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

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

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Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy
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RecruitingPhase 2
I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer
Breast Neoplasms, Breast Cancer

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