HER2 Low Breast CarcinomaPhase 2NCT05911958
A Study of SHR-A1811 as Neoadjuvant Treatment for Patients With HR-Positive, Low HER2 Expression Breast Cancer
A Phase 2 study testing SHR-A1811 for injection in people with HER2 Low Breast Carcinoma, run by Henan Cancer Hospital at 1 site in China.
Trial summary
HR-positive breast cancers accounts for about 50% to 60% of all breast cancer patients. Neoadjuvant Chemotherapy is the core treatment mode for this type of breast cancer, and endocrine therapy can be used in some low-risk patients. However, the pathological complete response (pCR) rate obtained is low. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- HER2 Low Breast Carcinoma
- What is being tested?
- SHR-A1811 for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 5 Jul 2023to 31 May 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 to 70 years old (inclusive);
- Treatment-naive patients with clinically confirmed T2-T3, any nodal status and M0;
- HR-positive, HER2 low expression, the expression of Ki-67 exceed 14% invasive breast cancer confirmed by histology or cytology;
- ECOG performance status of 0-1;
- Normal organ and bone marrow function;
- Patients of childbearing age must consent to use highly effective contraception for 7 months from the start of study screening until the last study medication and agree not to breastfeeding;
- Patients voluntarily joined the study and signed informed consent;
Who cannot join
- Patients have evidence of metastatic breast cancer, or inflammatory breast cancer;
- Patients previously received antineoplastic therapy or radiotherapy for any malignancy, excluding cured malignancies such as cervical carcinoma in situ, basal cell carcinoma, or squamous carcinoma;
- Patients received any other anti-tumor therapy at the same time, including endocrine therapy, bisphosphonates or immunotherapy;
- Patients have major surgical procedures unrelated to breast cancer within 4 weeks before the first medication, or not fully recovered from surgical procedures;
- Clinically significant pulmonary or cardiovascular disease;
- Failure to swallow, chronic diarrhea, intestinal obstruction, or presence of other factors affecting drug administration and absorption;
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- Known to be allergic to any study drug or any of its excipients;
- History of immunodeficiency, including HIV-positive, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation;
- Pregnant and lactating women;
- Patients with serious concomitant diseases or other comorbidities that will interfere with the planned treatment, or any other condition that is not suitable for participation assessed by investigator.
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
Henan Cancer Hospital
Zhengzhou, Henan, 450008
Jiao DeChuang, 13598004327, jiaodechuang1982@163.com
About this study
Official title: Phase II Study of SHR-A1811 as Neoadjuvant Treatment for Patients With HR-Positive, Low HER2 Expression Breast Cancer
HR-positive breast cancers accounts for about 50% to 60% of all breast cancer patients. Neoadjuvant Chemotherapy is the core treatment mode for this type of breast cancer, and endocrine therapy can be used in some low-risk patients. However, the pathological complete response (pCR) rate obtained is low. HER2 is an important prognostic indicator and therapeutic target for breast cancer. Nearly 60% of HR-positive breast cancers have low expression of HER2, and antibody-drug conjugates (ADC) targeting HER2 may achieve better efficacy in this subtype.
Read the detailed description
This prospective, single-arm study is being conducted to evaluate the efficacy and safety of SHR-A1811 for early-stage or locally advanced breast cancer patients with HR-Positive, Low HER2 Expression. Subjects will receive the neoadjuvant therapy of SHR-A1811 for eight cycles, and then undergo surgery within 4 weeks after neoadjuvant therapy. The follow-up visit will last for at least 5 years.
- Conditions
- HER2 Low Breast Carcinoma
- Being tested
- SHR-A1811 for injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-A1811 for injectionDrug
Also called SHR-A1811 group
SHR-A1811 for injection
| Study group | Role | What they receive |
|---|---|---|
| SHR-A1811 | Experimental | SHR-A1811 group Receives: Drug: SHR-A1811 for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) Tumours (RECIST) v1.1
Objective Response Rate (ORR) according to Response Evaluation Criteria in Solid
Measured: During 24 weeks of the neoadjuvant treatment
Secondary outcomes (5)
Incidence of Adverse Events
Evaluate the nature, incidence and severity of SHR-A1811 adverse events according to CTCAE 5.0
Measured: from consent to 28 days after last dose
Residual cancer burden (RCB)
Residual cancer burden (RCB)
Measured: At the time of surgery
Pathological complete response
pCR: ypT0/is ypN0
Measured: At the time of surgery
Event-free survival (EFS)
EFS was defined as the time from randomization to any of the following events: disease progression during neoadjuvant therapy, local or distant recurrence, second primary malignancy (breast or other cancer), or death from any cause
Measured: 5 years
Disease-free survival (DFS)
Disease-free Survival, From the date of surgery to the first local, regional, contralateral or distant recurrence, and death from any cause
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start5 Jul 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HER2 Low Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by Henan Cancer 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zhenzhen Liu, Henan Cancer Hospital
- Investigators
- Zhenzhen Liu, PhD, Principal investigator, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05911958
- Sponsor's protocol ID
- HELEN-015
- Other IDs
- BC-NEO-IIT-SHR-A1811
- Status last verified
- Oct 2024
- First submitted
- 12 Jun 2023
- Last updated
- 4 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jiao D, Zhu J, Sun X, Lu Z, Qiao J, Chen X, Wang C, Yan M, Zhang C, Li L, Wang J, Jin M, Wu Y, Liu Z. Neoadjuvant anti-HER2 antibody-drug conjugate SHR-A1811 in Hormone Receptor-positive, HER2-low Breast Cancer: A Phase 2 Clinical Trial (HELEN-015). Nat Commun. 2026 Aug 31;17(1):10339. doi: 10.1038/s41467-026-77041-x.
PubMed 42811016
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of SHR-A1811 as Neoadjuvant Treatment for Patients With HR-Positive, Low HER2 Expression Breast Cancer
- ClinicalTrials.gov ID
- NCT05911958
- Acronym / sponsor ID
- HELEN-015
- Conditions
- HER2 Low Breast Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 5 Jul 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 22 Jun 2023 (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.
HR-positive breast cancers accounts for about 50% to 60% of all breast cancer patients. Neoadjuvant Chemotherapy is the core treatment mode for this type of breast cancer, and endocrine therapy can be used in some low-risk patients. However, the pathological complete response (pCR) rate obtained is low. HER2 is an important prognostic indicator and therapeutic target for breast cancer. Nearly 60% of HR-positive breast cancers have low expression of HER2, and antibody-drug conjugates (ADC) targeting HER2 may achieve better efficacy in this subtype.
Detailed description
This prospective, single-arm study is being conducted to evaluate the efficacy and safety of SHR-A1811 for early-stage or locally advanced breast cancer patients with HR-Positive, Low HER2 Expression. Subjects will receive the neoadjuvant therapy of SHR-A1811 for eight cycles, and then undergo surgery within 4 weeks after neoadjuvant therapy. The follow-up visit will last for at least 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHR-A1811 | Experimental | Drug: SHR-A1811 for injectionSHR-A1811 group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients aged 18 to 70 years old (inclusive);
- Treatment-naive patients with clinically confirmed T2-T3, any nodal status and M0;
- HR-positive, HER2 low expression, the expression of Ki-67 exceed 14% invasive breast cancer confirmed by histology or cytology;
- ECOG performance status of 0-1;
- Normal organ and bone marrow function;
Key exclusion criteria (10 listed)
- Patients have evidence of metastatic breast cancer, or inflammatory breast cancer;
- Patients previously received antineoplastic therapy or radiotherapy for any malignancy, excluding cured malignancies such as cervical carcinoma in situ, basal cell carcinoma, or squamous carcinoma;
- Patients received any other anti-tumor therapy at the same time, including endocrine therapy, bisphosphonates or immunotherapy;
- Patients have major surgical procedures unrelated to breast cancer within 4 weeks before the first medication, or not fully recovered from surgical procedures;
- Clinically significant pulmonary or cardiovascular disease;
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 for injectionAlso: SHR-A1811 groupSHR-A1811 for injection | Drug | SHR-A1811 |
Primary outcome
Objective Response Rate (ORR) Tumours (RECIST) v1.1
Time frame: During 24 weeks of the neoadjuvant treatment
Objective Response Rate (ORR) according to Response Evaluation Criteria in Solid
5 secondary outcomes
Incidence of Adverse Events
Time frame: from consent to 28 days after last dose
Residual cancer burden (RCB)
Time frame: At the time of surgery
Pathological complete response
Time frame: At the time of surgery
Event-free survival (EFS)
Time frame: 5 years
Disease-free survival (DFS)
Time frame: 5 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 4 Nov 2024.
- Derived from this study: PubMed 42811016Jiao D, Zhu J, Sun X, Lu Z, Qiao J, Chen X, Wang C, Yan M, Zhang C, Li L, Wang J, Jin M, Wu Y, Liu Z. Neoadjuvant anti-HER2 antibody-drug conjugate SHR-A1811 in Hormone Receptor-positive, HER2-low Breast Cancer: A Phase 2 Clinical Trial (HELEN-015). Nat Commun. 2026 Aug 31;17(1):10339. doi: 10.1038/s41467-026-77041-x.
- 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.
Zhenzhen Liu, PhD principal investigator
Henan Cancer 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 for injection in people with HER2 Low Breast Carcinoma, run by Henan Cancer 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 7 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: looking for participants now, as of the sponsor's last update on 4 Nov 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 Zhenzhen Liu, Professor (+86-13603862755, liuzhenzhen73@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) Tumours (RECIST) v1.1 (time frame: During 24 weeks of the neoadjuvant treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05911958, which also lists 1 linked publication.
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 4 Nov 2024.