Metastatic Breast Cancer With HER2 PositivePhase 2NCT07132242
SHR-A1811 Combine With Pyrotinib for Locally Advanced/Metastatic HER2 Positive Breast Cancer
A Phase 2 study testing SHR-A1811 4.0mg/kg, Pyrotinib 240mg and SHR-A1811 4.8mg/kg in people with Metastatic Breast Cancer With HER2 Positive, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.
Trial summary
The goal of this clinical trial is to learn if SHR-A1811 combine with Pyrotinib is safe and tolerable for patients with HER2 positive breast cancer. It will also learn about the anti-tumor efficacy of this combination therapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Metastatic Breast Cancer With HER2 Positive
- What is being tested?
- SHR-A1811 4.0mg/kg, Pyrotinib 240mg and SHR-A1811 4.8mg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- 30 Aug 2025to 31 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: ≥18 years old and ≤70 years old;
- Pathologically confirmed HER2-positive locally advanced or metastatic breast cancer;
- Progression during or after prior HER2-targeted therapy and chemotherapy in the advanced/metastatic setting OR progression during/within 12 months after completion of trastuzumab and taxane-based chemotherapy in the neoadjuvant/adjuvant setting OR after 2 cycles of trastuzumab and taxane-based chemotherapy in the neoadjuvant setting with suboptimal response (assessed as non-response) for locally advanced disease;
- At least one measurable lesion per RECIST v1.1 criteria.
- ECOG performance status of 0 or 1.
- Adequate Organ Function
- Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose. Male subjects with partners of childbearing potential must be surgically sterile or agree to use effective contraception during the trial. Sperm donation is not permitted during the study period.
- Subjects must voluntarily enroll in this study, sign the informed consent form, demonstrate good compliance, and be willing to cooperate with follow-up.
Who cannot join
- Prior Pyrotinib in Advanced/Metastatic Setting;
- Prior Tropoisomerase I Inhibitor ADC Therapy;
- Active CNS Metastases;
- Other Malignancy;
- Recent Major Surgery/Trauma;
- Interstitial Lung Disease (ILD)/Severe Pulmonary Conditions;
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- Significant Cardiac Disease;
- Inability to swallow oral medication, chronic diarrhea, intestinal obstruction, or other factors significantly affecting drug ingestion or absorption;
- Known hypersensitivity to any component of the investigational drugs in this study protocol;
- Immunodeficiency/Organ Transplant;
- Uncontrolled Third-Space Fluid Accumulation;
- Pregnancy/Breastfeeding/Contraception;
- Severe concomitant illness or comorbid conditions that may interfere with planned treatment or preclude study participation, as assessed by the investigator. This includes, but is not limited to, active hepatitis B or pulmonary infection requiring treatment.
About this study
Official title: Safety and Efficacy of SHR-A1811 Combine With Pyrotinib for the Treatment of HER2 Positive Locally Advanced or Metastatic Breast Cancer, a Phase II Study
The goal of this clinical trial is to learn if SHR-A1811 combine with Pyrotinib is safe and tolerable for patients with HER2 positive breast cancer. It will also learn about the anti-tumor efficacy of this combination therapy. Participants will take SHR-A1811 and pyrotinib every three weeks, until disease progression or intolerable toxicity.
- Being tested
- SHR-A1811 4.0mg/kg, Pyrotinib 240mg, SHR-A1811 4.8mg/kg, Pyrotinib 320mg
- Keywords
- SHR-A1811, Pyrotinib, HER2 positive, metastatic breast cancer, locally advanced breast cancer, Antibody drug conjugates
- 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-A1811 4.0mg/kgDrug
SHR-A1811 4.0mg/kg, IV, Day 1, Q3W
Pyrotinib 240mgDrug
Pyrotinib 240mg, po, QD, from Day 8 to Day 21,Q3W
SHR-A1811 4.8mg/kgDrug
SHR-A1811 4.8mg/kg, IV, D1, Q3W
Pyrotinib 320mgDrug
Pyrotinib 320mg, po, QD, from Day 8 to Day 21, Q3W
| Study group | Role | What they receive |
|---|---|---|
| Arm 1：SHR-A1811 4.0mg/kg + Pyrotinib 240mg/Day | Experimental | Not described Receives: Drug: SHR-A1811 4.0mg/kg; Drug: Pyrotinib 240mg |
| Arm 2：SHR-A1811 4.0mg/kg + Pyrotinib 320mg/Day | Experimental | Not described Receives: Drug: SHR-A1811 4.0mg/kg; Drug: Pyrotinib 320mg |
| Arm 3: SHR-A1811 4.8mg/kg + Pyrotinib 240mg/Day | Experimental | Not described Receives: Drug: Pyrotinib 240mg; Drug: SHR-A1811 4.8mg/kg |
| Arm4: SHR-A1811 4.8mg/kg + Pyrotinib 320mg/Day | Experimental | Not described Receives: Drug: SHR-A1811 4.8mg/kg; Drug: Pyrotinib 320mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
the proportion of patients who experienced treatment-emergent adverse events during the study treatment among the total number of patients experienced study treatment.
Measured: From the date of signing ICF until the end of the safety follow-up period, defined as 40 days after the last administration of SHR-A1811 or Pyrotinib
ORR
Objective Response Rate: The proportion of subjects achieving a best overall response(per RECIST v1.1) of complete response (CR) or partial response (PR) during the period from initiation of the study treatment until disease progression (or treatment discontinuation), relative to the total number of subjects in the analysis set.
Measured: from initiation of the study treatment until disease progression (or treatment discontinuation), the observation period is up to 36 months.
Secondary outcomes (3)
PFS
progression free survival: the time interval from the date of ICF assigned until the first documented radiological disease progression (PD) or death from any cause. For subjects who had not experienced PD or death by the data cutoff date, or had received subsequent anti-cancer therapy, censoring will occur at the date of the last valid tumor assessment prior to the data cutoff date, or the initiation date of new anti-cancer therapy, whichever occurs first .
Measured: from the date of enrollment until the first documented radiological disease progression (PD) or death from any cause, the observation period is up to 36 months.
OS
over all survival: The time from the date of enrollment to the date of death due to any cause. For subjects alive at the last follow-up , OS will be censored at the date of last contact . For subjects lost to follow-up , OS will be censored at the last date the subject was verified alive .Censored OS is defined as the time from enrollment to the censoring date.
Measured: The time from the date of enrollment to the date of death due to any cause. The observation period is up to 60 months.
DoR
Duration of response:The time interval from the date of first documented response (complete response [CR] or partial response [PR], whichever is recorded earlier) until the date of disease progression or death of any cause.
Measured: from the date of first documented response to the date of disease progression or death of any cause, the observation period is up to 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start30 Aug 2025 (estimated)
- Primary completion30 Aug 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast Cancer With HER2 PositiveStudies 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
- 84 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Yunnan Cancer Hospital
- Responsible party
- Principal investigator, Ma Fei，MD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07132242
- Sponsor's protocol ID
- MA-BC-II-092
- Status last verified
- Aug 2025
- First submitted
- 1 Aug 2025
- Last updated
- 20 Aug 2025
- 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 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of SHR-A1811 Combine With Pyrotinib for the Treatment of HER2 Positive Locally Advanced or Metastatic Breast Cancer, a Phase II Study
- ClinicalTrials.gov ID
- NCT07132242
- Acronym / sponsor ID
- MA-BC-II-092
- Keywords
- SHR-A1811, Pyrotinib, HER2 positive, metastatic breast cancer, locally advanced breast cancer, Antibody drug conjugates
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Yunnan Cancer Hospital
- Study start
- 30 Aug 2025 (estimated)
- Primary completion
- 30 Aug 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 20 Aug 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 SHR-A1811 combine with Pyrotinib is safe and tolerable for patients with HER2 positive breast cancer. It will also learn about the anti-tumor efficacy of this combination therapy. Participants will take SHR-A1811 and pyrotinib 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
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1：SHR-A1811 4.0mg/kg + Pyrotinib 240mg/Day | Experimental | Drug: SHR-A1811 4.0mg/kg, Drug: Pyrotinib 240mg |
| Arm 2：SHR-A1811 4.0mg/kg + Pyrotinib 320mg/Day | Experimental | Drug: SHR-A1811 4.0mg/kg, Drug: Pyrotinib 320mg |
| Arm 3: SHR-A1811 4.8mg/kg + Pyrotinib 240mg/Day | Experimental | Drug: Pyrotinib 240mg, Drug: SHR-A1811 4.8mg/kg |
| Arm4: SHR-A1811 4.8mg/kg + Pyrotinib 320mg/Day | Experimental | Drug: SHR-A1811 4.8mg/kg, Drug: Pyrotinib 320mg |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age: ≥18 years old and ≤70 years old;
- Pathologically confirmed HER2-positive locally advanced or metastatic breast cancer;
- Progression during or after prior HER2-targeted therapy and chemotherapy in the advanced/metastatic setting OR progression during/within 12 months after completion of trastuzumab and taxane-based chemotherapy in the neoadjuvant/adjuvant setting OR after 2 cycles of trastuzumab and taxane-based chemotherapy in the neoadjuvant setting with suboptimal response (assessed as non-response) for locally advanced disease;
- At least one measurable lesion per RECIST v1.1 criteria.
- ECOG performance status of 0 or 1.
Key exclusion criteria (13 listed)
- Prior Pyrotinib in Advanced/Metastatic Setting;
- Prior Tropoisomerase I Inhibitor ADC Therapy;
- Active CNS Metastases;
- Other Malignancy;
- Recent Major Surgery/Trauma;
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-A1811 4.0mg/kgSHR-A1811 4.0mg/kg, IV, Day 1, Q3W | Drug | Arm 1：SHR-A1811 4.0mg/kg + Pyrotinib 240mg/Day, Arm 2：SHR-A1811 4.0mg/kg + Pyrotinib 320mg/Day |
| Pyrotinib 240mgPyrotinib 240mg, po, QD, from Day 8 to Day 21,Q3W | Drug | Arm 1：SHR-A1811 4.0mg/kg + Pyrotinib 240mg/Day, Arm 3: SHR-A1811 4.8mg/kg + Pyrotinib 240mg/Day |
| SHR-A1811 4.8mg/kgSHR-A1811 4.8mg/kg, IV, D1, Q3W | Drug | Arm 3: SHR-A1811 4.8mg/kg + Pyrotinib 240mg/Day, Arm4: SHR-A1811 4.8mg/kg + Pyrotinib 320mg/Day |
| Pyrotinib 320mgPyrotinib 320mg, po, QD, from Day 8 to Day 21, Q3W | Drug | Arm 2：SHR-A1811 4.0mg/kg + Pyrotinib 320mg/Day, Arm4: SHR-A1811 4.8mg/kg + Pyrotinib 320mg/Day |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: From the date of signing ICF until the end of the safety follow-up period, defined as 40 days after the last administration of SHR-A1811 or Pyrotinib
the proportion of patients who experienced treatment-emergent adverse events during the study treatment among the total number of patients experienced study treatment.
ORR
Time frame: from initiation of the study treatment until disease progression (or treatment discontinuation), the observation period is up to 36 months.
Objective Response Rate: The proportion of subjects achieving a best overall response(per RECIST v1.1) of complete response (CR) or partial response (PR) during the period from initiation of the study treatment until disease progression (or treatment discontinuation), relative to the total number of subjects in the analysis set.
3 secondary outcomes
PFS
Time frame: from the date of enrollment until the first documented radiological disease progression (PD) or death from any cause, the observation period is up to 36 months.
OS
Time frame: The time from the date of enrollment to the date of death due to any cause. The observation period is up to 60 months.
DoR
Time frame: from the date of first documented response to the date of disease progression or death of any cause, the observation period is up to 36 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 20 Aug 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHR-A1811 4.0mg/kg, Pyrotinib 240mg and SHR-A1811 4.8mg/kg in people with Metastatic Breast Cancer With HER2 Positive, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.
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 8 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 20 Aug 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: From the date of signing ICF until the end of the safety follow-up period, defined as 40 days after the last administration of SHR-A1811 or Pyrotinib). The study lists 2 primary outcomes in all. 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 20 Aug 2025.