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

Sponsor
Shanghai Jiao Tong University School of Medicine
Study ID
NCT07393425
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • HER2 + Breast Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Trastuzumab Deruxtecan — DRUG
    4.8mg/kg, d1, q3w
  • Pertuzumab — DRUG
    840mg on cycle1, 420mg on following cycles, d1, q3w
  • Taxane Chemotherapy — DRUG
    Nab-paclitaxel 100 mg per square meter, d1,d8,d15 q3w Or Paclitaxel 80mg per square meter, d1,d8,d15 q3w Or Docetaxel 100mg per square meter, d1 q3w
  • Trastuzumab (or biosimilar) — DRUG
    Trastuzumab 8mg/kg (loading dose) or 6mg/kg on following cycles, d1, q3w
  • Pyrotinib 320mg — DRUG
    320mg qd

Study Details

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.

Key Dates

Start date
Feb 2, 2026
Status verified
Feb 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2032

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Study Arm
    Patients 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.Patients who did not achieve cCR/rCR or near rCR at the end of cycle 3 will change to the THPy regimen (paclitaxel-based regimen + Trastuzumab + Pyrotinib) for three cycles.

Primary Outcome Measure

pCR [ Time Frame: after neoadjuvant treatment, at surgery ]

Central Contacts

Related Studies