Clinical trial · Interventional
Trial to Compare the Safety, Efficacy and Immunogenicity of TX05 With Herceptin® in HER2+ Early Breast Cancer
A Randomized, Double-blind, Parallel Group, Phase III Trial to Compare the Efficacy, Safety, and Immunogenicity of TX05 With Herceptin® in Subjects With HER2 Positive Early Breast Cancer
NCT03556358CI-TRIAL-00055977completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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 is a Phase III, double-blind, randomized, multicenter study to compare the efficacy and to evaluate the safety and immunogenicity of TX05 (trastuzumab) with Herceptin® in subjects with HER2 positive early breast cancer.
Conditions
Conditions (5)
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 |
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| HER2-positive Breast Cancer | HER2-Positive Breast Carcinoma | ALIAS | 0.90 |
| Stage II Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIA Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Epirubicin | Drug | Epirubicin | ALIAS |
| Herceptin® | Biological | Trastuzumab | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| TX05 (trastuzumab) | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TX05 (trastuzumab)
- description
- • Intravenous (IV) epirubicin, 75 mg/m\^2 and cyclophosphamide 600 mg/m2 every 3 weeks for 4 cycles Followed by: • IV TX05 8 mg/kg loading dose then 6 mg/kg and paclitaxel 175 mg/m2 every 3 weeks for 4 cycles
- interventionNames
- Biological: TX05 (trastuzumab)
- Drug: Paclitaxel
- Drug: Epirubicin
- Drug: Cyclophosphamide
- type
- ACTIVE_COMPARATOR
- label
- Herceptin®
- description
- • Intravenous (IV) epirubicin, 75 mg/m\^2 and cyclophosphamide 600 mg/m2 every 3 weeks for 4 cycles Followed by: • IV Herceptin 8 mg/kg loading dose then 6 mg/kg and paclitaxel 175 mg/m2 every 3 weeks for 4 cycles
- interventionNames
- Biological: Herceptin®
- Drug: Paclitaxel
- Drug: Epirubicin
- Drug: Cyclophosphamide
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * Histologically confirmed HER 2 overexpressing invasive primary operable Stage II/IIIa breast cancer (AJCC version 7 staging criteria). * Available tumor tissue for central review of HER2 status. * Planned surgical resection of breast tumor. * Planned neoadjuvant chemotherapy. * Documentation of HER2 gene amplification or overexpression. * Ipsilateral, measurable tumor longest diameter \> 2 cm. * Known estrogen receptor (ER) and progesterone receptor (PR) hormone status (may be performed during screening). * ECOG performance status of 0 or 1. * Adequate bone marrow, hepatic and renal functions. * Left ventricular ejection fraction (LVEF) ≥ 50% or within institutional normal limits, measured by echocardiography or MUGA scan. * Effective contraception as defined by protocol. Key Exclusion Criteria: * Investigational therapy within 2 months of first dose of study drug. * Bilateral breast cancer. * Inflammatory breast cancer * Metastases. * Prior chemotherapy, biologic therapy, radiation or surgery for any active malignancy, including breast cancer. * Cardiac insufficiency, myocardial infarction, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident, unstable angina pectoris, uncontrolled arrhythmia or pulmonary embolus within the previous 12 months prior to 1st administration of study drug. * Clinically significant active infection, poorly controlled diabetes mellitus and/or uncontrolled hypertension. * Major surgery, significant traumatic injury, radiation therapy and/or grade 3 hemorrhage within 4 weeks of 1st administration of study drug. * Pre-existing clinically significant Grade 2 peripheral neuropathy. * Malignancy within the last 5 years (except squamous/basal cell carcinoma of the skin, cervical carcinoma in situ and superficial bladder cancer). * Severe dyspnea at rest requiring oxygen therapy. * Known positive HIV, acute or chronic active infection with Hepatitis B or Hepatitis C. * Current pregnancy or breastfeeding. * Pre-existing thyroid abnormality with thyroid function that cannot be maintained in normal range despite optimal therapy.
References
Publications (0)
Data not yet available
No reference posted for this study.