CPG 7909 Plus Herceptin® In Patients With Metastatic Breast Cancer

NCT00043394

Last updated date
Study Location
Pfizer Investigational Site
Berkely, California, 94704, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Carcinoma
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Histologically confirmed breast cancer with metastases

- Tumor that has overexpression of HER2 as documented by being either FISH-positive or HER2/neu 3+ confirmed by immunohistochemistry

- Patients may have had up to three prior chemotherapy regimens for metastatic disease, which may have been given in combination with Herceptin® and which may have been discontinued due to toxicities. In addition, patients may have had adjuvant chemotherapy.

- Phase II only: Must have measurable disease by RECIST criteria (defined in section 8) with at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with conventional techniques, or as > 10 mm with spiral CT scan

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Any prior therapy with anthracycline + Herceptin® concurrently


- Significant cardiovascular disease (e.g., NYHA class 3 congestive heart failure,
myocardial infarction within the past 6 months, unstable angina; coronary angioplasty
within the past 6 months, uncontrolled atrial or ventricular cardiac arrhythmias) or
left ventricular ejection fraction < 50%


- Pre-existing autoimmune or antibody-mediated diseases including but not limited to:
systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's
syndrome, autoimmune thrombocytopenia

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Breast CarcinomaCPG 7909 Plus Herceptin® In Patients With Metastatic Breast Cancer
NCT00043394
  1. Berkely, California
  2. Orange, California
  3. Palm Springs, California
  4. New Haven, Connecticut
  5. Washington, District of Columbia
  6. Plantation, Florida
  7. Ann Arbor, Michigan
  8. Dearborn, Michigan
  9. Detroit, Michigan
  10. West Bloomfield, Michigan
  11. Cleveland, Ohio
  12. Burlington, Vermont
Female
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE CPG 7909 Plus Herceptin® In Patients With Metastatic Breast Cancer
Official Title  ICMJE A Phase I/II Open Label, Multi-Center, Dose-Escalation Study Of Subcutaneous CPG 7909 Plus Herceptin® In Patients With Metastatic Breast Cancer
Brief Summary To determine the safety and efficacy of CPG 7909 Injection given with Herceptin to patients with metastatic breast cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Breast
Intervention  ICMJE
  • Drug: 0.04 mg/kg CpG 7909
    0.04 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks
    Other Name: PF-03512676, ProMune
  • Drug: Herceptin®
    Herceptin® (maintenance dose per the manufacturer's directions) followed by a subcutaneous injection of CpG 7909.
    Other Name: Trastuzumab
  • Drug: 0.08 mg/kg CpG 7909
    0.08 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks
    Other Name: PF-03512676, ProMune
  • Drug: 0.12 mg/kg CpG 7909
    0.12 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks
    Other Name: PF-03512676, ProMune
  • Drug: 0.16 mg/kg CpG 7909
    0.16 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks
    Other Name: PF-03512676, ProMune
Study Arms  ICMJE
  • Experimental: Cohort 1
    0.04 mg/kg CpG 7909
    Interventions:
    • Drug: 0.04 mg/kg CpG 7909
    • Drug: Herceptin®
  • Experimental: Cohort 2
    0.08 mg/kg CpG 7909
    Interventions:
    • Drug: 0.08 mg/kg CpG 7909
    • Drug: Herceptin®
  • Experimental: Cohort 3
    0.12 mg/kg CpG 7909 Injection once weekly
    Interventions:
    • Drug: 0.12 mg/kg CpG 7909
    • Drug: Herceptin®
  • Experimental: Cohort 4
    0.16 mg/kg CpG 7909
    Interventions:
    • Drug: 0.16 mg/kg CpG 7909
    • Drug: Herceptin®
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 11, 2009)
16
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
64
Actual Study Completion Date  ICMJE October 2003
Actual Primary Completion Date October 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically confirmed breast cancer with metastases
  • Tumor that has overexpression of HER2 as documented by being either FISH-positive or HER2/neu 3+ confirmed by immunohistochemistry
  • Patients may have had up to three prior chemotherapy regimens for metastatic disease, which may have been given in combination with Herceptin® and which may have been discontinued due to toxicities. In addition, patients may have had adjuvant chemotherapy.
  • Phase II only: Must have measurable disease by RECIST criteria (defined in section 8) with at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with conventional techniques, or as > 10 mm with spiral CT scan

Exclusion Criteria:

  • Any prior therapy with anthracycline + Herceptin® concurrently
  • Significant cardiovascular disease (e.g., NYHA class 3 congestive heart failure, myocardial infarction within the past 6 months, unstable angina; coronary angioplasty within the past 6 months, uncontrolled atrial or ventricular cardiac arrhythmias) or left ventricular ejection fraction < 50%
  • Pre-existing autoimmune or antibody-mediated diseases including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, autoimmune thrombocytopenia
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00043394
Other Study ID Numbers  ICMJE C015
A8501021, CO15
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP