Trastuzumab Rezetecan vs Trastuzumab Deruxtecan in the Ne... | NCT07416253

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

NCT07416253

Sponsor

Henan Cancer Hospital

Status

Not yet recruiting

Last Update Posted

Feb 18, 2026Actual

Enrollment

68Estimated

Phase

Phase 2

Conditions

Breast Cancer

Interventions

Trastuzumab rezetecan
Trastuzumab deruxtecan

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2026Estimated

Primary Completion Date

Mar 2027Estimated

Completion Date

Jul 2030Estimated

First Submitted Date

Feb 10, 2026

First Submission Date that Met QC Criteria

Feb 10, 2026

First Posted Date

Feb 18, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 10, 2026

Last Update Posted Date

Feb 18, 2026Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

68Estimated

Label	Type	Description	Intervention Names
trastuzumab-rezetecan group	Experimental		Drug: Trastuzumab rezetecan
trastuzumab deruxtecan group	Active Comparator		Drug: Trastuzumab deruxtecan

Name	Type	Description	Arm Group Labels	Other Names
Trastuzumab rezetecan	Drug	Participants will receive Trastuzumab-rezetecan for 8 cycles	trastuzumab-rezetecan group

Measure	Description	Time Frame
Pathological Complete Response Rate		3 to 8 weeks after neoadjuvant treatment completion

Measure	Description	Time Frame
3-Year Event-Free Survival (EFS) Rate		3 years after randomization
Objective Response Rate (ORR)		Within 6 months after randomization
Event-Free Survival (EFS)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases