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PS-341 in Treating Women With Metastatic Breast Cancer

Phase II Trial Of PS-341 In Metastatic Breast Cancer

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00025584
Enrollment
35
Registered
2003-01-27
Start date
2001-08-31
Completion date
Unknown
Last updated
2013-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Breast Cancer, Stage IV Breast Cancer

Brief summary

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

Detailed description

PRIMARY OBJECTIVES: I. Determine the efficacy of PS-341, in terms of response rate, in women with metastatic breast cancer. SECONDARY OBJECTIVES: I. Determine the clinical activity of this drug, in terms of progression-free survival, in these women. II. Determine the toxicity profile and tolerability of this drug in these women. III. Determine the pharmacodynamics of this drug in these women. OUTLINE: 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. PROJECTED ACCRUAL: A maximum of 12-35 patients will be accrued for this study within 9-12 months.

Interventions

DRUGbortezomib

Given IV

OTHERlaboratory biomarker analysis

Correlative studies

Sponsors

National Cancer Institute (NCI)
Lead SponsorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Objective tumor response (CR + PR)Up to 24 monthsThe 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

MeasureTime frameDescription
Time to progressionUp to 3 yearsWill be reported using the Kaplan-Meier method with 95% confidence intervals indicated.
Overall survivalUp to 3 yearsWill be reported using the Kaplan-Meier method with 95% confidence intervals indicated.
Correlation between variations in the serum levels of adhesion molecules and angiogenic factorsUp to 24 monthsWill be evaluated and descriptive analysis will be performed.
Tissue markers of biological activityUp to 24 monthsWill be described in case of lesions amenable to tissue biopsy. The plasma pharmacodynamics of PS-341 as measured by the 20S-proteosome assay, will be used to measured the biological activity of the drug and correlated with response to treatment and variations in biomarkers.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026