Early-stage or Locally Advanced HER2-positive Breast CancerPhase 3NCT07196774

A Trial of SHR-A1811 Compared to Other Antitumor Therapies as Neoadjuvant Treatments in Early-stage or Locally Advanced HER2-positive Breast Cancer

A Phase 3 study testing SHR-A1811 for Injection, Docetaxel injection and Trastuzumab Injection in people with Early-stage or Locally Advanced HER2-positive Breast Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 2 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years, women only
Conditions the study is for: Early-stage or Locally Advanced HER2-positive Breast Cancer
What is being tested?: SHR-A1811 for Injection, Docetaxel injection and Trastuzumab Injection
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 740 participants
Where: 2 sitesChina
Study dates: 23 Oct 2025to Dec 2028
Phase: Phase 3
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

Females treated for the first time, 18-75 years old;
ECOG score 0-1;
Has pathological diagnosis that meets the criteria: confirmed HER2 positive;
Results of laboratory tests meet the enrollment requirements;
Pregnancy test result must be negative and must agree to contraception;
Has signed the informed consent form.

Who cannot join

Confirmed HER2 negative;
Has tumor-related medical history or treatment history;
Has severe combined disease/medical history and treatment history;
Has received treatment with systemic immunostimulants or immunosuppressants;
Be allergic to the test drug;
Participate in other clinical trials simultaneously;

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Has received vaccine within 30 days before the first dose;
Has received allograft bone marrow transplantation;
Has given birth within one year or is breastfeeding;
Has history of psychological drug abuse, alcoholism or drug use.

Trial locations and contacts

2 sites in 1 country.

China2 sites

Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Shengjing Hospital, China Medical University
Shenyang, Liaoning, 110000

Other trials in China

About this study

Official title: A Randomized, Open-label, Multicenter Phase III Study of SHR-A1811 Compared to Docetaxel+Carboplatin+Trastuzumab+Pertuzumab as a Neoadjuvant Therapy for the Initial Treatment of Early-stage or Locally Advanced HER2-positive Breast Cancer

This study is a multicenter, randomized, open-label, parallel Phase III clinical trial. 650 early-stage or locally advanced breast cancer participants will be enrolled and randomly assigned to SHR-A1811 monotherapy group (trial group) or TCbHP treatment group (control group) at a 1:1 ratio. Participants will receive neoadjuvant treatments of SHR-A1811 or TCbHP, while those who have completed neoadjuvant therapy and are suitable for surgery must undergo surgical treatment. The participants will be evaluated on tumor efficacy through postoperative pathological assessment by IRC and pathologists from the research center. The primary endpoint will be tpCR evaluated by IRC. Participants who complete surgical treatment will be followed up for at least 3 years at study endpoints such as EFS, DFS, and DDFS.

Conditions: Early-stage or Locally Advanced HER2-positive Breast Cancer
Being tested: SHR-A1811 for Injection, Docetaxel injection, Trastuzumab Injection, Carboplatin for Injection, Pertuzumab Injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SHR-A1811 for InjectionDrug
SHR-A1811 for injection.
Docetaxel injectionDrug
Docetaxel injection.
Trastuzumab InjectionDrug
Trastuzumab injection.
Carboplatin for InjectionDrug
Carboplatin for injection.
Pertuzumab InjectionDrug
Pertuzumab injection.

Study groups in NCT07196774
Study group	Role	What they receive
SHR-A1811 Group	Experimental	Not described Receives: Drug: SHR-A1811 for Injection
Docetaxel+Carboplatin+Trastuzumab+Pertuzumab Group	Active comparator	Not described Receives: Drug: Docetaxel injection; Drug: Trastuzumab Injection; Drug: Carboplatin for Injection; Drug: Pertuzumab Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

Postoperative total pathologic complete response (tpCR) evaluated by Independent Review Committee (IRC) after finishing neoadjuvant treatments.
Measured: From the enrollment of the first subject to the end of the study, it lasted about 36 months.

Secondary outcomes (5)

Postoperative total pathologic complete response (tpCR) evaluated pathologists at the research center after finishing neoadjuvant treatments.
Measured: From the enrollment of the first subject to the end of the study, it lasted about 36 months.
Event-free survival (EFS).
Measured: Followed up for at least 3 years.
Disease-free survival (DFS).
Measured: Followed up for at least 3 years.
Distant disease-free survival (DDFS).
Measured: Followed up for at least 3 years.
Objective response rate (ORR) assessed according to the preoperative evaluation utilizing RECIST v1.1 after finishing neoadjuvant treatments.
Measured: Followed up for at least 3 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Oct 2025Dec 2028

First posted29 Sep 2025
Study start23 Oct 2025
Primary completionDec 2027 (estimated)
Study completionDec 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Early-stage or Locally Advanced HER2-positive Breast CancerStudies of the same condition, open and under way.
More trials run by Jiangsu HengRui Medicine Co., Ltd.The 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 740 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07196774
Sponsor's protocol ID: SHR-A1811-312
Status last verified: Jan 2026
First submitted: 22 Sep 2025
Last updated: 30 Jul 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
Phase II Neoadjuvant Pyrotinib Combined With Neoadjuvant Chemotherapy in HER2-low-expressing and HR Positive Early or Locally Advanced Breast Cancer: a Single-arm, Non-randomized, Single-center, Open Label Trial
Breast Cancer, HER2-low-expressing Breast Cancer
RecruitingPhase 3
Neoadjuvant Pyrotinib-to-pertuzumab in HER2+ eBC
Breast Cancer Early Stage Breast Cancer (Stage 1-3)
Not yet recruitingPhase 2
Culmerciclib Combined With Letrozole and Dual HER2 Blockade as Neoadjuvant Therapy for HR+/HER2+ Breast Cancer
Breast Cancer, HR Positive, HER2 Positive Breast Cancer
Active, not recruitingPhase 3
A Study of Evaluating The Effects Of Pyrotinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer
Breast Cancer
Active, not recruitingPhase 3
A Phase III Study of KN026 in Combination With HB1801 ± Carboplatin as Neoadjuvant Treatment for Early or Locally Advanced HER2-Positive Breast Cancer
Early or Locally Advanced HER2-positive Breast Cancer

All Early-stage or Locally Advanced HER2-positive Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-label, Multicenter Phase III Study of SHR-A1811 Compared to Docetaxel+Carboplatin+Trastuzumab+Pertuzumab as a Neoadjuvant Therapy for the Initial Treatment of Early-stage or Locally Advanced HER2-positive Breast Cancer
ClinicalTrials.gov ID: NCT07196774
Acronym / sponsor ID: SHR-A1811-312
Conditions: Early-stage or Locally Advanced HER2-positive Breast Cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 740 participants (actual)
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
Study start: 23 Oct 2025 (actual)
Primary completion: Dec 2027 (estimated)
Study completion: Dec 2028 (estimated)
First posted: 29 Sep 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
SHR-A1811 Group	Experimental	Drug: SHR-A1811 for Injection
Docetaxel+Carboplatin+Trastuzumab+Pertuzumab Group	Active comparator	Drug: Docetaxel injection, Drug: Trastuzumab Injection, Drug: Carboplatin for Injection, Drug: Pertuzumab Injection

Who may qualify

Ages: 18 to 75 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Females treated for the first time, 18-75 years old;
ECOG score 0-1;
Has pathological diagnosis that meets the criteria: confirmed HER2 positive;
Results of laboratory tests meet the enrollment requirements;
Pregnancy test result must be negative and must agree to contraception;

Key exclusion criteria (10 listed)

Confirmed HER2 negative;
Has tumor-related medical history or treatment history;
Has severe combined disease/medical history and treatment history;
Has received treatment with systemic immunostimulants or immunosuppressants;
Be allergic to the test drug;

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 InjectionSHR-A1811 for injection.	Drug	SHR-A1811 Group
Docetaxel injectionDocetaxel injection.	Drug	Docetaxel+Carboplatin+Trastuzumab+Pertuzumab Group
Trastuzumab InjectionTrastuzumab injection.	Drug	Docetaxel+Carboplatin+Trastuzumab+Pertuzumab Group
Carboplatin for InjectionCarboplatin for injection.	Drug	Docetaxel+Carboplatin+Trastuzumab+Pertuzumab Group
Pertuzumab InjectionPertuzumab injection.	Drug	Docetaxel+Carboplatin+Trastuzumab+Pertuzumab Group

Primary outcome

Postoperative total pathologic complete response (tpCR) evaluated by Independent Review Committee (IRC) after finishing neoadjuvant treatments.
Time frame: From the enrollment of the first subject to the end of the study, it lasted about 36 months.

5 secondary outcomes

Postoperative total pathologic complete response (tpCR) evaluated pathologists at the research center after finishing neoadjuvant treatments.
Time frame: From the enrollment of the first subject to the end of the study, it lasted about 36 months.
Event-free survival (EFS).
Time frame: Followed up for at least 3 years.
Disease-free survival (DFS).
Time frame: Followed up for at least 3 years.
Distant disease-free survival (DDFS).
Time frame: Followed up for at least 3 years.
Objective response rate (ORR) assessed according to the preoperative evaluation utilizing RECIST v1.1 after finishing neoadjuvant treatments.
Time frame: Followed up for at least 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 30 Jul 2026.
Individual participant dataSharing planned: Undecided

Related trials for Early-stage or Locally Advanced HER2-positive Breast Cancer

Active, not recruitingPhase 2
Phase II Neoadjuvant Pyrotinib Combined With Neoadjuvant Chemotherapy in HER2-low-expressing and HR Positive Early or Locally Advanced Breast Cancer: a Single-arm, Non-randomized, Single-center, Open Label Trial
Breast Cancer, HER2-low-expressing Breast Cancer
RecruitingPhase 3
Neoadjuvant Pyrotinib-to-pertuzumab in HER2+ eBC
Breast Cancer Early Stage Breast Cancer (Stage 1-3)
Not yet recruitingPhase 2
Culmerciclib Combined With Letrozole and Dual HER2 Blockade as Neoadjuvant Therapy for HR+/HER2+ Breast Cancer
Breast Cancer, HR Positive, HER2 Positive Breast Cancer
Active, not recruitingPhase 3
A Study of Evaluating The Effects Of Pyrotinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer
Breast Cancer
Active, not recruitingPhase 3
A Phase III Study of KN026 in Combination With HB1801 ± Carboplatin as Neoadjuvant Treatment for Early or Locally Advanced HER2-Positive Breast Cancer
Early or Locally Advanced HER2-positive Breast Cancer

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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 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: under way, not looking for participants, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Postoperative total pathologic complete response (tpCR) evaluated by Independent Review Committee (IRC) after finishing neoadjuvant treatments. (time frame: From the enrollment of the first subject to the end of the study, it lasted about 36 months.). 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 NCT07196774.

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 30 Jul 2026.