Clinical trial · Interventional
Doxorubicin HCI Liposome Injection Versus Weekly Docetaxel in Patients First Relapse Metastatic Breast Cancer
A Phase II Randomized Crossover Study Doxorubicin HCI Liposome Injection Versus Weekly Docetaxel in Patients First Relapse Metastatic Breast Cancer
NCT00193037CI-TRIAL-00011516completedPhase 2Results postedClinicalTrials.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)
The efficacy of single agent liposomal doxorubicin as compared to single agent docetaxel will be evaluated as first line treatment in metastatic breast cancer patients, with subsequent crossover to the opposite arm at disease progression or patient intolerance. We will explore this as well as any possible cross resistance between these two agents.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| Liposomal Doxorubicin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Liposomal Doxorubicin
- description
- Liposomal doxorubicin 40 mg/m2 by 1 hour IV infusion repeated every 28 days.
- interventionNames
- Drug: Liposomal Doxorubicin
- type
- EXPERIMENTAL
- label
- Docetaxel
- description
- Weekly docetaxel 36 mg/m2 by 30 minute IV infusion on days 1, 8, and 15 of the 28 day cycle
- interventionNames
- Drug: Docetaxel
Primary outcomes (1)
- measure
- Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: To be included in this study, you must meet the following criteria: * Metastatic breast cancer confirmed by biopsy * Prior adjuvant/neoadjuvant treatment allowed * Measurable disease * Able to perform activities of daily living with minimal assistance * Age 18 years or older * Adequate bone marrow, liver and kidney function * Normal heart function * Written informed consent Exclusion Criteria: You cannot participate in this study if any of the following apply to you: * Pre-existing moderate peripheral neuropathy * History of significant heart disease * Meningeal metastases. * Prior chemotherapy for metastatic breast cancer * No measurable disease (including bone only, pleural effusions, etc.) * Receiving Herceptin therapy. * Women who are pregnant or lactating. Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
References
Publications (1)
- RESULTYardley DA, Burris HA 3rd, Spigel DR, Clark BL, Vazquez E, Shipley D, Barton J, Thompson D, Montes I, Greco FA, Hainsworth JD. A phase II randomized crossover study of liposomal doxorubicin versus weekly docetaxel in the first-line treatment of women with metastatic breast cancer. Clin Breast Cancer. 2009 Nov;9(4):247-52. doi: 10.3816/CBC.2009.n.042. PMID 19933081