PS-341 in Treating Women With Metastatic Breast Cancer

Northwestern University

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: bortezomib

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00028639

NCI 00B11

NCI-1862

NU-NCI00B11

Details and patient eligibility

About

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.

Full description

OBJECTIVES:

• Determine the objective tumor response in women with metastatic breast cancer treated with bortezomib.
• Determine the toxic effects of this drug in these patients.
• Determine the progression-free survival in patients treated with this drug.

OUTLINE: Patients receive bortezomib IV over 3-5 seconds twice weekly for 2 weeks. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 12-35 patients will be accrued for this study within 6-24 months.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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