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Completed

NCT Number: NCT00031278

Safety And Efficacy Study Of The Combination Of CpG 7909 And Herceptin In Patients With Metastatic Breast Cancer

The purpose of this study is to determine if the combination of CPG 7909 and Herceptin is safe and effective in the treatment of metastatic breast cancer.

RATIONALE: There is preclinical data that supports the hypothesis that CPG 7909 may potentiate the action of Herceptin. This Phase I/II study is designed to evaluate the safety and efficacy of the combination treatment of CPG 7909 and Herceptin in patients with metastatic breast cancer who have previously been treated with Herceptin and chemotherapy.

SCHEDULE: Patients will receive CPG 7909 weekly for up to six months.

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Key information

Conditions

Carcinoma, Metastatic Breast Carcinoma Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Univ. of Connecticut Health Center, Farmington, Connecticut, United States

Loading trial locations.

About this study

Phase II part of study not initiated because the development plan modified the route of administration to subcutaneous injection.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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 must be candidates for single agent Herceptin treatment according to the Herceptin® label.

Exclusion criteria

  • Any prior therapy with anthracycline + Herceptin®.
  • 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%.

Treatment and study plan

CPG 7909

Drug

Each 0.01 mg/kg CPG 7909 treatment will consist of a monitored 2-hour infusion given once weekly until disease progression or a maximum of 24 weeks.

Other names: PF-3512676, ProMune

Herceptin®

Drug

Herceptin® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert

Other names: trastuzumab

Primary outcomes

  1. Phase I: To evaluate the safety, tolerability and and MTD of several dose levels of CPG 7909 of CPG 7909 in combination with the standard Herceptin® treatment in patients with metastatic breast cancer

  2. Phase II: Evaluate tumor response and safety of CPG 7909 in combination with Herceptin® in patients with metastatic breast cancer

Secondary outcomes

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

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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase I/II Open Label, Multi-Center Study For The Evaluation Of The Combination Of CpG 7909 And Herceptin® In Patients With Metastatic Breast Cancer

Important dates

Study start
2001
Primary completion
2003
Study completion
2003
First posted
Mar 1, 2002
Registry last updated
May 30, 2011

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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