Not Yet RecruitingPhase 2

SHR-A1811 Combine With Pyrotinib for Locally Advanced/Metastatic HER2 Positive Breast Cancer

84 participantsStarted 2025-08-30

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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…

What they're measuring

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Timeframe: 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

Timeframe: from initiation of the study treatment until disease progression (or treatment discontinuation), the observation period is up to 36 months.

Trial details

NCT IDNCT07132242

SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-08-30

View on ClinicalTrials.gov More Metastatic Breast Cancer With HER2 Positive trials