SHR-A1811 Combine With Pyrotinib for Locally Advanced/Metastatic HER2 Positive Breast Cancer
Safety and Efficacy of SHR-A1811 Combine With Pyrotinib for the Treatment of HER2 Positive Locally Advanced or Metastatic Breast Cancer, a Phase II Study
1 other identifier
interventional
84
0 countries
N/A
Brief Summary
The goal of this clinical trial is to learn if SHR-A1811 combine with Pyrotinib is safe and tolerable for patients with HER2 positive breast cancer. It will also learn about the anti-tumor efficacy of this combination therapy. Participants will take SHR-A1811 and pyrotinib every three weeks, until disease progression or intolerable toxicity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2025
Typical duration for phase_2
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
First Submitted
Initial submission to the registry
August 1, 2025
CompletedFirst Posted
Study publicly available on registry
August 20, 2025
CompletedStudy Start
First participant enrolled
August 30, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
August 20, 2025
August 1, 2025
3 years
August 1, 2025
August 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
the proportion of patients who experienced treatment-emergent adverse events during the study treatment among the total number of patients experienced study treatment.
From the date of signing ICF until the end of the safety follow-up period, defined as 40 days after the last administration of SHR-A1811 or Pyrotinib
ORR
Objective Response Rate: The proportion of subjects achieving a best overall response(per RECIST v1.1) of complete response (CR) or partial response (PR) during the period from initiation of the study treatment until disease progression (or treatment discontinuation), relative to the total number of subjects in the analysis set.
from initiation of the study treatment until disease progression (or treatment discontinuation), the observation period is up to 36 months.
Secondary Outcomes (3)
PFS
from the date of enrollment until the first documented radiological disease progression (PD) or death from any cause, the observation period is up to 36 months.
OS
The time from the date of enrollment to the date of death due to any cause. The observation period is up to 60 months.
DoR
from the date of first documented response to the date of disease progression or death of any cause, the observation period is up to 36 months.
Study Arms (4)
Arm 1：SHR-A1811 4.0mg/kg + Pyrotinib 240mg/Day
EXPERIMENTALArm 2：SHR-A1811 4.0mg/kg + Pyrotinib 320mg/Day
EXPERIMENTALArm 3: SHR-A1811 4.8mg/kg + Pyrotinib 240mg/Day
EXPERIMENTALArm4: SHR-A1811 4.8mg/kg + Pyrotinib 320mg/Day
EXPERIMENTALInterventions
SHR-A1811 4.0mg/kg, IV, Day 1, Q3W
Pyrotinib 240mg, po, QD, from Day 8 to Day 21,Q3W
SHR-A1811 4.8mg/kg, IV, D1, Q3W
Pyrotinib 320mg, po, QD, from Day 8 to Day 21, Q3W
Eligibility Criteria
You may qualify if:
- Age: ≥18 years old and ≤70 years old;
- Pathologically confirmed HER2-positive locally advanced or metastatic breast cancer;
- Progression during or after prior HER2-targeted therapy and chemotherapy in the advanced/metastatic setting OR progression during/within 12 months after completion of trastuzumab and taxane-based chemotherapy in the neoadjuvant/adjuvant setting OR after 2 cycles of trastuzumab and taxane-based chemotherapy in the neoadjuvant setting with suboptimal response (assessed as non-response) for locally advanced disease;
- At least one measurable lesion per RECIST v1.1 criteria.
- ECOG performance status of 0 or 1.
- Adequate Organ Function
- Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose. Male subjects with partners of childbearing potential must be surgically sterile or agree to use effective contraception during the trial. Sperm donation is not permitted during the study period.
- Subjects must voluntarily enroll in this study, sign the informed consent form, demonstrate good compliance, and be willing to cooperate with follow-up.
You may not qualify if:
- Prior Pyrotinib in Advanced/Metastatic Setting;
- Prior Tropoisomerase I Inhibitor ADC Therapy;
- Active CNS Metastases;
- Other Malignancy;
- Recent Major Surgery/Trauma;
- Interstitial Lung Disease (ILD)/Severe Pulmonary Conditions;
- Significant Cardiac Disease;
- Inability to swallow oral medication, chronic diarrhea, intestinal obstruction, or other factors significantly affecting drug ingestion or absorption;
- Known hypersensitivity to any component of the investigational drugs in this study protocol;
- Immunodeficiency/Organ Transplant;
- Uncontrolled Third-Space Fluid Accumulation;
- Pregnancy/Breastfeeding/Contraception;
- Severe concomitant illness or comorbid conditions that may interfere with planned treatment or preclude study participation, as assessed by the investigator. This includes, but is not limited to, active hepatitis B or pulmonary infection requiring treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief Physician
Study Record Dates
First Submitted
August 1, 2025
First Posted
August 20, 2025
Study Start
August 30, 2025
Primary Completion (Estimated)
August 30, 2028
Study Completion (Estimated)
December 31, 2028
Last Updated
August 20, 2025
Record last verified: 2025-08