PS-341 in Treating Women With Metastatic Breast Cancer

NCT00025584 | Completed Phase 2

• 4 other identifiers: NCI-2012-02422ID00-308N01CM17003CDR0000068976
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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

Conditions

Recurrent Breast Cancer; Stage IV Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Objective tumor response (CR + PR)

  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).

  Up to 24 months

Secondary Outcomes (4)

• Time to progression

  Up to 3 years

• Overall survival

  Up to 3 years

• Correlation between variations in the serum levels of adhesion molecules and angiogenic factors

  Up to 24 months

• Tissue markers of biological activity

  Up to 24 months

Study Arms (1)

Treatment (bortezomib)

EXPERIMENTAL

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.

Drug: bortezomib; Other: laboratory biomarker analysis

Interventions

bortezomib DRUG

Given IV

Also known as: LDP 341, MLN341, VELCADE

Treatment (bortezomib)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (bortezomib)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Bortezomib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Massimo Cristofanilli

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2001
• First Posted: January 27, 2003
• Study Start: August 1, 2001
• Primary Completion: August 1, 2004
• Last Updated: January 23, 2013

Record last verified: 2013-01

Locations

US (1)