Breast Cancer
Conditions
Keywords
HER2 positive, Antibody-drug conjugate
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.
Interventions
Participants will receive Trastuzumab-rezetecan for 8 cycles
DRUGTrastuzumab deruxtecan
Participants will receive Trastuzumab deruxtecan for 8 cycles
Sponsors
Henan Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Female, 18-75 years old, treatment-naive 2. ECOG PS 0-1 3. 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 4. Adequate organ function (hematology/biochemistry/coagulation/urine/cardiac) 5. Negative pregnancy test (childbearing women); agree to effective contraception 6. Sign an informed consent form.
Exclusion criteria
1. Bbilateral/inflammatory/occult breast cancer. 2. Prior anti-tumor therapy (chemotherapy/radiotherapy/targeted therapy, etc.); radical radiotherapy (4 weeks prior) or palliative radiotherapy (2 weeks prior) to first dose. 3. Concurrent anti-tumor therapy; other malignancies (within past 5 years, except cured basal cell carcinoma/cervical CIS). 4. Prior trial participation (past 4 weeks); systemic immunosuppressants/hormones (\>10 mg/day prednisone equivalent, 2 weeks prior; nasal/inhaled steroids excluded). 5. Live/attenuated vaccine (past 4 weeks); major non-breast surgery (4 weeks prior, incomplete recovery). 6. Active/relapsing autoimmune disease (except controlled hypothyroidism/well-managed skin diseases/type 1 diabetes); immunodeficiency (HIV+/organ transplant). 7. Uncontrolled cardiovascular/cerebrovascular disease (e.g., MI/stroke in 6 months, NYHA III-IV heart failure, QTcF \>470 msec \[female\]). 8. Active ILD/severe lung disease; active hepatitis B (HBsAg+ \& HBV DNA ≥500 IU/mL)/hepatitis C (HCV RNA+); severe infection requiring anti-infective therapy. 9. Bleeding/thrombotic tendency; hypersensitivity to study drugs/excipients. 10. Pregnant/lactating women; women of childbearing potential with positive pregnancy test or refusing contraception. 11. Other conditions (e.g., uncontrolled hypertension/diabetes, neuropsychiatric disorders) deemed unsuitable by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological Complete Response Rate | 3 to 8 weeks after neoadjuvant treatment completion |
Secondary
| Measure | 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) | 5-10 years |
| EORTC QLQ-C30 | Within 1 year after randomization |
| QLQ-BR23 | within 1 year after randomization |
| Adverse enents | First dose to 30 days after last dose |
Contacts
CONTACTZhenzhen Liu
Outcome results
None listed