PS-341 in Treating Women With Metastatic Breast Cancer

• Status: Completed
• Trial end date: 2003-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwestern University
• Collaborator: National Cancer Institute (NCI)
• Treatments: Bortezomib; Proteasome Inhibitors

Criteria

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