A Phase III Study of SHR-A1811 Injection With or Without Pertuzumab in HER2-Positive Recurrent or Metastatic Breast Cancer

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

Study Overview

• Status: Active, not recruiting
• Conditions: HER2-PositiveRecurrent or Metastatic Breast Cancer
• Intervention / Treatment: Drug: SHR-A1811 Injection; Drug: SHR-A1811 Injection ； Pertuzumab Injection; Drug: Trastuzumab Injection；Pertuzumab Injection ； Docetaxel Injection

• Study Type: Interventional
• Enrollment (Actual): 868
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • The First Affiliated Hospital of Nanjing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Women aged 18 to 75 (inclusive)
2. HER2 positive (IHC3+ or ISH+) unresectable or metastatic breast cancer confirmed by histology or cytology.
3. ECOG score is 0 or 1
4. An expected survival of ≥ 12 weeks
5. At least one measurable lesion according to RECIST v1.1 criteria
6. Have adequate renal and hepatic function
7. Patients voluntarily joined the study and signed informed consent

Exclusion Criteria:

1. Have other malignancies within the past 5 years
2. Active central nervous system metastasis without surgery or radiotherapy
3. In (neoadjuvant) adjuvant therapy phase, the interval from the end of systemic therapy (excluding endocrine therapy) to the detection of recurrence/metastasis ≤12 months
4. Presence with uncontrollable third space effusion
5. Have undergone other anti-tumor treatment within 4 weeks before the first dose
6. A history of immune deficiency
7. Clinically significant cardiovascular disorders
8. Known or suspected interstitial lung disease
9. The toxicity from previous anti-tumor treatment has not recovered to ≤ grade I
10. Known hereditary or acquired bleeding tendency
11. Active hepatitis and liver cirrhosis
12. Presence of other serious physical or mental diseases or laboratory abnormalities

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group A: SHR-A1811 Injection	Drug: SHR-A1811 Injection; SHR-A1811 Injection
Experimental: Treatment group B: SHR-A1811 Injection and Pertuzumab Injection	Drug: SHR-A1811 Injection ； Pertuzumab Injection; SHR-A1811 Injection ； Pertuzumab Injection
Active Comparator: Treatment group C: Trastuzumab Injection, Pertuzumab Injection and Docetaxel Injection	Drug: Trastuzumab Injection；Pertuzumab Injection ； Docetaxel Injection; Trastuzumab Injection；Pertuzumab Injection ； Docetaxel Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression Free Survival by Blinded Independent Central Review	from first dose to disease progression, or death, whichever comes first, up to 3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Progression Free Survival by investigators	from first dose to disease progression, or death, whichever comes first, up to 3 years
Overall Survival	from first dose to death, up to 6 years
Objective Response Rate	from first dose to disease progression or death, whichever comes first, up to 3 years
Duration of response	from first dose to disease progression or death, whichever comes first, up to 3 years
AE	from Day1 to 40 or 90 days after last dose
Incidence and severity of serious adverse events (SAE)	from Day1 to 40 or 90 days after last dose

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2023
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2032

Study Registration Dates

• First Submitted: September 11, 2023
• First Submitted That Met QC Criteria: September 21, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Antineoplastic Agents, Immunological; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel; Trastuzumab; Pertuzumab
• Other Study ID Numbers: SHR-A1811-307

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No