Trastuzumab Rezetecan vs Trastuzumab Deruxtecan in the Neoadjuvant Treatment of HER2 Positive Breast Cancer

Starting soon · Phase 2

Conditions studied: Breast Cancer

In brief

This is a single-center, randomized, open-label, phase II interventional study. Eligible patients will be randomized 1:1 to receive either Trastuzumab-rezetecan (4.8 mg/kg Q3W) or T-DXd (5.4 mg/kg Q3W) for 8 neoadjuvant cycles. After completing neoadjuvant treatment, patients will undergo definitive surgery, and tpCR will be assessed from resected specimens. Patients will then be followed up to monitor long-term efficacy (e.g., EFS) and late-onset adverse events. A total of 68 patients (34 per arm) will be enrolled to achieve the study's statistical objectives.

Key facts

Study ID

NCT07416253

Run by

Henan Cancer Hospital

People needed

68

Starts

2026-03-01

Expected to finish

2030-07-01

Last updated by the study team

2026-02-18

Who can join

Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female, 18-75 years old, treatment-naive
• ECOG PS 0-1
• Histologically confirmed HER2+ (IHC 3+ or IHC 2+/ISH+) early/locally advanced breast cancer (AJCC 8th: cT2-cT4 any N cM0) or cT1c N+ cM0; known ER/PR status
• Adequate organ function (hematology/biochemistry/coagulation/urine/cardiac)
• Negative pregnancy test (childbearing women); agree to effective contraception
• Sign an informed consent form.

You may not qualify if…

• Bbilateral/inflammatory/occult breast cancer.
• Prior anti-tumor therapy (chemotherapy/radiotherapy/targeted therapy, etc.); radical radiotherapy (4 weeks prior) or palliative radiotherapy (2 weeks prior) to first dose.
• Concurrent anti-tumor therapy; other malignancies (within past 5 years, except cured basal cell carcinoma/cervical CIS).
• Prior trial participation (past 4 weeks); systemic immunosuppressants/hormones (>10 mg/day prednisone equivalent, 2 weeks prior; nasal/inhaled steroids excluded).
• Live/attenuated vaccine (past 4 weeks); major non-breast surgery (4 weeks prior, incomplete recovery).
• Active/relapsing autoimmune disease (except controlled hypothyroidism/well-managed skin diseases/type 1 diabetes); immunodeficiency (HIV+/organ transplant).
• Uncontrolled cardiovascular/cerebrovascular disease (e.g., MI/stroke in 6 months, NYHA III-IV heart failure, QTcF >470 msec [female]).
• Active ILD/severe lung disease; active hepatitis B (HBsAg+ \& HBV DNA ≥500 IU/mL)/hepatitis C (HCV RNA+); severe infection requiring anti-infective therapy.
• Bleeding/thrombotic tendency; hypersensitivity to study drugs/excipients.
• Pregnant/lactating women; women of childbearing potential with positive pregnancy test or refusing contraception.
• Other conditions (e.g., uncontrolled hypertension/diabetes, neuropsychiatric disorders) deemed unsuitable by the investigator.

Full record on ClinicalTrials.gov

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