Clinical trial · Interventional
ctDNA in HER2+ EBC Neoadjuvant Treatment
A Randomized, Multicenter, Open-label Clinical Study Using Peripheral Blood Circulating Tumor DNA to Evaluate the Efficacy of Preoperative Treatment With Pyrotinib + Trastuzumab + Docetaxel Versus Pertuzumab + Trastuzumab + Docetaxel in Early or Locally Advanced HER2-positive Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is a randomized, open-label, multicenter clinical study for patients with early or locally advanced (T≥2cm, N0-3, M0) HER2-positive breast cancer, aiming to compare the peripheral blood ctDNA clearance of neoadjuvant pyrotinib + trastuzumab + docetaxel and pertuzumab + trastuzumab + docetaxel for one course and to evaluate the therapeutic effectiveness of four courses of neoadjuvant therapy
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel | Drug | Docetaxel | ALIAS |
| pertuzumab | Drug | Pertuzumab | ALIAS |
| pyrotinib | Drug | Pyrotinib | ALIAS |
| trastuzumab | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Pyrotinib-initiated arm
- description
- two cycles of docetaxel + trastuzumab + pyrotinib followed by two cycles of docetaxel + trastuzumab + pertuzumab
- interventionNames
- Drug: pyrotinib
- Drug: pertuzumab
- Drug: trastuzumab
- Drug: docetaxel
- type
- ACTIVE_COMPARATOR
- label
- Pertuzumab-initiated arm
- description
- four cycles of docetaxel + trastuzumab + pertuzumab
- interventionNames
- Drug: pertuzumab
- Drug: trastuzumab
- Drug: docetaxel
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * histologically diagnosed with Stage II-III HER2+ breast cancer (primary diameter \>2cm) * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Intact renal, hepatic, bone marrow and cardiac functions including baseline left ventricular ejection fraction (LVEF) ≥ 55% measured by echocardiography * No prior treatment Exclusion Criteria: * Bilateral or metastatic breast cancer * History of other malignancies * Severe cardiovascular disease * Allergic to any of the regimens
References
Publications (0)
Data not yet available