Phase 3
Completed N=809
Trial to Compare the Safety, Efficacy and Immunogenicity of TX05 With Herceptin® in HER2+ Early Breast Cancer
Source: ClinicalTrials.gov NCT03556358 ↗Enrolled (actual)
809
Serious AEs
2.5%
Results posted
Jan 2022
Primary outcomePrimary: Proportion of Subjects in Each Treatment Arm Who Achieve Pathologic Complete Response (pCR) — 172; 185; 164; 153 participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Subjects in Each Treatment Arm Who Achieve Pathologic Complete Response (pCR) |
172; 185; 164; 153 | — |
| SECONDARY Objective Response Rate (ORR) |
332; 340 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03556358). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.