NCT06057610

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
868

participants targeted

Target at P75+ for phase_3

Timeline
78mo left

Started Oct 2023

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress29%
Oct 2023Oct 2032

First Submitted

Initial submission to the registry

September 11, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 28, 2023

Completed
18 days until next milestone

Study Start

First participant enrolled

October 16, 2023

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2032

Last Updated

March 11, 2026

Status Verified

April 1, 2025

Enrollment Period

4 years

First QC Date

September 11, 2023

Last Update Submit

March 9, 2026

Conditions

HER2-PositiveRecurrent or Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Progression Free Survival by Blinded Independent Central Review

    from first dose to disease progression, or death, whichever comes first, up to 3 years

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (3)

Treatment group A: SHR-A1811 Injection

EXPERIMENTAL
Drug: SHR-A1811 Injection

Treatment group B: SHR-A1811 Injection and Pertuzumab Injection

EXPERIMENTAL
Drug: SHR-A1811 Injection ； Pertuzumab Injection

Treatment group C: Trastuzumab Injection, Pertuzumab Injection and Docetaxel Injection

ACTIVE COMPARATOR
Drug: Trastuzumab Injection；Pertuzumab Injection ； Docetaxel Injection

Interventions

SHR-A1811 InjectionDRUG

SHR-A1811 Injection

Treatment group A: SHR-A1811 Injection
SHR-A1811 Injection ； Pertuzumab InjectionDRUG

SHR-A1811 Injection ； Pertuzumab Injection

Treatment group B: SHR-A1811 Injection and Pertuzumab Injection
Trastuzumab Injection；Pertuzumab Injection ； Docetaxel InjectionDRUG

Trastuzumab Injection；Pertuzumab Injection ； Docetaxel Injection

Treatment group C: Trastuzumab Injection, Pertuzumab Injection and Docetaxel Injection

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2023

First Posted

September 28, 2023

Study Start

October 16, 2023

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2032

Last Updated

March 11, 2026

Record last verified: 2025-04

Locations

CN(1)