HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and TaxanePhase 3NCT05424835

A Trial of SHR-A1811versus Pyrotinib in Combination With Capecitabine in HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane

A Phase 3 study testing SHR-A1811 and Pyrotinib in combination with Capecitabine. in people with HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane, 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

The study is being conducted to evaluate whether the efficacy of SHR-A1811 is better than Pyrotinib in combination with Capecitabine in HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane. Read more about this study

Who is it for?: Ages 18 to 75 years, women only
Conditions the study is for: HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane
What is being tested?: SHR-A1811 and Pyrotinib in combination with Capecitabine.
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 381 participants
Where: 1 siteChina
Study dates: 4 Aug 2022to 31 Dec 2027
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

Able and willing to provide a written informed consent;
Unresectable or metastatic HER2 positive breast cancer previously treated with Trastuzumab and Taxane in recurrence and metastasis stage;
Documented disease progression;
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
Life expectancy ≥ 12 weeks.
Subject has measurable disease based on RECIST v1.1;

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Important organ function can meet the criteria (no blood component and cell growth factor treatment within 14 days before the first study drug administration)
Pregnancy and Contraception:
Women of childbearing potential (WOCBP) must agree to use highly effective contraceptive measures and not to lactate from screening until 7 months after receiving the last treatment.
Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to the first study drug administration.

Who cannot join

Subjects with other malignant tumors in the past 5 years (except for the cured skin basal cell carcinoma and cervical carcinoma in situ).
There is a third interstitial effusion (e.g., massive ascites, pleural effusion, pericardial effusion) that cannot be controlled by drainage or other methods.
Inability to swallow, chronic diarrhea, intestinal obstruction, or other factors that affect drug administration and absorption.
Received mitomycin C and nitrosoureas chemotherapy within 6 weeks before the first study drug administration.
Any surgery (eg., major surgery for cancer), radiotherapy, chemotherapy, immunotherapy or molecular targeted therapy, biotherapy or other drug clinical trial within 4 weeks; received endocrine therapy within 2 weeks before the first study drug administration.
Any concurrent use of immunosuppressant or systemic corticosteroid treatment to achieve immunosuppression purpose (dose of > 10mg/day prednisone or equivalent), and still in use within 2 weeks before the first study drug administration.

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History of autoimmune disease with the possibility of recurrence or active autoimmune disease; subjects with skin diseases without systematic treatment such as vitiligo, psoriasis, alopecia, or controlled type I diabetes treated with insulin can be included; asthma completely relieved in childhood without any intervention in adult can be included, subjects that requires medical intervention with bronchodilators for asthma cannot be included).
History of immunodeficiency including seropositivity for human immunodeficiency virus (HIV) or other acquired or congenital immune-deficient disease, or organ transplantation.
Cardiac disease including myocardial infarction within a minimum 6 months before the first study drug administration, severe or unstable angina, symptomatic congestive heart failure (New York Heart Association [NYHA] classes ≥II), or clinically significant supraventricular or ventricular cardiac arrhythmia requiring treatment/intervention.
Subjects with known or suspected interstitiallung disease;
Active hepatitis B (HBsAg positive and HBV DNA ≥ 500 IU / ml), hepatitis C (hepatitis C antibody positive and HCV RNA higher than the detection limit of the analytical method), hepatic cirrhosis, or severe infections requiring antibiotic, antiviral or antifungal control.
Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI CTCAE v5.0 Grade ≤1 at baseline. Subjects with chronic Grade 2 toxicities may be eligible at the discretion of the investigator and discussion with sponsor.
Known history of severe allergy to study drug or its components, or allergy to humanized monoclonal antibody products (such as trastuzumab, pertuzumab, etc.).
The presence of other serious physical or mental disorders or abnormalities in laboratory tests that may increase the risk of study participation or interfere with study results, as well as patients deemed unsuitable for study participation by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510120

Other trials in China

About this study

Official title: A Phase III, Multicenter, Randomized, Open-Label, Parallel Controlled Study of SHR-A1811 Versus Pyrotinib in Combination With Capecitabine for HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane

Conditions: HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane
Being tested: SHR-A1811, Pyrotinib in combination with Capecitabine.

What participants receive

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

SHR-A1811Drug
SHR-A1811 4.8mg/kg
Pyrotinib in combination with Capecitabine.Drug
Pyrotinib in combination with Capecitabine.
SHR-A1811Drug
SHR-A1811 6.4mg/kg

Study groups in NCT05424835
Study group	Role	What they receive
Treatment group A	Experimental	SHR-A1811 4.8mg/kg Receives: Drug: SHR-A1811
Treatment group B	Active comparator	Pyrotinib in combination with Capecitabine. Receives: Drug: Pyrotinib in combination with Capecitabine.
Treatment group C	Experimental	SHR-A1811 6.4mg/kg Receives: Drug: SHR-A1811
Treatment group D	Active comparator	Pyrotinib in combination with Capecitabine. Receives: Drug: Pyrotinib in combination with Capecitabine.

What is being measured

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

PFS（BIRC assessment）between SHR-A1811 4.8mg/kg Q3W and Pyrotinib in combination with Capecitabine.
Measured: 6 weeks after the first study drug administration，about 2 years.

Secondary outcomes (10)

PFS（INV assessment）between SHR-A1811 4.8mg/kg Q3W and Pyrotinib in combination with Capecitabine
Measured: 6 weeks after the first study drug administration，about 2 years.
ORR between SHR-A1811 4.8mg/kg Q3W and Pyrotinib in combination with Capecitabine；
Measured: about 2 years.
DoR between SHR-A1811 4.8mg/kg Q3W and Pyrotinib in combination with Capecitabine；
Measured: about 2 years.
OS between SHR-A1811 4.8mg/kg Q3W and Pyrotinib in combination with Capecitabine；
Measured: about 4 years.
PFS（BIRC assessment）between SHR-A1811 6.4mg/kg Q3W and Pyrotinib in combination with Capecitabine；
Measured: 6 weeks after the first study drug administration，about 2 years.
PFS（INV assessment）between SHR-A1811 6.4mg/kg Q3W and Pyrotinib in combination with Capecitabine；
Measured: 6 weeks after the first study drug administration，about 2 years.
ORR between SHR-A1811 6.4mg/kg Q3W and Pyrotinib in combination with Capecitabine；
Measured: about 2 years.
DoR between SHR-A1811 6.4mg/kg Q3W and Pyrotinib in combination with Capecitabine；
Measured: about 2 years.
OS between SHR-A1811 6.4mg/kg Q3W and Pyrotinib in combination with Capecitabine；
Measured: about 4 years.
AE
Measured: about 2 years.

Timeline

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

4 Aug 202231 Dec 2027

First posted21 Jun 2022
Study start4 Aug 2022
Primary completion31 Dec 2026 (estimated)
Study completion31 Dec 2027 (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-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and TaxaneStudies 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
Model description: SHR-A1811 compared with Pyrotinib in combination with Capecitabine
Masking: None (open label)
Enrolment: 381 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05424835
Sponsor's protocol ID: SHR-A1811-III-301
Status last verified: Sep 2024
First submitted: 15 Jun 2022
Last updated: 22 Aug 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Yao H, Zhang Q, Li H, Yin Y, Wang S, Ouyang Q, Sun T, Li W, Wang X, Yan M, Wang B, Cheng J, Tong Z, Wei W, Wang X, Xie W, Sun Z, Yuan P, Geng C, Gan L, Han X, Li W, Zhou S, Yan X, Gao J, Yi T, Wu J, Niu Z, Fu F, Nie J, Wang Y, Zhao B, Wu Z, Zhu Z, Yang Y, Zhao J, Sheng Z, Zhang Y, Cheng L, Zhu X, Song E. Trastuzumab rezetecan versus pyrotinib plus capecitabine for patients with HER2-positive metastatic breast cancer (HORIZON-Breast01): interim analysis of a multicentre, open-label, randomised, controlled, phase 3 trial. Lancet Oncol. 2026 Aug;27(8):929-940. doi: 10.1016/S1470-2045(26)00193-2. Epub 2026 Jul 1.
PubMed 42385760

Study at a glance

From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Multicenter, Randomized, Open-Label, Parallel Controlled Study of SHR-A1811 Versus Pyrotinib in Combination With Capecitabine for HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane
ClinicalTrials.gov ID: NCT05424835
Acronym / sponsor ID: SHR-A1811-III-301
Conditions: HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane
Phase: Phase 3
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 381 participants (actual)
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
Study start: 4 Aug 2022 (actual)
Primary completion: 31 Dec 2026 (estimated)
Study completion: 31 Dec 2027 (estimated)
First posted: 21 Jun 2022 (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: 4
Model description: SHR-A1811 compared with Pyrotinib in combination with Capecitabine

Arm	Type	Receives
Treatment group A	Experimental	Drug: SHR-A1811SHR-A1811 4.8mg/kg
Treatment group B	Active comparator	Drug: Pyrotinib in combination with Capecitabine.Pyrotinib in combination with Capecitabine.
Treatment group C	Experimental	Drug: SHR-A1811SHR-A1811 6.4mg/kg
Treatment group D	Active comparator	Drug: Pyrotinib in combination with Capecitabine.Pyrotinib in combination with Capecitabine.

Who may qualify

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

Key inclusion criteria (10 listed)

Able and willing to provide a written informed consent;
Unresectable or metastatic HER2 positive breast cancer previously treated with Trastuzumab and Taxane in recurrence and metastasis stage;
Documented disease progression;
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
Life expectancy ≥ 12 weeks.

Key exclusion criteria (14 listed)

Subjects with other malignant tumors in the past 5 years (except for the cured skin basal cell carcinoma and cervical carcinoma in situ).
There is a third interstitial effusion (e.g., massive ascites, pleural effusion, pericardial effusion) that cannot be controlled by drainage or other methods.
Inability to swallow, chronic diarrhea, intestinal obstruction, or other factors that affect drug administration and absorption.
Received mitomycin C and nitrosoureas chemotherapy within 6 weeks before the first study drug administration.
Any surgery (eg., major surgery for cancer), radiotherapy, chemotherapy, immunotherapy or molecular targeted therapy, biotherapy or other drug clinical trial within 4 weeks; received endocrine therapy within 2 weeks before the first study drug administration.

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-A1811SHR-A1811 4.8mg/kg	Drug	Treatment group A
Pyrotinib in combination with Capecitabine.Pyrotinib in combination with Capecitabine.	Drug	Treatment group B, Treatment group D
SHR-A1811SHR-A1811 6.4mg/kg	Drug	Treatment group C

Primary outcome

PFS（BIRC assessment）between SHR-A1811 4.8mg/kg Q3W and Pyrotinib in combination with Capecitabine.
Time frame: 6 weeks after the first study drug administration，about 2 years.

10 secondary outcomes

PFS（INV assessment）between SHR-A1811 4.8mg/kg Q3W and Pyrotinib in combination with Capecitabine
Time frame: 6 weeks after the first study drug administration，about 2 years.
ORR between SHR-A1811 4.8mg/kg Q3W and Pyrotinib in combination with Capecitabine；
Time frame: about 2 years.
DoR between SHR-A1811 4.8mg/kg Q3W and Pyrotinib in combination with Capecitabine；
Time frame: about 2 years.
OS between SHR-A1811 4.8mg/kg Q3W and Pyrotinib in combination with Capecitabine；
Time frame: about 4 years.
PFS（BIRC assessment）between SHR-A1811 6.4mg/kg Q3W and Pyrotinib in combination with Capecitabine；
Time frame: 6 weeks after the first study drug administration，about 2 years.
PFS（INV assessment）between SHR-A1811 6.4mg/kg Q3W and Pyrotinib in combination with Capecitabine；
Time frame: 6 weeks after the first study drug administration，about 2 years.
ORR between SHR-A1811 6.4mg/kg Q3W and Pyrotinib in combination with Capecitabine；
Time frame: about 2 years.
DoR between SHR-A1811 6.4mg/kg Q3W and Pyrotinib in combination with Capecitabine；
Time frame: about 2 years.
OS between SHR-A1811 6.4mg/kg Q3W and Pyrotinib in combination with Capecitabine；
Time frame: about 4 years.
AE
Time frame: about 2 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 22 Aug 2025.
Derived from this study: PubMed 42385760Yao H, Zhang Q, Li H, Yin Y, Wang S, Ouyang Q, Sun T, Li W, Wang X, Yan M, Wang B, Cheng J, Tong Z, Wei W, Wang X, Xie W, Sun Z, Yuan P, Geng C, Gan L, Han X, Li W, Zhou S, Yan X, Gao J, Yi T, Wu J, Niu Z, Fu F, Nie J, Wang Y, Zhao B, Wu Z, Zhu Z, Yang Y, Zhao J, Sheng Z, Zhang Y, Cheng L, Zhu X, Song E. Trastuzumab rezetecan versus pyrotinib plus capecitabine for patients with HER2-positive metastatic breast cancer (HORIZON-Breast01): interim analysis of a multicentre, open-label, randomised, controlled, phase 3 trial. Lancet Oncol. 2026 Aug;27(8):929-940. doi: 10.1016/S1470-2045(26)00193-2. Epub 2026 Jul 1.
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?

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 10 inclusion and 14 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 22 Aug 2025. 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?

PFS（BIRC assessment）between SHR-A1811 4.8mg/kg Q3W and Pyrotinib in combination with Capecitabine. (time frame: 6 weeks after the first study drug administration，about 2 years.). 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 NCT05424835, 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 22 Aug 2025.