (IHC 3+, or IHC 2+ with ISH amplification).
- ECOG performance status 0-2.
- Estimated life expectancy >12 weeks.
- At least one measurable lesion per RECIST v1.1 criteria;
- Patients with trastuzumab primary resistance is defined as follows:
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- Progression during or within 12 months after treatment in neoadjuvant or adjuvant setting (at least 9 weeks of trastuzumab treatment);
- For patients with de novo stage IV disease, progression during or within 3 months after treatment for locally advanced or metastatic disease in the first-line setting (at least 6 weeks of trastuzumab treatment).
- Adequate organ function as defined by the following laboratory criteria:
- Hematologic: absolute neutrophil count (ANC) ≥1.5 × 10⁹/L, platelet count (PLT) ≥100 × 10⁹/L, hemoglobin (HGB) ≥90 g/L.
- Hepatic: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × upper limit of normal (ULN) (≤5 × ULN in patients with liver metastases); total serum bilirubin (TBIL) ≤1.5 × ULN; serum albumin ≥30 g/L.
- Renal: serum creatinine (Cr) ≤1.5 × ULN or calculated creatinine clearance ≥50 mL/min using the Cockcroft-Gault formula.
- Coagulation: prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤1.5 × ULN.
- Cardiac: left ventricular ejection fraction (LVEF) ≥50%.
- Women of childbearing potential must have a negative pregnancy test at screening, and subjects of reproductive potential must agree to use effective contraception from study start until 6 months after the last dose of study treatment..
- Voluntary participation with written informed consent obtained prior to any study-related procedures.
Who cannot join
- Prior or current exposure to antibody-drug conjugates (ADCs) containing a topoisomerase I inhibitor, including but not limited to fam-trastuzumab deruxtecan (DS-8201a).
- Active brain metastases or leptomeningeal metastases (patients with asymptomatic/inactive brain metastases are allowed to be enrolled);
- Other malignancy diagnosed within 5 years prior to enrollment, excluding cured non-melanoma skin cancer, cervical carcinoma in situ, ductal carcinoma in situ, or stage I grade 1 endometrial cancer;
- Radiotherapy, any anti-HER2 targeted therapy, or chemotherapy within 4 weeks prior to enrollment; endocrine therapy within 2 weeks prior to enrollment;
- Positive for human immunodeficiency virus (HIV);
- Known hypersensitivity to any study drug or its excipients, or to humanized monoclonal antibody products (e.g., trastuzumab, pertuzumab, etc.);
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- Clinically significant cardiovascular disease, such as severe/unstable angina, symptomatic congestive heart failure (NYHA Class ≥II), clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention, myocardial infarction within 6 months prior to first dose, or cerebrovascular accident (including transient ischemic attack).
- Participants known or suspected to interstitial lung disease.
- Concurrent participation in any other interventional drug clinical trial.
- Refusal to comply with protocol-mandated follow-up. Presence of any additional severe physical or psychiatric disorder, or any laboratory abnormality that, in the investigator's judgment, could increase the subject's risk, confound study results, or render the patient unsuitable for enrollment.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy and Safety of SHR-A1811 Versus Pyrotinib Plus Capecitabine in Patients With Trastuzumab Primary-Resistant HER2-Positive Advanced Breast Cancer：A Prospective, Multicenter, Open-Label, Randomized, Controlled Study
This is a prospective, multicenter, open-label, randomized, controlled Study. The purpose of this study is to evaluate the efficacy and safety of SHR-A1811 versus pyrotinib plus capecitabine in the treatment of trastuzumab primary-resistant HER2-positive advanced breast cancer.
- Conditions
- Breast Cancer, HER2-positive Breast Cancer
- Being tested
- SHR-A1811, Pyrotinib, Capecitabine, T-DXd
- Keywords
- HER2-positive breast cancer, SHR-A1811
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-A1811Drug
4.8 mg/kg administered as an intravenous infusion on Day 1 of each cycle. 3 weeks a cycle. Continuous medication until study completion, occurrence of intolerable toxicity, disease progression, withdrawal from the study for any reason, or death, whichever occurs first, or until the investigator deems that the patient would no longer benefit from the treatment.
PyrotinibDrug
400 mg, administered orally once daily, continuous medication until study completion, occurrence of intolerable toxicity, disease progression, withdrawal from the study for any reason, or death, whichever occurs first, or until the investigator deems that the patient would no longer benefit from the treatment.
CapecitabineDrug
1000mg/m2, administered orally twice daily on Days 1-14, with no administration on Days 15-21, 3 weeks a cycle. Continuous medication until study completion, occurrence of intolerable toxicity, disease progression, withdrawal from the study for any reason, or death, whichever occurs first, or until the investigator deems that the patient would no longer benefit from the treatment.
T-DXdDrug
5.4 mg/kg administered as an intravenous infusion on Day 1 of each cycle. 3 weeks a cycle. Continuous medication until study completion, occurrence of intolerable toxicity, disease progression, withdrawal from the study for any reason, or death, whichever occurs first, or until the investigator deems that the patient would no longer benefit from the treatment.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Treatment Phase 1: SHR-A1811 monotherapy until progression or intolerable adverse events.
Treatment Phase 2: Switch to pyrotinib plus capecitabine upon progression from Phase 1, continued until subsequent progression or intolerable adverse events. Receives: Drug: SHR-A1811; Drug: Pyrotinib; Drug: Capecitabine |
| Arm 2 | Active comparator | Treatment Phase 1: Pyrotinib plus capecitabineuntil progression or intolerable adverse events.
Treatment Phase 2: Switch to T-DXd upon progression from Phase 1, continued until subsequent progression or intolerable adverse events. Receives: Drug: Pyrotinib; Drug: Capecitabine; Drug: T-DXd |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS during treatment phase 1
progression free survival during treatment phase 1 : time from randomization to the first observation of tumor progression or death from any cause during treatment phase 1.
Measured: Start of treatment until 2-year follow-up
Secondary outcomes (9)
Total PFS across treatment phase 1 and treatment phase 2
Total progression free survival across treatment phase 1 and treatment phase 2: time from randomization to the second observation of tumor progression or death from any cause across treatment phase 1 and treatment phase 2.
Measured: Start of treatment until 3-year follow-up
PFS during treatment phase 2
progression free survival during treatment phase 2 : time from the first observation of tumor progression to the second observation of tumor progression or death from any cause during treatment phase 2.
Measured: Start of treatment until 3-year follow-up
ORR during treatment phase 1
Objective response rate during treatment phase 1: proportion of subjects who achieved complete response (CR) or partial response (PR) by primary tumor imaging evaluation during treatment phase 1.
Measured: Start of treatment until 2-year follow-up
DCR during treatment phase 1
Disease control rate during treatment phase 1: proportion of subjects who achieved complete response (CR) or partial response (PR) or stable disease (SD) by primary tumor imaging evaluation during treatment phase 1.
Measured: Start of treatment until 2-year follow-up
OS
Overall survival: time from randomization to death from any cause.
Measured: Start of treatment until 3-year follow-up
Incidence of adverse events
Measured: Start of treatment until 3-year follow-up
Severity of adverse events
Measured: Start of treatment until 3-year follow-up
Incidence of serious adverse events
Measured: Start of treatment until 3-year follow-up
Severity of serious adverse events
Measured: Start of treatment until 3-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start31 Mar 2026 (estimated)
- Primary completion31 Jan 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe 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
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanfang Jiang, MD, Peking University Cancer Hospital & Institute
- Investigators
- Hanfang Jiang, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07417241
- Sponsor's protocol ID
- OBU-BC-II-300
- Status last verified
- Feb 2026
- First submitted
- 11 Feb 2026
- Last updated
- 18 Feb 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 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of SHR-A1811 Versus Pyrotinib Plus Capecitabine in Patients With Trastuzumab Primary-Resistant HER2-Positive Advanced Breast Cancer：A Prospective, Multicenter, Open-Label, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT07417241
- Acronym / sponsor ID
- OBU-BC-II-300
- Conditions
- Breast Cancer, HER2-positive Breast Cancer
- Keywords
- HER2-positive breast cancer, SHR-A1811
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 31 Mar 2026 (estimated)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 18 Feb 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 is a prospective, multicenter, open-label, randomized, controlled Study. The purpose of this study is to evaluate the efficacy and safety of SHR-A1811 versus pyrotinib plus capecitabine in the treatment of trastuzumab primary-resistant HER2-positive advanced breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: SHR-A1811, Drug: Pyrotinib, Drug: CapecitabineTreatment Phase 1: SHR-A1811 monotherapy until progression or intolerable adverse events. Treatment Phase 2: Switch to pyrotinib plus capecitabine upon progression from Phase 1, continued until subsequent progression or intolerable adverse events. |
| Arm 2 | Active comparator | Drug: Pyrotinib, Drug: Capecitabine, Drug: T-DXdTreatment Phase 1: Pyrotinib plus capecitabineuntil progression or intolerable adverse events. Treatment Phase 2: Switch to T-DXd upon progression from Phase 1, continued until subsequent progression or intolerable adverse events. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age ≥18 years.
- Histologically or cytologically confirmed HER2-positive advanced breast cancer (IHC 3+, or IHC 2+ with ISH amplification).
- ECOG performance status 0-2.
- Estimated life expectancy >12 weeks.
- At least one measurable lesion per RECIST v1.1 criteria;
Key exclusion criteria (10 listed)
- Prior or current exposure to antibody-drug conjugates (ADCs) containing a topoisomerase I inhibitor, including but not limited to fam-trastuzumab deruxtecan (DS-8201a).
- Active brain metastases or leptomeningeal metastases (patients with asymptomatic/inactive brain metastases are allowed to be enrolled);
- Other malignancy diagnosed within 5 years prior to enrollment, excluding cured non-melanoma skin cancer, cervical carcinoma in situ, ductal carcinoma in situ, or stage I grade 1 endometrial cancer;
- Radiotherapy, any anti-HER2 targeted therapy, or chemotherapy within 4 weeks prior to enrollment; endocrine therapy within 2 weeks prior to enrollment;
- Positive for human immunodeficiency virus (HIV);
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 |
|---|---|---|
| SHR-A18114.8 mg/kg administered as an intravenous infusion on Day 1 of each cycle. 3 weeks a cycle. Continuous medication until study completion, occurrence of intolerable toxicity, disease progression, withdrawal from the study for any reason, or death, whichever occurs first, or until the investigator deems that the patient would no longer benefit from the treatment. | Drug | Arm 1 |
| Pyrotinib400 mg, administered orally once daily, continuous medication until study completion, occurrence of intolerable toxicity, disease progression, withdrawal from the study for any reason, or death, whichever occurs first, or until the investigator deems that the patient would no longer benefit from the treatment. | Drug | Arm 1, Arm 2 |
| Capecitabine1000mg/m2, administered orally twice daily on Days 1-14, with no administration on Days 15-21, 3 weeks a cycle. Continuous medication until study completion, occurrence of intolerable toxicity, disease progression, withdrawal from the study for any reason, or death, whichever occurs first, or until the investigator deems that the patient would no longer benefit from the treatment. | Drug | Arm 1, Arm 2 |
| T-DXd5.4 mg/kg administered as an intravenous infusion on Day 1 of each cycle. 3 weeks a cycle. Continuous medication until study completion, occurrence of intolerable toxicity, disease progression, withdrawal from the study for any reason, or death, whichever occurs first, or until the investigator deems that the patient would no longer benefit from the treatment. | Drug | Arm 2 |
Primary outcome
PFS during treatment phase 1
Time frame: Start of treatment until 2-year follow-up
progression free survival during treatment phase 1 : time from randomization to the first observation of tumor progression or death from any cause during treatment phase 1.
9 secondary outcomes
Total PFS across treatment phase 1 and treatment phase 2
Time frame: Start of treatment until 3-year follow-up
PFS during treatment phase 2
Time frame: Start of treatment until 3-year follow-up
ORR during treatment phase 1
Time frame: Start of treatment until 2-year follow-up
DCR during treatment phase 1
Time frame: Start of treatment until 2-year follow-up
OS
Time frame: Start of treatment until 3-year follow-up
Incidence of adverse events
Time frame: Start of treatment until 3-year follow-up
Severity of adverse events
Time frame: Start of treatment until 3-year follow-up
Incidence of serious adverse events
Time frame: Start of treatment until 3-year follow-up
Severity of serious adverse events
Time frame: Start of treatment until 3-year follow-up
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 18 Feb 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.
Hanfang Jiang principal investigator
Peking University Cancer Hospital & Institute
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHR-A1811, Pyrotinib and Capecitabine in people with Breast Cancer and HER2-positive Breast Cancer, run by Peking University Cancer Hospital & Institute.
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 16 inclusion and 10 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 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Hanfang Jiang (+86-010-88196380, hfjiangcn@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS during treatment phase 1 (time frame: Start of treatment until 2-year follow-up). 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 18 Feb 2026.