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Completed

NCT Number: NCT00043394

CPG 7909 Plus Herceptin® In Patients With Metastatic Breast Cancer

To determine the safety and efficacy of CPG 7909 Injection given with Herceptin to patients with metastatic breast cancer.

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Key information

Conditions

Carcinoma, Breast Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Pfizer Investigational Site, Berkely, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

0.04 mg/kg CpG 7909

Drug

0.04 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks

Other names: PF-03512676, ProMune

Herceptin®

Drug

Herceptin® (maintenance dose per the manufacturer's directions) followed by a subcutaneous injection of CpG 7909.

Other names: Trastuzumab

0.08 mg/kg CpG 7909

Drug

0.08 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks

Other names: PF-03512676, ProMune

0.12 mg/kg CpG 7909

Drug

0.12 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks

Other names: PF-03512676, ProMune

0.16 mg/kg CpG 7909

Drug

0.16 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks

Other names: PF-03512676, ProMune

Primary outcomes

  1. Phase I: To evaluate the safety and tolerability of several dose levels of CPG 7909 (up to a maximum of 0.16 mg/kg) and to determine the maximum tolerated dose (MTD)* of CPG 7909 in combination with Herceptin®

    Time frame: 24 weeks

  2. Phase II: To evaluate tumor response and safety of CPG 7909 (at the MTD as determined in Phase I) in combination with Herceptin® in patients with metastatic breast cancer.

    Time frame: 24 weeks

Secondary outcomes

  1. Phase I To evaluate tumor response, duration of response, time to disease progression, ECOG performance status, and survival time.

    Time frame: 24 weeks

  2. Phase II To evaluate duration of response, time to disease progression, ECOG performance status, and survival time.

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase I/II Open Label, Multi-Center, Dose-Escalation Study Of Subcutaneous CPG 7909 Plus Herceptin® In Patients With Metastatic Breast Cancer

Important dates

Study start
2002
Primary completion
2003
Study completion
2003
First posted
Aug 12, 2002
Registry last updated
Mar 12, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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