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

Phase 3

Recruiting

• Conditions: HER2-PositiveRecurrent or Metastatic Breast Cancer
• Interventions: Drug: Trastuzumab Injection；Pertuzumab Injection ； Docetaxel Injection; Drug: SHR-A1811 Injection ； Pertuzumab Injection; Drug: SHR-A1811 Injection

• Registration Number: NCT06057610
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-11
• Study First Submitted QC: 2023-09-21
• Study First Posted: 2023-09-28
• Study Start: 2023-10-16
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-20
• Primary Completion: 2027-10
• Study Completion: 2032-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 864

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group C: Trastuzumab Injection, Pertuzumab Injection and Docetaxel Injection	Trastuzumab Injection；Pertuzumab Injection ； Docetaxel Injection	-
Treatment group B: SHR-A1811 Injection and Pertuzumab Injection	SHR-A1811 Injection ； Pertuzumab Injection	-
Treatment group A: SHR-A1811 Injection	SHR-A1811 Injection	-

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

The First Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China