Clinical trial · Interventional
PS-341 in Treating Women With Metastatic Breast Cancer
A Phase II Study of the Proteasome Inhibitor PS-341 (NSC 681 239) in Patients With Metastatic Breast Cancer
NCT00028639CI-TRIAL-00005298completedPhase 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)
RATIONALE: PS-341 may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth. PURPOSE: Phase II trial to study the effectiveness of PS-341 in treating women who have 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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bortezomib | Drug | Bortezomib | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the breast * Metastatic disease * At least 1 unidimensionally measurable lesion * At least 20 mm by conventional techniques OR * At least 10 mm by spiral CT scan * Previously treated with 1 prior chemotherapy regimen (with or without trastuzumab \[Herceptin\]) for metastatic disease * Relapse during or within 6 months after completion of adjuvant chemotherapy considered treatment failure * No known brain metastases * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 18 and over Sex: * Female Menopausal status: * Not specified Performance status: * ECOG 0-2 Life expectancy: * More than 3 months Hematopoietic: * WBC at least 3,000/mm\^3 * Absolute neutrophil count greater than 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin normal * SGOT/SGPT no greater than 2.5 times upper limit of normal Renal: * Creatinine normal OR * Creatinine clearance at least 60 mL/min Cardiovascular: * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia Other: * No uncontrolled concurrent illness * No ongoing or active infection * No psychiatric illness or social situation that would preclude study * No prior allergic reaction attributed to compounds of similar chemical or biological composition to bortezomib * No other prior malignancy within the past 5 years unless curatively treated and disease free * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics Chemotherapy: * See Disease Characteristics * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered Endocrine therapy: * Prior hormonal therapy for metastatic disease allowed * At least 4 weeks since prior hormonal therapy and recovered Radiotherapy: * At least 4 weeks since prior radiotherapy and recovered Surgery: * Not specified Other: * Prior adjuvant therapy allowed * At least 4 weeks since prior investigational drugs and recovered * No other concurrent investigational or commercial agents or therapies for breast cancer * No concurrent combination antiretroviral therapy for HIV
References
Publications (0)
Data not yet available
No reference posted for this study.