Safety Study of Combined Immunotherapy With Trastuzumab and Cetuximab in Patients With Metastatic Breast Cancer

Back to results

Primary Purpose

Status

Unknown status

Phase

Phase 1

Locations

Austria

Study Type

Interventional

Intervention

Cetuximab

Trastuzumab

About this trial

This is an interventional treatment trial for Metastatic Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: diagnosis of metastatic breast cancer presence of at least 1 measurable lesion according to modified RECIST criteria Evidence (fluorescence in situ hybridization FISH) of Her-2 overexpression in tumor tissue:Group A: Her-2 +++, Group B: Her-2 + or ++ EGFR-expressing disease as assessed by immunohistochemistry Recovered from relevant toxicities from other treatment prior to study entry Exclusion Criteria: Prior treatment with trastuzumab for metastatic breast cancer (adjuvant therapy is allowed) Prior treatment with cetuximab Concomitant cytotoxic chemotherapy Treatment with any investigational agent(s) within 4 weeks prior to study entry Known allergic/hypersensitivity reaction to any of the components of study treatments severe dyspnea Myocardial infarction within 6 months prior to study entry, uncontrolled congestive heart failure; or any current grade 3 or 4 cardio-vascular disorder despite treatment History of significant neurologic or psychiatric disorders

Sites / Locations

Dept of Internal MedicineRecruiting

Outcomes

Primary Outcome Measures

Pharmacokinetics and drug/drug interaction of cetuximab and

Secondary Outcome Measures

Safety and tolerability of the combination treatment

Response

Full Information

NCT ID

NCT00367250

First Posted

August 21, 2006

Last Updated

September 27, 2010

Sponsor

Medical University of Vienna

1. Study Identification

Unique Protocol Identification Number

NCT00367250

Brief Title

Safety Study of Combined Immunotherapy With Trastuzumab and Cetuximab in Patients With Metastatic Breast Cancer

Official Title

Phase I Study Investigating the Combined Immunotherapy With Trastuzumab and Cetuximab in Patients With Metastatic Breast Cancer With High and Moderate HER2 Expression

Study Type

Interventional

2. Study Status

Record Verification Date

September 2010

Overall Recruitment Status

Unknown status

Study Start Date

July 2006 (undefined)

Primary Completion Date

June 2011 (Anticipated)

Study Completion Date

June 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Medical University of Vienna

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

One important approach to change the natural history of advanced breast cancer is that of designing new combination chemotherapies in which the best drugs already available are used together with new anticancer agents devoid of clinical cross-resistance. The possibility of exploiting the combined use of cetuximab and trastuzumab represents an option of potential great impact on the probability of response and long-term therapeutic results for patients with advanced breast cancer and HER2 overexpression.Therefore, patients with tumors that demonstrate EGFR expression and clear-cut erbB-2 overexpression (3+) or limited erbB-2 overexpression (+ or 2+) will be included in the study. Patients will be treated with trastuzumab and cetuximab to study the pharmacokinetics and potential drug/drug interaction of both antibodies as well as the safety and tolerability of this novel combination treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Breast Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

32 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Cetuximab

Intervention Description

weekly i.v.

Intervention Type

Drug

Intervention Name(s)

Trastuzumab

Intervention Description

weekly i.v.

Primary Outcome Measure Information:

Title

Pharmacokinetics and drug/drug interaction of cetuximab and

Time Frame

repeated PK measurements week 1-13

Secondary Outcome Measure Information:

Title

Safety and tolerability of the combination treatment

Time Frame

week 1 -13

Title

Response

Time Frame

week 9 and 13

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: diagnosis of metastatic breast cancer presence of at least 1 measurable lesion according to modified RECIST criteria Evidence (fluorescence in situ hybridization FISH) of Her-2 overexpression in tumor tissue:Group A: Her-2 +++, Group B: Her-2 + or ++ EGFR-expressing disease as assessed by immunohistochemistry Recovered from relevant toxicities from other treatment prior to study entry Exclusion Criteria: Prior treatment with trastuzumab for metastatic breast cancer (adjuvant therapy is allowed) Prior treatment with cetuximab Concomitant cytotoxic chemotherapy Treatment with any investigational agent(s) within 4 weeks prior to study entry Known allergic/hypersensitivity reaction to any of the components of study treatments severe dyspnea Myocardial infarction within 6 months prior to study entry, uncontrolled congestive heart failure; or any current grade 3 or 4 cardio-vascular disorder despite treatment History of significant neurologic or psychiatric disorders

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Christoph Wiltschke, Prof

Phone

+43 40400 4445

Email

Christoph.Wiltschke@meduniwien.ac.at

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christoph Zielinski, MD

Organizational Affiliation

Dept of Internal Medicine, Medical University Vienna

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dept of Internal Medicine

City

Vienna

ZIP/Postal Code

1090

Country

Austria

Individual Site Status

Recruiting

12. IPD Sharing Statement

Links:

URL

http://www.meduniwien.ac.at/innere-med-1/onkologie/

Description

Dept of Oncology, Medical University Vienna

Metastatic Breast Cancer

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial