Trastuzumab Rezetecan vs Trastuzumab Deruxtecan in the Neoadjuvant Treatment of HER2 Positive Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Trastuzumab rezetecan, Trastuzumab deruxtecan.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized, Open-Label, Phase II Study Comparing the Efficacy and Safety of Trastuzumab-rezetecan and Trastuzumab Deruxtecan (T-DXd) in Neoadjuvant Treatment of Patients With HER2-Positive Early or Locally Advanced Breast Cancer
Overview
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.
Interventions
- Drug Trastuzumab rezetecan
Participants will receive Trastuzumab-rezetecan for 8 cycles - Drug Trastuzumab deruxtecan
Participants will receive Trastuzumab deruxtecan for 8 cycles
Primary outcome measures
- Pathological Complete Response Rate [Time frame: 3 to 8 weeks after neoadjuvant treatment completion]
Secondary outcome measures (6)
- 3-Year Event-Free Survival (EFS) Rate [Time frame: 3 years after randomization]
- Objective Response Rate (ORR) [Time frame: Within 6 months after randomization]
- Event-Free Survival (EFS) [Time frame: 5-10 years]
- EORTC QLQ-C30 [Time frame: Within 1 year after randomization]
- QLQ-BR23 [Time frame: within 1 year after randomization]
- Adverse enents [Time frame: First dose to 30 days after last dose]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07416253 · HELEN-026 ADC