Clinical trial · Interventional

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

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

NCT07416253CI-TRIAL-00103573not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Breast Cancer	Malignant Breast Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
Trastuzumab deruxtecan	Drug	—	UNRESOLVED
Trastuzumab rezetecan	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
trastuzumab-rezetecan group
interventionNames
1. Drug: Trastuzumab rezetecan
type
ACTIVE_COMPARATOR
label
trastuzumab deruxtecan group
interventionNames
1. Drug: Trastuzumab deruxtecan

Primary outcomes (1)

measure
Pathological Complete Response Rate
timeFrame
3 to 8 weeks after neoadjuvant treatment completion

Secondary outcomes (6)

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

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 18 Years
Maximum age: 75 Years

Show eligibility criteria text

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.

References

Publications (0)

Data not yet available

No reference posted for this study.