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.

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

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

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

Other trials in China

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

Conditions: HER2-PositiveRecurrent 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 groups in NCT06057610
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.

1 Nov 2023Oct 2032

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)

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