Breast CancerPhase 3NCT05814354
SHR-A1811 Versus Investigator's Chemotherapy in Recurrent/Metastatic Breast Cancer Clinical Trial
A Phase 3 study testing SHR-A1811 and Capecitabine/Eribulin/Gemcitabine/Paclitaxel/Nab-paclitaxel in people with Breast Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The aim of this study was to evaluate whether the progression-free survival of SHR-A1811 was superior to investigator-selected chemotherapy in patients with HER2-low recurrent/metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- SHR-A1811 and Capecitabine/Eribulin/Gemcitabine/Paclitaxel/Nab-paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 551 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2023to 30 Jun 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
- Low-HER2 expression defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested).
- HR-positive breast cancer with at least one endocrine therapy and disease progression was judged by the investigator to no longer benefit from endocrine therapy.
- Has been treated with 0 to 1 prior lines of chemotherapy in the metastatic setting.
- Has documented radiologic progression (during or after most recent treatment).
- Has at least 1 protocol-defined measurable lesion.
- Has protocol-defined adequate cardiac, bone marrow, renal, hepatic and blood clotting functions.
- Fertile women (WOCBP) subjects agreed to use highly effective contraception and not to breastfeed from the time of study screening until 7 months after receiving the last study medication; a fertile woman must have a negative serum pregnancy test result within 7 days prior to the first treatment.
Who cannot join
- Has known active central nervous system (CNS) metastases. Subjects with previously treated brain metastases may participate provided they are stable.
- A history of human immunodeficiency virus (HIV) infection is known, or has an active autoimmune disease.
- History of interstitial lung disease or pneumonia requiring oral or intravenous steroids.
- Has moderate or severe cardiovascular disease.
- Active HBV(hepatitis B) or HCV (Hepatitis C virus)-infected subjects.
- Any other malignancies within 5 years except for those with negligible risk of metastasis or death.
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
About this study
Official title: A Randomized, Open, Parallel-controlled, Multicenter Phase III Trial of SHR-A1811 Versus Investigator Chemotherapy in HER2-low Expressing Recurrent/Metastatic Breast Cancer
The aim of this study was to evaluate whether the progression-free survival of SHR-A1811 was superior to investigator-selected chemotherapy in patients with HER2-low recurrent/metastatic breast cancer. To evaluate whether SHR-A1811 is superior to investigator-selected chemotherapy in patients with HER2-low recurrent/metastatic breast cancer.
- Conditions
- Breast Cancer
- Being tested
- SHR-A1811, Capecitabine/Eribulin/Gemcitabine/Paclitaxel/Nab-paclitaxel
- 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-A1811Drug
SHR-A1811 is a lyophilized powder for injection intravenously. Administered according to label, as one option for Physician's Choice.
Capecitabine/Eribulin/Gemcitabine/Paclitaxel/Nab-paclitaxelDrug
Administered according to label, as one option for Physician's Choice (determined before randomization).
| Study group | Role | What they receive |
|---|---|---|
| SHR-A1811 | Experimental | Not described Receives: Drug: SHR-A1811 |
| Physician's Choice | Active comparator | Capecitabine/Eribulin/Gemcitabine/Paclitaxel/Nab-paclitaxel Receives: Drug: Capecitabine/Eribulin/Gemcitabine/Paclitaxel/Nab-paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS) Based on Blind Independent Video Review Committee (BIRC)
Measured: within approximately 2 years
Secondary outcomes (4)
Overall Survival (OS)
Time from the date of randomization to the date of death for any cause. If there is no death reported for a participant before the data cutoff for OS analysis, OS will be censored at the last contact date at which the participant is known to be alive.
Measured: within approximately 3 years
Objective Response Rate (ORR)
Percentage of participants who achieved a best overall response of complete response (CR) or partial response (PR), confirmed by a second assessment.
Measured: within approximately 2 years
Duration of Response (DoR)
DoR is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death.
Measured: within approximately 2 years
Clinical Benefit Rate (CBR)
CBR is defined as complete response (CR), partial response (PR), or stable disease (SD) according to RECIST 1.1.
Measured: within approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start30 Jun 2023
- Primary completion20 Mar 2026
- Study completion30 Jun 2028 (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 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
- Model description
- Parallel model, randomized at a 1:1 ratio
- Masking
- None (open label)
- Enrolment
- 551 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
- NCT05814354
- Sponsor's protocol ID
- SHR-A1811-III-306
- Status last verified
- Aug 2026
- First submitted
- 3 Apr 2023
- Last updated
- 6 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fan Y, Liu Y, Wang Y, Ouyang Q, Zhang Q, Cui J, Li J, Ding Q, Wu X, Wang X, Tong Z, Zeng Y, Wang W, Yan M, Wang Y, Liu X, Li K, Sun Z, Yuan C, Wang T, Xie W, Yao J, Zhou S, Hou J, Ouyang Z, Li Y, Cui S, Zhang X, Zhu X, Xu B. Trastuzumab Rezetecan in ERBB2-Low Advanced Breast Cancer: The HORIZON-Breast06 Randomized Clinical Trial. JAMA. 2026 Oct 23:e2621372. doi: 10.1001/jama.2026.21372. Online ahead of print.
PubMed 42925007
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open, Parallel-controlled, Multicenter Phase III Trial of SHR-A1811 Versus Investigator Chemotherapy in HER2-low Expressing Recurrent/Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT05814354
- Acronym / sponsor ID
- SHR-A1811-III-306
- Conditions
- Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 551 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2023 (actual)
- Primary completion
- 20 Mar 2026 (actual)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 14 Apr 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.
The aim of this study was to evaluate whether the progression-free survival of SHR-A1811 was superior to investigator-selected chemotherapy in patients with HER2-low recurrent/metastatic breast cancer. To evaluate whether SHR-A1811 is superior to investigator-selected chemotherapy in patients with HER2-low recurrent/metastatic breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel model, randomized at a 1:1 ratio
| Arm | Type | Receives |
|---|---|---|
| SHR-A1811 | Experimental | Drug: SHR-A1811 |
| Physician's Choice | Active comparator | Drug: Capecitabine/Eribulin/Gemcitabine/Paclitaxel/Nab-paclitaxelCapecitabine/Eribulin/Gemcitabine/Paclitaxel/Nab-paclitaxel |
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)
- Low-HER2 expression defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested).
- HR-positive breast cancer with at least one endocrine therapy and disease progression was judged by the investigator to no longer benefit from endocrine therapy.
- Has been treated with 0 to 1 prior lines of chemotherapy in the metastatic setting.
- Has documented radiologic progression (during or after most recent treatment).
- Has at least 1 protocol-defined measurable lesion.
Key exclusion criteria (6 listed)
- Has known active central nervous system (CNS) metastases. Subjects with previously treated brain metastases may participate provided they are stable.
- A history of human immunodeficiency virus (HIV) infection is known, or has an active autoimmune disease.
- History of interstitial lung disease or pneumonia requiring oral or intravenous steroids.
- Has moderate or severe cardiovascular disease.
- Active HBV(hepatitis B) or HCV (Hepatitis C virus)-infected subjects.
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 is a lyophilized powder for injection intravenously. Administered according to label, as one option for Physician's Choice. | Drug | SHR-A1811 |
| Capecitabine/Eribulin/Gemcitabine/Paclitaxel/Nab-paclitaxelAdministered according to label, as one option for Physician's Choice (determined before randomization). | Drug | Physician's Choice |
Primary outcome
Progression-free Survival (PFS) Based on Blind Independent Video Review Committee (BIRC)
Time frame: within approximately 2 years
4 secondary outcomes
Overall Survival (OS)
Time frame: within approximately 3 years
Objective Response Rate (ORR)
Time frame: within approximately 2 years
Duration of Response (DoR)
Time frame: within approximately 2 years
Clinical Benefit Rate (CBR)
Time frame: within approximately 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 6 Aug 2026.
- Derived from this study: PubMed 42925007Fan Y, Liu Y, Wang Y, Ouyang Q, Zhang Q, Cui J, Li J, Ding Q, Wu X, Wang X, Tong Z, Zeng Y, Wang W, Yan M, Wang Y, Liu X, Li K, Sun Z, Yuan C, Wang T, Xie W, Yao J, Zhou S, Hou J, Ouyang Z, Li Y, Cui S, Zhang X, Zhu X, Xu B. Trastuzumab Rezetecan in ERBB2-Low Advanced Breast Cancer: The HORIZON-Breast06 Randomized Clinical Trial. JAMA. 2026 Oct 23:e2621372. doi: 10.1001/jama.2026.21372. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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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 and Capecitabine/Eribulin/Gemcitabine/Paclitaxel/Nab-paclitaxel in people with 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 6 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 6 Aug 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 (PFS) Based on Blind Independent Video Review Committee (BIRC) (time frame: within approximately 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 NCT05814354, 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 6 Aug 2026.