NCT07416253

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for phase_2 breast-cancer

Timeline
50mo left

Started Mar 2026

Typical duration for phase_2 breast-cancer

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress5%
Mar 2026Jul 2030

First Submitted

Initial submission to the registry

February 10, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 18, 2026

Completed
11 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2030

Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

1 year

First QC Date

February 10, 2026

Last Update Submit

February 10, 2026

Conditions

Breast Cancer

Keywords

HER2 positiveAntibody-drug conjugate

Outcome Measures

Primary Outcomes (1)

  • Pathological Complete Response Rate

    3 to 8 weeks after neoadjuvant treatment completion

Secondary Outcomes (6)

  • 3-Year Event-Free Survival (EFS) Rate

    3 years after randomization

  • Objective Response Rate (ORR)

    Within 6 months after randomization

  • Event-Free Survival (EFS)

    5-10 years

  • EORTC QLQ-C30

    Within 1 year after randomization

  • QLQ-BR23

    within 1 year after randomization

  • +1 more secondary outcomes

Study Arms (2)

trastuzumab-rezetecan group

EXPERIMENTAL
Drug: Trastuzumab rezetecan

trastuzumab deruxtecan group

ACTIVE COMPARATOR
Drug: Trastuzumab deruxtecan

Interventions

Trastuzumab rezetecanDRUG

Participants will receive Trastuzumab-rezetecan for 8 cycles

trastuzumab-rezetecan group
Trastuzumab deruxtecanDRUG

Participants will receive Trastuzumab deruxtecan for 8 cycles

trastuzumab deruxtecan group

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Interventions

trastuzumab deruxtecan

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Zhenzhen Liu

CONTACT

13603862755zlyyliuzhenzhen0800@zzu.edu.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 10, 2026

First Posted

February 18, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

July 1, 2030

Last Updated

February 18, 2026

Record last verified: 2026-02