SHR-A1811 vs Pyrotinib/Capecitabine in Trastuzumab-Resistant HER2+ Advanced Breast Cancer: A Randomized Study

Conditions

• Breast Cancer
• HER2-positive Breast Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• SHR-A1811 — DRUG
  4.8 mg/kg administered as an intravenous infusion on Day 1 of each cycle. 3 weeks a cycle. Continuous medication until study completion, occurrence of intolerable toxicity, disease progression, withdrawal from the study for any reason, or death, whichever occurs first, or until the investigator deems that the patient would no longer benefit from the treatment.
• Pyrotinib — DRUG
  400 mg, administered orally once daily, continuous medication until study completion, occurrence of intolerable toxicity, disease progression, withdrawal from the study for any reason, or death, whichever occurs first, or until the investigator deems that the patient would no longer benefit from the treatment.
• Capecitabine — DRUG
  1000mg/m2, administered orally twice daily on Days 1-14, with no administration on Days 15-21, 3 weeks a cycle. Continuous medication until study completion, occurrence of intolerable toxicity, disease progression, withdrawal from the study for any reason, or death, whichever occurs first, or until the investigator deems that the patient would no longer benefit from the treatment.
• T-DXd — DRUG
  5.4 mg/kg administered as an intravenous infusion on Day 1 of each cycle. 3 weeks a cycle. Continuous medication until study completion, occurrence of intolerable toxicity, disease progression, withdrawal from the study for any reason, or death, whichever occurs first, or until the investigator deems that the patient would no longer benefit from the treatment.

Study Details

This is a prospective, multicenter, open-label, randomized, controlled Study. The purpose of this study is to evaluate the efficacy and safety of SHR-A1811 versus pyrotinib plus capecitabine in the treatment of trastuzumab primary-resistant HER2-positive advanced breast cancer.

Key Dates

First listed

Feb 18, 2026

Start date

Mar 31, 2026

Status verified

Feb 2026

Primary completion

Jan 31, 2029

Completion

Dec 31, 2029

Study Design

Enrollment

100 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm 1
  Treatment Phase 1: SHR-A1811 monotherapy until progression or intolerable adverse events. Treatment Phase 2: Switch to pyrotinib plus capecitabine upon progression from Phase 1, continued until subsequent progression or intolerable adverse events.
• Active Comparator: Arm 2
  Treatment Phase 1: Pyrotinib plus capecitabineuntil progression or intolerable adverse events. Treatment Phase 2: Switch to T-DXd upon progression from Phase 1, continued until subsequent progression or intolerable adverse events.

Primary Outcome Measure

PFS during treatment phase 1 [ Time Frame: Start of treatment until 2-year follow-up ]

Central Contacts

• Hanfang Jiang
  +86-010-88196380
  [email protected]

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