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Active, not recruitingNCT05814354Updated Aug 6, 2026

SHR-A1811 Versus Investigator's Chemotherapy in Recurrent/Metastatic Breast Cancer Clinical Trial

A Phase 3 interventional study of SHR-A1811 and Capecitabine/Eribulin/Gemcitabine/Paclitaxel/Nab-paclitaxel in Breast Cancer, sponsored by Jiangsu HengRui Medicine Co., Ltd.. Active, not recruiting at 1 site in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-06.

Sponsored by Jiangsu HengRui Medicine Co., Ltd. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
551
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
Female
01

Study 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. To evaluate whether SHR-A1811 is superior to investigator-selected chemotherapy in patients with HER2-low recurrent/metastatic breast cancer.

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Conditions studied

  • Breast Cancer

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03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 551 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd. is the lead sponsor of 559 studies on the registry; 85 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  1. Low-HER2 expression defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested).
  2. 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.
  3. Has been treated with 0 to 1 prior lines of chemotherapy in the metastatic setting.
  4. Has documented radiologic progression (during or after most recent treatment).
  5. Has at least 1 protocol-defined measurable lesion.
  6. Has protocol-defined adequate cardiac, bone marrow, renal, hepatic and blood clotting functions.
  7. 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.

Exclusion criteria

Exclusion Criteria:

  1. Has known active central nervous system (CNS) metastases. Subjects with previously treated brain metastases may participate provided they are stable.
  2. A history of human immunodeficiency virus (HIV) infection is known, or has an active autoimmune disease.
  3. History of interstitial lung disease or pneumonia requiring oral or intravenous steroids.
  4. Has moderate or severe cardiovascular disease.
  5. Active HBV(hepatitis B) or HCV (Hepatitis C virus)-infected subjects.
  6. Any other malignancies within 5 years except for those with negligible risk of metastasis or death.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
551 participants (actual)

Study arms

  • Experimental
    SHR-A1811

    Drug: SHR-A1811

  • Active comparator
    Physician's Choice

    Capecitabine/Eribulin/Gemcitabine/Paclitaxel/Nab-paclitaxel

    Drug: Capecitabine/Eribulin/Gemcitabine/Paclitaxel/Nab-paclitaxel

Interventions

  • DrugSHR-A1811

    SHR-A1811 is a lyophilized powder for injection intravenously. Administered according to label, as one option for Physician's Choice.

  • DrugCapecitabine/Eribulin/Gemcitabine/Paclitaxel/Nab-paclitaxel

    Administered according to label, as one option for Physician's Choice (determined before randomization).

06

What researchers measure

Primary outcomes

  1. Progression-free Survival (PFS) Based on Blind Independent Video Review Committee (BIRC)

    Time frame: within approximately 2 years

Secondary outcomes

  1. 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.

    Time frame: within approximately 3 years

  2. 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.

    Time frame: within approximately 2 years

  3. 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.

    Time frame: within approximately 2 years

  4. Clinical Benefit Rate (CBR)

    CBR is defined as complete response (CR), partial response (PR), or stable disease (SD) according to RECIST 1.1.

    Time frame: within approximately 2 years

07

Study locations

1 site
  • Cancer Hospital Chinese Academy of Medical Sciences
    Beijing, Beijing Municipality 100021, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05814354
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
Responsible party
Sponsor
First posted
Apr 14, 2023
Start date
Jun 30, 2023
Primary completion
Mar 20, 2026
Completion
Jun 30, 2028 (estimated)
Last update
Aug 6, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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