HER2-positive Breast CancerPhase 2NCT05635487
A Study of SHR-A1811 Monotherapy or Combined With Pyrotinib Maleate as Neoadjuvant Treatment in HER2-positive Breast Cancer Patients
A Phase 2 study testing SHR-A1811 and Pyrotinib in people with HER2-positive Breast Cancer, run by Shengjing Hospital at 1 site in China.
Trial summary
This is a phase II trial evaluating the efficacy and safety of SHR-A1811 monotherapy or combined with pyrotinib maleate in Stage II-III HER2-positive breast cancer. Subjects will receive the neoadjuvant therapy of SHR-A1811 monotherapy or combined with pyrotinib for six cycles, and then undergo surgery within 4 weeks… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- HER2-positive Breast Cancer
- What is being tested?
- SHR-A1811 and Pyrotinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteChina
- Study dates
- 16 Mar 2023to 28 Feb 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
- Female patients aged ≥ 18 but ≤ 75 years
- Histologically confirmed to be HER2-positive invasive breast cancer
- Treatment-naive patients with stage II-III
- Eastern Cooperative Oncology Group (ECOG) score 0-1
- Good level of organ function
Who cannot join
- Previously received any anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.)
- Received any other anti-tumor therapy at the same time
- Bilateral breast cancer, inflammatory breast cancer or occult breast cancer
- Stage IV breast cancer
- With a history of any malignancies in the past 5 years, excluding cured cervical carcinoma in situ and melanoma skin cancer
- Inability to swallow, chronic diarrhea, intestinal obstruction, and a variety of factors affecting drug administration and absorption
Show all 12Show fewer
- Participated in other drug clinical trials within 4 weeks before enrollment
- History of allergies to the drug components of this protocol
- Clinically significant pulmonary diseases
- Clinically significant cardiovascular diseases
- History of immunodeficiency
- Active hepatitis and liver cirrhosis
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
Shengjing Hospital affiliated to China Medical University
Shenyang, Liaoning, 110004
Nan Niu, MD
Cai-Gang Liu, MD
About this study
Official title: A Phase II Study of SHR-A1811 Monotherapy or Combined With Pyrotinib Maleate as Neoadjuvant Treatment in HER2-positive Breast Cancer Patients
This is a phase II trial evaluating the efficacy and safety of SHR-A1811 monotherapy or combined with pyrotinib maleate in Stage II-III HER2-positive breast cancer. Subjects will receive the neoadjuvant therapy of SHR-A1811 monotherapy or combined with pyrotinib for six cycles, and then undergo surgery within 4 weeks after neoadjuvant therapy. Efficacy will be assessed every 2 cycles.
- Conditions
- HER2-positive Breast Cancer
- Being tested
- SHR-A1811, Pyrotinib
- Keywords
- SHR-A1811, Pyrotinib, HER2-positive Breast Cancer, Neoadjuvant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-A1811Drug
SHR-A1811
PyrotinibDrug
Pyrotinib
| Study group | Role | What they receive |
|---|---|---|
| SHR-A1811+Pyrotinib | Experimental | Not described Receives: Drug: SHR-A1811; Drug: Pyrotinib |
| SHR-A1811 | Experimental | Not described Receives: Drug: SHR-A1811 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total pathological complete response (tpCR: ypT0-is/ypN0)
Measured: At the time of surgery
Secondary outcomes (8)
Breast pathological complete response (bpCR：ypT0-is)
Measured: At the time of surgery
Residual cancer burden (RCB)
Measured: At the time of surgery
Best overall response rate (BORR)
Measured: During 18 weeks of the neoadjuvant treatment
Overall survival (OS)
Measured: 5 years
Disease-free survival (DFS)
Measured: 5 years
Event-free survival (EFS)
Measured: 5 years
Health-related quality of life (HRQOL) (EORTC QLQ-C30)
The European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) Core 30 (EORTC QLQ-C30)
Measured: During 18 weeks of the neoadjuvant treatment
Health-related quality of life (HRQOL)
The European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire Breast Cancer (EORTC QLQ- BR23) will be used to measure the HRQOL.
Measured: During 18 weeks of the neoadjuvant treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start16 Mar 2023
- Primary completion28 Feb 2025 (estimated)
- Study completion28 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Breast CancerStudies of the same condition, open and under way.
- More trials run by Shengjing HospitalThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Responsible party
- Principal investigator, Caigang Liu, Shengjing Hospital
- Investigators
- Caigang Liu, MD, Principal investigator, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05635487
- Sponsor's protocol ID
- MUKDEN 07
- Status last verified
- Jul 2024
- First submitted
- 15 Nov 2022
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of SHR-A1811 Monotherapy or Combined With Pyrotinib Maleate as Neoadjuvant Treatment in HER2-positive Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT05635487
- Acronym / sponsor ID
- MUKDEN 07
- Conditions
- HER2-positive Breast Cancer
- Keywords
- SHR-A1811, Pyrotinib, HER2-positive Breast Cancer, Neoadjuvant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- 16 Mar 2023 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 28 Feb 2030 (estimated)
- First posted
- 2 Dec 2022 (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 phase II trial evaluating the efficacy and safety of SHR-A1811 monotherapy or combined with pyrotinib maleate in Stage II-III HER2-positive breast cancer. Subjects will receive the neoadjuvant therapy of SHR-A1811 monotherapy or combined with pyrotinib for six cycles, and then undergo surgery within 4 weeks after neoadjuvant therapy. Efficacy will be assessed every 2 cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SHR-A1811+Pyrotinib | Experimental | Drug: SHR-A1811, Drug: Pyrotinib |
| SHR-A1811 | Experimental | Drug: SHR-A1811 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female patients aged ≥ 18 but ≤ 75 years
- Histologically confirmed to be HER2-positive invasive breast cancer
- Treatment-naive patients with stage II-III
- Eastern Cooperative Oncology Group (ECOG) score 0-1
- Good level of organ function
Key exclusion criteria (12 listed)
- Previously received any anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.)
- Received any other anti-tumor therapy at the same time
- Bilateral breast cancer, inflammatory breast cancer or occult breast cancer
- Stage IV breast cancer
- With a history of any malignancies in the past 5 years, excluding cured cervical carcinoma in situ and melanoma skin cancer
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-A1811SHR-A1811 | Drug | SHR-A1811, SHR-A1811+Pyrotinib |
| PyrotinibPyrotinib | Drug | SHR-A1811+Pyrotinib |
Primary outcome
Total pathological complete response (tpCR: ypT0-is/ypN0)
Time frame: At the time of surgery
8 secondary outcomes
Breast pathological complete response (bpCR：ypT0-is)
Time frame: At the time of surgery
Residual cancer burden (RCB)
Time frame: At the time of surgery
Best overall response rate (BORR)
Time frame: During 18 weeks of the neoadjuvant treatment
Overall survival (OS)
Time frame: 5 years
Disease-free survival (DFS)
Time frame: 5 years
Event-free survival (EFS)
Time frame: 5 years
Health-related quality of life (HRQOL) (EORTC QLQ-C30)
Time frame: During 18 weeks of the neoadjuvant treatment
Health-related quality of life (HRQOL)
Time frame: During 18 weeks of the neoadjuvant treatment
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 Jul 2024.
- Individual participant dataSharing planned: No
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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.
Caigang Liu, MD principal investigator
Shengjing Hospital
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 SHR-A1811 and Pyrotinib in people with HER2-positive Breast Cancer, run by Shengjing Hospital 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 5 inclusion and 12 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 5 Jul 2024. 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 Nan Niu, MD (86-18940256668, niunannancy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total pathological complete response (tpCR: ypT0-is/ypN0) (time frame: At the time of surgery). 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 Jul 2024; AzTrials last refreshed its copy on 7 Nov 2026.