Clinical trial · Interventional
Maintenance Chemotherapy in Metastatic Breast Cancer
Maintenance Paclitaxel Vs Control After Anthracycline/Paclitaxel Combined First-Line Chemotherapy in Metastatic Breast Cancer
NCT00289263CI-TRIAL-00000278unknownPhase 3ClinicalTrials.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)
This is a randomized, prospective and multicenter phase III study. Two-hundred-sixty-two (262) patients on each arm will be recruited in the study.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Time to disease progression with maintenance paclitaxel versus observation
Secondary outcomes (4)
- measure
- Overall survival
- measure
- Toxicity
- measure
- Quality of live
- measure
- Conversion to a better response
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent. * Patients with metastatic breast cancer in response or stable disease after six to eight courses of first line induction chemotherapy treatment * Measurable and/or evaluable disease * Performance status ECOG 0, 1, 2. * Normal cardiac function, confirmed by left ventricular ejection fraction (LVEF). Exclusion Criteria: * Presence of peripheral neuropathy \> grade 2 by NCI Common Toxicity Criteria (NCI-CTC) following induction chemotherapy * Adjuvant taxane-based therapy
References
Publications (0)
Data not yet available
No reference posted for this study.