Clinical trial · Interventional
Therapy of Metastatic Breast Cancer With Paclitaxel and Liposomal Doxorubicin
Extended Dose Frequency 1st-line Therapy of Metastatic Breast Cancer With Paclitaxel and Liposomal Doxorubicin (Myocet®)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study was stopped due because recrutation.was much slower as anticipated.
Summary
Brief summary (as posted)
Today metastatic breast cancer is regarded as cureless. The treatment is palliative in intent and the goals of treatment include improvement of quality of life and if possible prolongation of life. Treatment in metastatic cancer will usually involve hormone therapy and/or chemotherapy. Weekly application of chemotherapeutical drugs may lead to less drug concentrations in healthy tissue and therefore toxicities maý be reduced.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| liposomal Doxorubicin | Drug | — | UNRESOLVED |
| Myocet / Paclitaxel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Myocet/Paclitaxel
- description
- 20 mg/m² Myocet® as 30-minutes infusion on day 1,8,15 80 mg/m² Paclitaxel as 60-minutes infusion on day 1,8,15 q21d
- interventionNames
- Drug: liposomal Doxorubicin
- Drug: Myocet / Paclitaxel
Primary outcomes (1)
- measure
- progression free survival assessed by imaging procedures
- timeFrame
- after 6 weeks, 12 weeks, 18 weeks
Secondary outcomes (2)
- measure
- toxicity, quality of life
- timeFrame
- every 3 weeks
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women \>/= 18 years with histologically proven metastatic breast cancer * No prior chemotherapy in the advanced situation * ECOG \</= 2 * Adequate bone marrow reserve * left ventricular ejection fraction (LVEF) \>/= 50, measured within 4 weeks before study treatment * Existence of written informed consent Exclusion Criteria: * Previous high dose therapy with stem cell support * Prior adjuvant treatment with cumulative anthracycline dose of 600 mg/m² Epirubicin, 300 mg/m² Doxorubicin, 80 mg/m² Mitoxantrone * Concomitant hormon- or chemotherapy or radiation therapy * Her2/neu overexpression * pregnancy or breast feeding
References
Publications (0)
Data not yet available