Clinical trial · Interventional
Phase II Trial of Bortezomib and Doxorubicin in Metastatic Breast Cancer
A Phase II Trial of Bortezomib and Doxorubicin in Metastatic Breast Cancer
NCT00574236CI-TRIAL-00042254terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): no additional funding
Summary
Brief summary (as posted)
Primary objective is to determine the effectiveness of the combination of bortezomib and doxorubicin in patients with metastatic breast cancer. The trial format is a single arm Phase II design wherein patients are treated with bortezomib IV on days 1, 4, 8, and 11 and with doxorubicin IV on days 1 and 8 of a 21-day cycle.
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 |
|---|---|---|---|
| PS-341, doxorubicin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A
- interventionNames
- Drug: PS-341, doxorubicin
Primary outcomes (1)
- measure
- Overall Response Rate
- timeFrame
- Every two cycles/42 days, up to 7 months
- description
- Determine the clinical efficacy of bortezomib and doxorubicin in patients with metastatic breast cancer. Overall response rate is defined as both complete and partial response per RECIST, where complete response is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10mm. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm.
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Cytologically or histologically confirmed metastatic breast cancer * Measurable or evaluable disease * Age \> 18, PS 0,1,2 * MUGA \> 45% * Received one or fewer chemotherapies or investigational regimens for metastatic disease, no limit to the number of prior hormonal therapies. May have had single agent Herceptin and/or Herceptin plus single-agent chemotx. * Must meet designated laboratory criteria within 14 days of enrollment Exclusion Criteria: * Doxorubicin for metatstatic disease. * Pregnant or lactating. * Active infections, no myocardial infarction within 2 months of enrollment. * Investigational drugs within 14 days of enrollment. * Chemotherapy, radiotherapy, hormonal therapy or other investigational therapy within 4 weeks of enrollment. * Neuropathy that is \> grade 2. * Active brain mets. * Hypersensitivity to bortezomib, boron, or mannitol.
References
Publications (0)
Data not yet available
No reference posted for this study.