Clinical trial · Interventional
Trastuzumab in Combination With Vinorelbine or Taxane-Based Chemotherapy in Patients With Metastatic Breast Cancer
A Randomized Phase III Study of Trastuzumab (Herceptin) in Combination With Either Vinorelbine (Navelbine), or Taxane-based Chemotherapy in Patients With HER2 Overexpressing Metastatic 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)
The purpose of this study is to compare two different combinations of chemotherapy with trastuzumab as initial treatment for HER2 positive advanced breast cancer. Half of the patients will receive trastuzumab in combination with a taxane form of chemotherapy (either paclitaxel or docetaxel), while the other group will receive trastuzumab in combination with vinorelbine.
Conditions
Conditions (2)
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 |
| Stage IV Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Trastuzumab | Drug | Trastuzumab | ALIAS |
| Vinorelbine | Drug | Vinorelbine | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To compare the overall response rate for patients receiving trastuzumab in combination with either vinorelbine or taxane-based chemotherapy.
Secondary outcomes (3)
- measure
- Characterization of the time to disease progression and time to treatment failure for patients receiving trastuzumab with either vinorelbine or taxane-based chemotherapy
- measure
- Characterization of side effects for both treatments
- measure
- analysis of quality of life for patients receiving either treatment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed invasive breast cancer, with stage IV disease * Tumors must be HER2 overexpressing * Measurable disease, defined as a least one lesion that can be accurately measured in at least one dimension * 18 years of age or older * Life expectancy of greater than 6 months * ECOG performance status of 0-2 * ANC count \> 1,500/mm3 * Platelets \> 100,000/mm3 * Total bilirubin \< 1.5 mg/dl * AST/ALT \< 115 U/I * Creatinine \< 2.0 mg/dl * Glucose \< 200 mg/dl * LVEF \> 50% Exclusion Criteria: * Prior chemotherapy or prior trastuzumab therapy for metastatic breast cancer * Concurrent hormonal therapy, chemotherapy, or radiation treatments * Pregnant or lactating women * Known brain metastases or leptomeningeal carcinomatosis * History of grade 3 or 4 allergic reactions attributed to compounds of similar chemical or biologic composition to the agents in this study * Pre-existing neuropathy from any cause in excess of grade 1 * Uncontrolled intercurrent illness * History of other non-breast cancer malignancy except for carcinoma in situ of the cervix or non-melanoma skin cancer * Patients taking macrolide antibiotics, ketoconazole, or AZT
References
Publications (0)
Data not yet available