RecruitingPhase 2NCT07393425

Neoadjuvant Trastuzumab Deruxtecan (SHR-A1811) + Pertuzumab in HER2+ Breast Cancer

Neoadjuvant Therapy With Trastuzumab Deruxtecan (SHR-A1811) + Pertuzumab or Trastuzumab Deruxtecan (SHR-A1811) + Pertuzumab Sequenced With Paclitaxel-based Regimens + Trastuzumab + Pyrotinib in HER2+ Breast Cancer

Sponsor

Shanghai Jiao Tong University School of Medicine

Enrollment

50 participants

Start Date

Feb 2, 2026

Study Type

INTERVENTIONAL

Conditions

HER2 + Breast Cancer

Summary

Patients with Stage II-III HER2-positive breast cancer will receive three cycles of treatment with Trastuzumab Deruxtecan (SHR-A1811) + Pertuzumab, followed by imaging assessment. If clinical complete response (cCR) or radiological complete response/near radiological complete response (rCR/near rCR) is achieved, they will continue to receive an additional three cycles of treatment with Trastuzumab Deruxtecan (SHR-A1811) + Pertuzumab, followed by surgery. If cCR/rCR or near rCR is not achieved, the treatment will be switched to the THPy regimen (paclitaxel-based regimen + Trastuzumab + Pyrotinib) for three cycles.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether a combination of trastuzumab deruxtecan (SHR-A1811, a targeted chemotherapy-antibody drug) plus pertuzumab (another targeted antibody) given before surgery can shrink HER2-positive breast cancer more effectively than standard neoadjuvant (pre-surgery) treatment. **You may be eligible if...** - You are a woman aged 18 to 70 - You have been diagnosed with invasive breast cancer confirmed by biopsy - Your cancer tests positive for HER2 (immunohistochemistry 3+, or 2+ with positive ISH test) - Your cancer is stage II or III - You have not yet received any treatment for breast cancer - You have at least one measurable tumor and adequate organ function **You may NOT be eligible if...** - You have already received chemotherapy, immunotherapy, or other breast cancer treatment - Your cancer is HER2-negative or stage I / stage IV - You have serious heart problems (low ejection fraction or uncontrolled arrhythmia) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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