Clinical trial · Interventional
PS-341 in Treating Women With Metastatic Breast Cancer
Phase II Trial Of PS-341 In Metastatic Breast Cancer
NCT00025584CI-TRIAL-00009041completedPhase 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)
PS-341 may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth. Phase II trial to study the effectiveness of PS-341 in treating women who have metastatic breast cancer
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bortezomib | Drug | Bortezomib | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (bortezomib)
- description
- Patients receive PS-341 IV over 3-5 seconds twice weekly on weeks 1 and 2. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: bortezomib
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Objective tumor response (CR + PR)
- timeFrame
- Up to 24 months
- description
- The agent would be of definite interest for further investigation if the associated response rate is at least 30% (p1), and would not be of further interest if the response rate is below 10% (p0).
Secondary outcomes (4)
- measure
- Time to progression
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed invasive breast cancer * Clinical and/or radiological evidence of stage IV disease * Relapsed or resistant disease within 6-12 months after completion of prior chemotherapy with doxorubicin or epirubicin and/or paclitaxel or docetaxel foradvanced disease or in the adjuvant setting * At least 1 unidimensionally measurable lesion * At least 20 mm by conventional techniques * At least 10 mm by spiral CT scan * No bone metastases as only measurable site * Pleural or peritoneal effusions not acceptable as measurable disease * No known brain metastases * Hormone receptor status: * Estrogen receptor-negative * Estrogen receptor-positive * Female * Performance status - ECOG 0-2 * Performance status - Karnofsky 60-100% * More than 12 weeks * WBC at least 3,000/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Bilirubin normal * AST or ALT no greater than 2.5 times upper limit of normal * Creatinine normal * Creatinine clearance at least 60 mL/min * No acute ischemia or significant conduction abnormality by EKG * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia * LVEF greater than 50% * No uncontrolled concurrent illness * No psychiatric illness or social situation that would preclude study * No ongoing or active infection * No prior allergic reaction(s) to compounds of similar chemical or biologic composition to PS-341 * No other malignancy within the past 5 years except carcinoma in situ of the cervix or basal cell skin cancer * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier-method contraception * See Chemotherapy * See Disease Characteristics * No more than 1 prior chemotherapy regimen for metastatic disease * High-dose regimen or bone marrow transplantation considered 1 prior regimen * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered * Prior hormonal therapy for metastatic disease or in adjuvant setting allowed * Prior localized radiotherapy allowed if it does not influence the signal evaluable lesion * At least 4 weeks since prior radiotherapy and recovered * At least 2 weeks since prior minor surgery and recovered * At least 4 weeks since prior major surgery and recovered * No other concurrent investigational agent * No other concurrent investigational or commercial agents or therapies to treat this malignancy
References
Publications (0)
Data not yet available
No reference posted for this study.