PS-341 in Combination With Herceptin in Advanced Breast Cancer That Overexpresses HER-2

NCT00199212 | Completed Phase 1

• 1 other identifier: Herceptin-proteasome inhibitor
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this study is to determine the feasibility of the combination of the proteasome inhibitor bortezomib (PS-341, Velcade) with trastuzumab (Herceptin) and to determine the best dose of bortezomib to combine with two trastuzumab schedules, weekly and 3-weekly.

Conditions

Carcinoma Breast Stage IV

Keywords

HER-2 positive; metastatic breast cancer patients

Outcome Measures

Primary Outcomes (2)

• Feasibility and maximum tolerated dose

  Combination of Velcade and Herceptine in breast metastatic patients

  before recurrence

• Time of recurrence

  safety and tolerability of combinaison before recurrence of metastatic breast cance

  time of recurrence

Secondary Outcomes (1)

• Response rate

  time before response rate

Interventions

Combination of trastuzumab and PS-341 DRUG

Trastuzumab and velcade are used according standard procedure

Also known as: PS-341, velcade, trastuzumab, herceptine

Eligibility Criteria

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

You may qualify if:

• Female gender
• Age \>= 18 years
• ECOG performance status \< 2
• Histologically proven diagnosis of breast cancer
• Locally advanced and/or metastatic disease
• Life expectancy of three months or longer
• No concurrent second malignancy (except for adequately treated basal cell carcinoma of the skin, in situ carcinoma of the cervix or contralateral breast cancer). Any prior second malignancy must be in remission for \>= 5 years (except for contralateral breast cancer).
• No other serious illness or medical condition including:
• History of documented congestive heart failure; angina pectoris requiring antianginal medication; evidence of recent (\< 6 months) transmural infarction on electrocardiogram (ECG); poorly controlled hypertension (e.g. systolic \> 180 mmHg or diastolic greater than 100 mmHg); clinically significant valvular heart disease; or high-risk uncontrolled arrhythmias.
• Chronic lung disease
• History of significant neurological or psychiatric disorders that would prohibit the understanding and giving of informed consent, including psychotic disorders, mental retardation, and dementia.
• Active concurrent infection
• No symptomatic central nervous system (CNS) metastases
• No rapidly progressive visceral metastases requiring immediate chemotherapy
• No concurrent anti-cancer treatment is allowed.

Sponsors & Collaborators

• Jules Bordet Institute: lead

Study Sites (1)

Jules Bordet Institute

Brussels, 1000, Belgium

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Bortezomib; Trastuzumab

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; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Fatima Cardoso, MD

  Jules Bordet Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: October 1, 2003
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: February 24, 2011

Record last verified: 2011-02

Locations

BE (1)