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

NCT07393425 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-02-06

No results posted yet for this study

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.

Conditions

  • HER2 + Breast Cancer

Interventions

DRUG

Trastuzumab Deruxtecan

4.8mg/kg, d1, q3w

DRUG

Pertuzumab

840mg on cycle1, 420mg on following cycles, d1, q3w

DRUG

Taxane Chemotherapy

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

DRUG

Trastuzumab (or biosimilar)

Trastuzumab 8mg/kg (loading dose) or 6mg/kg on following cycles, d1, q3w

DRUG

Pyrotinib 320mg

320mg qd

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    collaborator INDUSTRY

  • Shanghai Jiao Tong University School of Medicine

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-02
Primary Completion
2027-09-30
Completion
2032-09-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07393425 on ClinicalTrials.gov