Health TrialsbyHealthPanel

Phase II Study of SHR-A1811 for Ultra-Low HER2 Advanced Breast Cancer

ConditionAdvanced Breast Cancer With Ultra-Low HER2 Expression
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorTianjin Medical University Cancer Institute and Hospital

About this trial

This is a single-center, single-arm, open-label phase II exploratory study. A total of 30 patients aged 18-75 years with ECOG PS 0-1, pathologically confirmed advanced breast cancer with ultra-low HER2 expression will be enrolled. Eligible patients must have at least one measurable lesion and have received 1-2 lines of prior systemic therapy for advanced disease. All participants receive intravenous SHR-A1811 at 4.8 mg/kg every 3 weeks, until disease progression, intolerable adverse events or other discontinuation criteria. The primary endpoint is objective response rate (ORR). Secondary endpoints include progression-free survival (PFS), overall survival (OS), duration of response (DOR), disease control rate (DCR), clinical benefit rate (CBR), and safety profile.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female subjects, aged ≥18 years and ≤75 years;

ECOG performance status 0-1;

Expected survival of no less than 3 months;

Advanced or metastatic breast cancer

Disqualifiers

According to ASCO/CAP guidelines, subjects whose tumor has never been reported as HER2-positive (IHC 3+ or ISH-amplified);

HR-positive patients who have received systemic chemotherapy in the advanced-disease setting;<br/>Prior anti-HER2 therapy; prior or ongoing treatment with antibody-drug conjugates containing exatecan derivatives (topoisomerase I inhibitors), including DS-8201a, Sacituzumab govitecan (SG), etc.;

Known history of severe hypersensitivity to the drug substance, inactive ingredients in the pharmaceutical formulation, or other monoclonal antibodies;

Received local radiotherapy, endocrine therapy, or oral small-molecule targeted anti-tumor therapy within 14 days prior to first study drug administration;

Trial design

Design model

Single group

Treatments tested in this trial

  • SHR- A1811

    Drug

    4.8 mg/kg, intravenous infusion, administered every 3 weeks. Treatment continues until disease progression, intolerable adverse events, withdrawal of consent or death.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: SHR-A1811 Experimental Treatment ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective Response Rate (ORR)

Response rate (CR+PR) assessed per RECIST Version 1.1

Time frame
Up to 24 months

Secondary outcomes

1

Progression-Free Survival (PFS)

Time from enrollment to disease progression or death, whichever occurs first, per RECIST Version 1.1

Time frame
Time Frame: Up to 24 months
2

Overall Survival (OS)

Time from enrollment to death from any cause

Time frame
Up to 24 months
3

Duration of Response (DOR)

Time from first documented CR/PR to disease progression or death, per RECIST Version 1.1

Time frame
Up to 24 months
4

Disease Control Rate (DCR)

DCR defined as CR+PR+SD ≥6 weeks per RECIST Version 1.1

Time frame
Up to 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tianjin Medical University Cancer Institute and Hospital

Lead sponsor

Source ClinicalTrials.gov
Apply now