Carcinoma, Metastatic BreastPhase 1/2NCT00031278
Safety And Efficacy Study Of The Combination Of CpG 7909 And Herceptin In Patients With Metastatic Breast Cancer
A Phase 1/2 study testing CPG 7909 and Herceptin® in people with Carcinoma, Metastatic Breast, run by Pfizer at 8 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Carcinoma, Metastatic Breast
- What is being tested?
- CPG 7909 and Herceptin®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 8 sitesUnited States
- Study dates
- Oct 2001to Jun 2003
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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%.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Comprehensive Cancer Center, University of Michigan
Ann Arbor, Michigan, 48109
Greenebaum Cancer Center at Univ. of Maryland
Baltimore, Maryland, 21201
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Fletcher Allen Health Care
Burlington, Vermont, 05401
Univ. of Connecticut Health Center
Farmington, Connecticut, 06030
Cancer Center at Saint Barnabas Medical Center
Livingston, New Jersey, 07039
Univ. of Pittsburgh Cancer Institute, Magee Women's Hosp.
Pittsburgh, Pennsylvania, 15213
Cancer Research Network, Inc.
Plantation, Florida, 33324
About this study
Official 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
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.
Read the detailed description
Phase II part of study not initiated because the development plan modified the route of administration to subcutaneous injection.
- Conditions
- Carcinoma, Metastatic Breast
- Being tested
- CPG 7909, Herceptin®
- Keywords
- Metastatic, Breast, Cancer, immunotherapy, CPG 7909
- Medical subject headings
- Carcinoma, Neoplasm Metastasis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPG 7909Drug
Also called PF-3512676, ProMune
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.
Herceptin®Drug
Also called trastuzumab
Herceptin® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert
CPG 7909Drug
Also called PF-3512676, ProMune
Each 0.04 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.
Herceptin®Drug
Also called trastuzumab
Herceptin® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert
CPG 7909Drug
Also called PF-3512676, ProMune
Each 0.16 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.
Herceptin®Drug
Also called trastuzumab
Herceptin® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert
CPG 7909Drug
Also called PF-3512676, ProMune
Each 0.32 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.
Herceptin®Drug
Also called trastuzumab
Herceptin® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 0.01 mg/kg CPG 7909 plus Herceptin® Receives: Drug: CPG 7909; Drug: Herceptin® |
| Cohort 2 | Experimental | 0.04 mg/kg CPG 7909 plus Herceptin® Receives: Drug: CPG 7909; Drug: Herceptin® |
| Cohort 3 | Experimental | 0.16 mg/kg CPG 7909 plus Herceptin® Receives: Drug: CPG 7909; Drug: Herceptin® |
| Cohort 4 | Experimental | 0.32 mg/kg CPG 7909 plus Herceptin® Receives: Drug: CPG 7909; Drug: Herceptin® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Phase II: Evaluate tumor response and safety of CPG 7909 in combination with Herceptin® in patients with metastatic breast cancer
Secondary outcomes (2)
Phase I: To evaluate tumor response, duration of response, time to disease progression, and survival time
Phase II: To evaluate duration of response, time to disease progression, and survival time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2002 (estimated)
- Study startOct 2001
- Primary completionJun 2003
- Study completionJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Metastatic BreastStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Harold Burstein, M.D., Ph.D., Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00031278
- Sponsor's protocol ID
- C005
- Other IDs
- C005, A8501020
- Status last verified
- May 2011
- First submitted
- 28 Feb 2002
- Last updated
- 30 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT00031278
- Acronym / sponsor ID
- C005
- Conditions
- Carcinoma, Metastatic Breast
- Keywords
- Metastatic, Breast, Cancer, immunotherapy, CPG 7909
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Oct 2001
- Primary completion
- Jun 2003 (actual)
- Study completion
- Jun 2003 (actual)
- First posted
- 1 Mar 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Phase II part of study not initiated because the development plan modified the route of administration to subcutaneous injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: CPG 7909, Drug: Herceptin®0.01 mg/kg CPG 7909 plus Herceptin® |
| Cohort 2 | Experimental | Drug: CPG 7909, Drug: Herceptin®0.04 mg/kg CPG 7909 plus Herceptin® |
| Cohort 3 | Experimental | Drug: CPG 7909, Drug: Herceptin®0.16 mg/kg CPG 7909 plus Herceptin® |
| Cohort 4 | Experimental | Drug: CPG 7909, Drug: Herceptin®0.32 mg/kg CPG 7909 plus Herceptin® |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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%.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPG 7909Also: PF-3512676, ProMuneEach 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. | Drug | Cohort 1 |
| Herceptin®Also: trastuzumabHerceptin® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert | Drug | Cohort 1 |
| CPG 7909Also: PF-3512676, ProMuneEach 0.04 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. | Drug | Cohort 2 |
| Herceptin®Also: trastuzumabHerceptin® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert | Drug | Cohort 2 |
| CPG 7909Also: PF-3512676, ProMuneEach 0.16 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. | Drug | Cohort 3 |
| Herceptin®Also: trastuzumabHerceptin® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert | Drug | Cohort 3 |
| CPG 7909Also: PF-3512676, ProMuneEach 0.32 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. | Drug | Cohort 4 |
| Herceptin®Also: trastuzumabHerceptin® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert | Drug | Cohort 4 |
Primary outcome
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
Phase II: Evaluate tumor response and safety of CPG 7909 in combination with Herceptin® in patients with metastatic breast cancer
2 secondary outcomes
Phase I: To evaluate tumor response, duration of response, time to disease progression, and survival time
Phase II: To evaluate duration of response, time to disease progression, and survival time
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harold Burstein, M.D., Ph.D. principal investigator
Dana-Farber Cancer Institute
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CPG 7909 and Herceptin® in people with Carcinoma, Metastatic Breast, run by Pfizer at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2011.