HER2-PositiveRecurrent or Metastatic Breast CancerPhase 3NCT06057610
A Phase III Study of SHR-A1811 Injection With or Without Pertuzumab in HER2-Positive Recurrent or Metastatic Breast Cancer
A Phase 3 study testing SHR-A1811 Injection, SHR-A1811 Injection ； Pertuzumab Injection and Trastuzumab Injection；Pertuzumab Injection ； Docetaxel Injection in people with HER2-PositiveRecurrent or Metastatic Breast Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
To evaluate the efficacy and safety of SHR-A1811 with or without pertuzumab versus trastuzumab, pertuzumab and docetaxel in HER2-Positive Recurrent or Metastatic Breast Cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- HER2-PositiveRecurrent or Metastatic Breast Cancer
- What is being tested?
- SHR-A1811 Injection, SHR-A1811 Injection ； Pertuzumab Injection and Trastuzumab Injection；Pertuzumab Injection ； Docetaxel Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 868 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2023to Oct 2032
- 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
- Women aged 18 to 75 (inclusive)
- HER2 positive (IHC3+ or ISH+) unresectable or metastatic breast cancer confirmed by histology or cytology.
- ECOG score is 0 or 1
- An expected survival of ≥ 12 weeks
- At least one measurable lesion according to RECIST v1.1 criteria
- Have adequate renal and hepatic function
- Patients voluntarily joined the study and signed informed consent
Who cannot join
- Have other malignancies within the past 5 years
- Active central nervous system metastasis without surgery or radiotherapy
- In (neoadjuvant) adjuvant therapy phase, the interval from the end of systemic therapy (excluding endocrine therapy) to the detection of recurrence/metastasis ≤12 months
- Presence with uncontrollable third space effusion
- Have undergone other anti-tumor treatment within 4 weeks before the first dose
- A history of immune deficiency
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- Clinically significant cardiovascular disorders
- Known or suspected interstitial lung disease
- The toxicity from previous anti-tumor treatment has not recovered to ≤ grade I
- Known hereditary or acquired bleeding tendency
- Active hepatitis and liver cirrhosis
- Presence of other serious physical or mental diseases or laboratory abnormalities
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
About this study
Official title: A Phase III Multicenter, Randomized, Open-label, Active-Controlled Study of SHR-A1811 With or Without Pertuzumab Versus Trastuzumab, Pertuzumab and Docetaxel in HER2-Positive Recurrent or Metastatic Breast Cancer
To evaluate the efficacy and safety of SHR-A1811 with or without pertuzumab versus trastuzumab, pertuzumab and docetaxel in HER2-Positive Recurrent or Metastatic Breast Cancer
- Being tested
- SHR-A1811 Injection, SHR-A1811 Injection ； Pertuzumab Injection, Trastuzumab Injection；Pertuzumab Injection ； Docetaxel Injection
- 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 InjectionDrug
SHR-A1811 Injection
SHR-A1811 Injection ； Pertuzumab InjectionDrug
SHR-A1811 Injection ； Pertuzumab Injection
Trastuzumab Injection；Pertuzumab Injection ； Docetaxel InjectionDrug
Trastuzumab Injection；Pertuzumab Injection ； Docetaxel Injection
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A: SHR-A1811 Injection | Experimental | Not described Receives: Drug: SHR-A1811 Injection |
| Treatment group B: SHR-A1811 Injection and Pertuzumab Injection | Experimental | Not described Receives: Drug: SHR-A1811 Injection ； Pertuzumab Injection |
| Treatment group C: Trastuzumab Injection, Pertuzumab Injection and Docetaxel Injection | Active comparator | Not described Receives: Drug: Trastuzumab Injection；Pertuzumab Injection ； Docetaxel Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival by Blinded Independent Central Review
Measured: from first dose to disease progression, or death, whichever comes first, up to 3 years
Secondary outcomes (6)
Progression Free Survival by investigators
Measured: from first dose to disease progression, or death, whichever comes first, up to 3 years
Overall Survival
Measured: from first dose to death, up to 6 years
Objective Response Rate
Measured: from first dose to disease progression or death, whichever comes first, up to 3 years
Duration of response
Measured: from first dose to disease progression or death, whichever comes first, up to 3 years
AE
Measured: from Day1 to 40 or 90 days after last dose
Incidence and severity of serious adverse events (SAE)
Measured: from Day1 to 40 or 90 days after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start1 Nov 2023
- Primary completion15 Jul 2026
- Study completionOct 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-PositiveRecurrent or Metastatic 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
- 868 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06057610
- Sponsor's protocol ID
- SHR-A1811-307
- Status last verified
- Aug 2026
- First submitted
- 11 Sep 2023
- Last updated
- 9 Sep 2026
- Results posted
- No
- 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 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Multicenter, Randomized, Open-label, Active-Controlled Study of SHR-A1811 With or Without Pertuzumab Versus Trastuzumab, Pertuzumab and Docetaxel in HER2-Positive Recurrent or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT06057610
- Acronym / sponsor ID
- SHR-A1811-307
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 868 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 15 Jul 2026 (actual)
- Study completion
- Oct 2032 (estimated)
- First posted
- 28 Sep 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.
To evaluate the efficacy and safety of SHR-A1811 with or without pertuzumab versus trastuzumab, pertuzumab and docetaxel in HER2-Positive Recurrent or Metastatic Breast Cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment group A: SHR-A1811 Injection | Experimental | Drug: SHR-A1811 Injection |
| Treatment group B: SHR-A1811 Injection and Pertuzumab Injection | Experimental | Drug: SHR-A1811 Injection ； Pertuzumab Injection |
| Treatment group C: Trastuzumab Injection, Pertuzumab Injection and Docetaxel Injection | Active comparator | Drug: Trastuzumab Injection；Pertuzumab Injection ； Docetaxel Injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Women aged 18 to 75 (inclusive)
- HER2 positive (IHC3+ or ISH+) unresectable or metastatic breast cancer confirmed by histology or cytology.
- ECOG score is 0 or 1
- An expected survival of ≥ 12 weeks
- At least one measurable lesion according to RECIST v1.1 criteria
Key exclusion criteria (12 listed)
- Have other malignancies within the past 5 years
- Active central nervous system metastasis without surgery or radiotherapy
- In (neoadjuvant) adjuvant therapy phase, the interval from the end of systemic therapy (excluding endocrine therapy) to the detection of recurrence/metastasis ≤12 months
- Presence with uncontrollable third space effusion
- Have undergone other anti-tumor treatment within 4 weeks before the first dose
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 InjectionSHR-A1811 Injection | Drug | Treatment group A: SHR-A1811 Injection |
| SHR-A1811 Injection ； Pertuzumab InjectionSHR-A1811 Injection ； Pertuzumab Injection | Drug | Treatment group B: SHR-A1811 Injection and Pertuzumab Injection |
| Trastuzumab Injection；Pertuzumab Injection ； Docetaxel InjectionTrastuzumab Injection；Pertuzumab Injection ； Docetaxel Injection | Drug | Treatment group C: Trastuzumab Injection, Pertuzumab Injection and Docetaxel Injection |
Primary outcome
Progression Free Survival by Blinded Independent Central Review
Time frame: from first dose to disease progression, or death, whichever comes first, up to 3 years
6 secondary outcomes
Progression Free Survival by investigators
Time frame: from first dose to disease progression, or death, whichever comes first, up to 3 years
Overall Survival
Time frame: from first dose to death, up to 6 years
Objective Response Rate
Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years
Duration of response
Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years
AE
Time frame: from Day1 to 40 or 90 days after last dose
Incidence and severity of serious adverse events (SAE)
Time frame: from Day1 to 40 or 90 days after last dose
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 9 Sep 2026.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SHR-A1811 Injection, SHR-A1811 Injection ； Pertuzumab Injection and Trastuzumab Injection；Pertuzumab Injection ； Docetaxel Injection in people with HER2-PositiveRecurrent or Metastatic Breast Cancer, run by Jiangsu HengRui Medicine Co., Ltd. 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 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: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2026. 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 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?
Progression Free Survival by Blinded Independent Central Review (time frame: from first dose to disease progression, or death, whichever comes first, up to 3 years). 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 9 Sep 2026.