Carcinoma, BreastPhase 2NCT00043394
CPG 7909 Plus Herceptin® In Patients With Metastatic Breast Cancer
A Phase 2 study testing 0.04 mg/kg CpG 7909, Herceptin® and 0.08 mg/kg CpG 7909 in people with Carcinoma, Breast, run by Pfizer at 12 sites in United States.
Trial summary
To determine the safety and efficacy of CPG 7909 Injection given with Herceptin to patients with metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Carcinoma, Breast
- What is being tested?
- 0.04 mg/kg CpG 7909, Herceptin® and 0.08 mg/kg CpG 7909
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 12 sitesUnited States
- Study dates
- Sep 2002to Oct 2003
- Phase
- Phase 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 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
Who cannot join
- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Pfizer Investigational Site
Ann Arbor, Michigan, 48109
Pfizer Investigational Site
Berkely, California, 94704
Pfizer Investigational Site
Burlington, Vermont, 05401-3456
Pfizer Investigational Site
Cleveland, Ohio, 44195
Pfizer Investigational Site
Dearborn, Michigan, 48126-2641
Pfizer Investigational Site
Detroit, Michigan, 48202
Pfizer Investigational Site
New Haven, Connecticut, 06510
Pfizer Investigational Site
Orange, California, 92868
Pfizer Investigational Site
Palm Springs, California, 92262
Pfizer Investigational Site
Plantation, Florida, 33324
Pfizer Investigational Site
Washington D.C., District of Columbia, 20007-2197
Pfizer Investigational Site
West Bloomfield, Michigan, 48322-3013
About this study
Official title: A Phase I/II Open Label, Multi-Center, Dose-Escalation Study Of Subcutaneous 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.
- Conditions
- Carcinoma, Breast
- Being tested
- 0.04 mg/kg CpG 7909, Herceptin®, 0.08 mg/kg CpG 7909, 0.12 mg/kg CpG 7909, 0.16 mg/kg CpG 7909
- Keywords
- CpG 7909 subcutaneous injection combination with Herceptin® metastatic breast cancer.
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.04 mg/kg CpG 7909Drug
Also called PF-03512676, ProMune
0.04 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks
Herceptin®Drug
Also called Trastuzumab
Herceptin® (maintenance dose per the manufacturer's directions) followed by a subcutaneous injection of CpG 7909.
0.08 mg/kg CpG 7909Drug
Also called PF-03512676, ProMune
0.08 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks
Herceptin®Drug
Also called Trastuzumab
Herceptin® (maintenance dose per the manufacturer's directions) followed by a subcutaneous injection of CpG 7909.
0.12 mg/kg CpG 7909Drug
Also called PF-03512676, ProMune
0.12 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks
Herceptin®Drug
Also called Trastuzumab
Herceptin® (maintenance dose per the manufacturer's directions) followed by a subcutaneous injection of CpG 7909.
0.16 mg/kg CpG 7909Drug
Also called PF-03512676, ProMune
0.16 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks
Herceptin®Drug
Also called Trastuzumab
Herceptin® (maintenance dose per the manufacturer's directions) followed by a subcutaneous injection of CpG 7909.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 0.04 mg/kg CpG 7909 Receives: Drug: 0.04 mg/kg CpG 7909; Drug: Herceptin® |
| Cohort 2 | Experimental | 0.08 mg/kg CpG 7909 Receives: Drug: 0.08 mg/kg CpG 7909; Drug: Herceptin® |
| Cohort 3 | Experimental | 0.12 mg/kg CpG 7909 Injection once weekly Receives: Drug: 0.12 mg/kg CpG 7909; Drug: Herceptin® |
| Cohort 4 | Experimental | 0.16 mg/kg CpG 7909 Receives: Drug: 0.16 mg/kg 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 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®
Measured: 24 weeks
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.
Measured: 24 weeks
Secondary outcomes (2)
Phase I To evaluate tumor response, duration of response, time to disease progression, ECOG performance status, and survival time.
Measured: 24 weeks
Phase II To evaluate duration of response, time to disease progression, ECOG performance status, and survival time.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2002 (estimated)
- Study startSep 2002
- Primary completionOct 2003
- Study completionOct 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00043394
- Sponsor's protocol ID
- C015
- Other IDs
- A8501021, CO15
- Status last verified
- Mar 2009
- First submitted
- 8 Aug 2002
- Last updated
- 12 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Open Label, Multi-Center, Dose-Escalation Study Of Subcutaneous CPG 7909 Plus Herceptin® In Patients With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00043394
- Acronym / sponsor ID
- C015
- Conditions
- Carcinoma, Breast
- Keywords
- CpG 7909 subcutaneous injection combination with Herceptin® metastatic breast cancer.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 2002
- Primary completion
- Oct 2003 (actual)
- Study completion
- Oct 2003 (actual)
- First posted
- 12 Aug 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.
To determine the safety and efficacy of CPG 7909 Injection given with Herceptin to patients with metastatic breast cancer.
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: 0.04 mg/kg CpG 7909, Drug: Herceptin®0.04 mg/kg CpG 7909 |
| Cohort 2 | Experimental | Drug: 0.08 mg/kg CpG 7909, Drug: Herceptin®0.08 mg/kg CpG 7909 |
| Cohort 3 | Experimental | Drug: 0.12 mg/kg CpG 7909, Drug: Herceptin®0.12 mg/kg CpG 7909 Injection once weekly |
| Cohort 4 | Experimental | Drug: 0.16 mg/kg CpG 7909, Drug: Herceptin®0.16 mg/kg CpG 7909 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 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 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| 0.04 mg/kg CpG 7909Also: PF-03512676, ProMune0.04 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks | Drug | Cohort 1 |
| Herceptin®Also: TrastuzumabHerceptin® (maintenance dose per the manufacturer's directions) followed by a subcutaneous injection of CpG 7909. | Drug | Cohort 1 |
| 0.08 mg/kg CpG 7909Also: PF-03512676, ProMune0.08 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks | Drug | Cohort 2 |
| Herceptin®Also: TrastuzumabHerceptin® (maintenance dose per the manufacturer's directions) followed by a subcutaneous injection of CpG 7909. | Drug | Cohort 2 |
| 0.12 mg/kg CpG 7909Also: PF-03512676, ProMune0.12 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks | Drug | Cohort 3 |
| Herceptin®Also: TrastuzumabHerceptin® (maintenance dose per the manufacturer's directions) followed by a subcutaneous injection of CpG 7909. | Drug | Cohort 3 |
| 0.16 mg/kg CpG 7909Also: PF-03512676, ProMune0.16 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks | Drug | Cohort 4 |
| Herceptin®Also: TrastuzumabHerceptin® (maintenance dose per the manufacturer's directions) followed by a subcutaneous injection of CpG 7909. | Drug | Cohort 4 |
Primary outcome
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
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
2 secondary outcomes
Phase I To evaluate tumor response, duration of response, time to disease progression, ECOG performance status, and survival time.
Time frame: 24 weeks
Phase II To evaluate duration of response, time to disease progression, ECOG performance status, and survival time.
Time frame: 24 weeks
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 12 Mar 2009.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Carcinoma, Breast
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Pfizer CT.gov Call Center study director
Pfizer
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 0.04 mg/kg CpG 7909, Herceptin® and 0.08 mg/kg CpG 7909 in people with Carcinoma, Breast, run by Pfizer at 12 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 4 inclusion and 3 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 12 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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 phase mean?
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 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). 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 12 Mar 2009.