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Alkylating agents
Chemotherapy +/- Erbitux for Breast Cancer (CA225200 Trial)
Phase 2
Waitlist Available
Led By Joyce A. O'Shaughnessy, MD
Research Sponsored by US Oncology Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has cytologically or pathologically confirmed breast cancer with documented HER2+ (positive) or HER2- (negative) disease
Has had up to 1 prior chemotherapy regimens for metastatic disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
CA225200 Trial Summary
This trial is testing a combination of drugs to treat metastatic breast cancer, with or without the drug Erbitux.
Who is the study for?
This trial is for adults with Stage IV metastatic breast cancer who've had up to one prior chemo regimen and no past treatment with irinotecan, carboplatin, or cisplatin. They must have measurable disease per RECIST Criteria and provide tissue samples. HER2 status needs documentation, and those with HER2+ must have had Herceptin therapy.Check my eligibility
What is being tested?
The study aims to compare the effectiveness of two chemotherapy combinations in treating metastatic breast cancer: irinotecan + carboplatin + erbitux versus irinotecan + carboplatin alone. The main goal is to see how well tumors respond to these treatments.See study design
What are the potential side effects?
Potential side effects include reactions related to infusion, gastrointestinal issues like diarrhea from irinotecan, low blood counts due to carboplatin, and skin reactions that might be caused by Erbitux.
CA225200 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer is confirmed and tested for HER2 status.
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I have had one chemotherapy treatment for my advanced cancer.
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I have not been treated with irinotecan, carboplatin, or cisplatin.
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My breast cancer can be measured by standard health tests.
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I am able to get out of my bed or chair and move around.
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I am over 18 years old.
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I have breast cancer tissue samples available for testing.
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I have received Herceptin for my HER2+ breast cancer.
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My breast cancer has spread to other parts of my body.
CA225200 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rates (ORR)
Secondary outcome measures
Duration of Response
Median Overall Survival (OS)
Median Time of Progression-free Survival (PFS)
CA225200 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 2Experimental Treatment1 Intervention
irinotecan 90mg/m2, carboplatin AUC=2.0 on Days 1 and 8 of each 21- day cycle plus Erbitux 400 mg/m2 Week 1 and then 250 mg/m2 weekly thereafter, (Arm 2, ICb+Erbitux)
Group II: Arm 1Active Control1 Intervention
irinotecan 90 mg/m2 and carboplatin AUC=2.0 on Days 1 and 8 of each 21-day cycle (Arm 1, ICb)
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Who is running the clinical trial?
PfizerIndustry Sponsor
4,567 Previous Clinical Trials
10,911,719 Total Patients Enrolled
111 Trials studying Breast Cancer
36,404 Patients Enrolled for Breast Cancer
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,360 Total Patients Enrolled
51 Trials studying Breast Cancer
8,265 Patients Enrolled for Breast Cancer
US Oncology ResearchLead Sponsor
37 Previous Clinical Trials
17,308 Total Patients Enrolled
5 Trials studying Breast Cancer
4,252 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My breast cancer is confirmed and tested for HER2 status.I have had one chemotherapy treatment for my advanced cancer.I have not been treated with irinotecan, carboplatin, or cisplatin.I have been treated with irinotecan, carboplatin, or cisplatin before.I have been treated with drugs targeting EGFR. I've had Herceptin if my cancer is HER2+.I have early or nonmeasurable metastatic breast cancer, or a different condition than specified in the first criterion.I have brain metastases that are causing symptoms or haven't been treated.My breast cancer can be measured by standard health tests.I am currently taking a tyrosine kinase inhibitor medication.I have heart disease that is not well-controlled or had a heart attack in the last year.I am able to get out of my bed or chair and move around.I am over 18 years old.I finished my last radiation therapy more than 2 weeks ago.I have acute hepatitis or am HIV positive.I have had another type of cancer in the last 5 years that could interfere with my breast cancer diagnosis.I finished chemotherapy less than 3 weeks ago.I had major surgery less than 3 weeks ago and haven't fully recovered.I have not taken any cancer immunotherapy or hormone therapy in the last 2 weeks.I have had a stem cell or bone marrow transplant for blood cancer.I have breast cancer tissue samples available for testing.I have an ongoing or untreated infection.I have significant nerve pain or tingling in my hands or feet.I have received an organ transplant that is not corneal, bone, or skin.I do not have any major health issues that could affect the study.I have received Herceptin for my HER2+ breast cancer.My breast cancer has spread to other parts of my body.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1
- Group 2: Arm 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can non-participants still join this study?
"Unfortunately, this particular trial is no longer actively recruiting patients. However, there are presently 2383 trials actively searching for participants with malignant neoplasms and 1081 trials for irinotecan + Carboplatin + erbitux admitting patients."
Answered by AI
Is this trial being run in multiple hospitals within the city limits?
"To lessen the inconvenience for participants, this clinical trial enrolled patients at 58 sites. The locations are Dallas, Kettering and Seneca along with 55 other locations."
Answered by AI
Does the combination of irinotecan, Carboplatin and erbitux create significant health risks?
"This drug combination has shown some evidence of safety in Phase 2 trials, but there is no data yet supporting its efficacy. Therefore, our team at Power estimates the safety to be a 2."
Answered by AI
Does this research stand alone or has it been backed by other investigations?
"As of now, there are 1081 active clinical trials related to irinotecan + Carboplatin + erbitux. Out of those, 296 are in Phase 3. Even though most of the trials for irinotecan + Carboplatin + erbitux take place in Shanghai, there are a total 56763 locations around the world where these studies are being conducted."
Answered by AI
Erbitux, Carboplatin, and irinotecan are often prescribed for what reason?
"Irinotecan + carboplatin + erbitux is a common treatment for advanced endometrial cancer, but it can also be effective against other conditions like melanoma, lymphoma, non-hodgkin's lymphoma, and malignant neoplasms."
Answered by AI
How many people are included in this medical research?
"This study is no longer admitting patients. It was originally posted on July 28th, 2005 and last updated December 3rd, 2021. However, there are 2383 other clinical trials for cancer patients and 1081 studies involving irinotecan + Carboplatin + erbitux that are still enrolling participants."
Answered by AI
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