Clinical trial · Interventional
Weekly Paclitaxel and Trastuzumab in Metastatic Breast Cancer
Weekly Application of Trastuzumab and Paclitaxel in the Treatment of 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 3 weekly combination of trastuzumab and paclitaxel has been approved for the treatment of advanced breast cancer based on a large pivotal study. However, mono and combination chemotherapy trials suggest that weekly paclitaxel has a better therapeutic index, especially in the palliative setting. The present trial examines the efficacy and safety of weekly paclitaxel over a limited duration combined with continued trastuzumab in HER2+ patients.
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 |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| paclitaxel plus trastuzumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- paclitaxel/trastuzumab
- description
- Single experimental arm in a phase II trial
- interventionNames
- Drug: paclitaxel plus trastuzumab
Primary outcomes (1)
- measure
- Progression-free survival
- timeFrame
- Patient follow-up on average for 15 months and up to a maximum of 51 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * histologically confirmed metastatic breast cancer overexpressing HER2 * pretreatment with anthracycline in either the adjuvant or palliative setting. * HER2 positivity was defined as 2+ or 3+ overexpression using the DAKO HercepTest, confirmed by fluorescence in-situ hybridization (FISH) if 2+. * informed consent Exclusion Criteria: * more than 1 chemotherapy for advanced disease * taxane or trastuzumab pretreatment * brain metastases * Eastern Cooperative Oncology Group (ECOG) performance status \>1 * pregnancy or lactation, childbearing potential without reliable contraception * clinically significant cardiac disease, * neutrophils \<1500/µl, platelets \<75,000/µl * total bilirubin and creatinine \>1.5 × the upper limit of normal
References
Publications (0)
Data not yet available