Clinical trial · Interventional
Liposomal Doxorubicin and Docetaxel in Metastatic Breast Cancer
A Multi-center Phase II Study Evaluating the Efficacy and Tolerance of the Association of Liposomal Doxorubicin and Docetaxel in First Line Chemotherapy in Patients With Metastatic Breast Cancer
NCT00524810CI-TRIAL-00005135completedPhase 2ClinicalTrials.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)
Evaluation of safety and efficacy of a treatment associating Pegylated Liposomal Doxorubicin + Docetaxel in patients with metastatic breast cancer
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 |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| Pegylated liposomal doxorubicin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Caelyx - Taxotere
- interventionNames
- Drug: Pegylated liposomal doxorubicin
- Drug: Docetaxel
Primary outcomes (1)
- measure
- Non-progression rate after 6 cycles
- timeFrame
- 6 months
Secondary outcomes (4)
- measure
- tolerance and toxicity
- timeFrame
- 6 months
- measure
- Tumor response and duration
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * first metastatic chemo line * presence of measurable or bone lesion * at least one lesion outside the radiated areas * can have previously received hormonotherapy, chemotherapy in adjuvant phase, radiotherapy if older than 4 weeks Exclusion Criteria: * only local tumoral progression * symptomatic cerebral metastasis * neuropathy \> NCI-CTC 2 * previous cancer within 10 years \_ previous cancer within 10 years
References
Publications (0)
Data not yet available
No reference posted for this study.