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Monoclonal Antibodies
Monoclonal Antibody Therapy for Breast Cancer
Phase 1 & 2
Waitlist Available
Led By Mark D. Pegram, MD
Research Sponsored by Jonsson Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Previously treated with an anthracycline and a taxane in any combination for breast cancer
Measurable disease with at least one unidimensionally measurable lesion not previously irradiated
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing a monoclonal antibody therapy to see if it can kill breast cancer cells without harming normal cells.
Who is the study for?
This trial is for women over 18 with advanced or metastatic breast cancer, previously treated with specific chemotherapies. They must have measurable disease, no severe additional illnesses, and not be pregnant or nursing. Participants should use contraception and meet certain blood, liver, heart, and kidney health standards.Check my eligibility
What is being tested?
The study tests monoclonal antibody therapy's impact on the body and its effectiveness against breast cancer that has spread or cannot be removed by surgery after prior chemotherapy treatments. It's a Phase I/II trial focusing on tumor-targeting antibodies.See study design
What are the potential side effects?
Monoclonal antibody therapy may cause immune reactions leading to inflammation in various organs, allergic responses during infusion into the bloodstream, fatigue due to immune system activation, potential digestive issues like nausea or diarrhea.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been treated with anthracycline and taxane for breast cancer.
Select...
I have at least one cancer lesion that can be measured and hasn't been treated with radiation.
Select...
My breast cancer diagnosis was confirmed through tissue examination.
Select...
I can take care of myself and perform light activities.
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I am female.
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My liver function tests are within the required limits.
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My kidney function is normal, without high uric acid or calcium levels.
Select...
I am legally capable of making my own decisions.
Select...
My cancer has spread beyond its original location.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,153 Total Patients Enrolled
939 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
Jonsson Comprehensive Cancer CenterLead Sponsor
359 Previous Clinical Trials
26,075 Total Patients Enrolled
23 Trials studying Breast Cancer
1,758 Patients Enrolled for Breast Cancer
Mark D. Pegram, MDPrincipal InvestigatorJonsson Comprehensive Cancer Center
7 Previous Clinical Trials
85 Total Patients Enrolled
3 Trials studying Breast Cancer
49 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been treated with anthracycline and taxane for breast cancer.My cancer has not spread to my bones, brain, or caused fluid build-up in my body.I am not receiving any other immunotherapy treatments.I am not currently receiving chemotherapy for metastatic breast cancer.It has been over 4 weeks since my last radiotherapy, except for pain relief.I am not on long-term steroid medication.I have undergone more than 2 chemotherapy treatments.I have had more than one treatment for cancer that has spread far from where it started.I am not currently on hormone therapy for breast cancer.It has been over 2 weeks since my last blood transfusion.I am not receiving any other cancer treatments.My breast cancer diagnosis was confirmed through tissue examination.I can take care of myself and perform light activities.I am female.My liver function tests are within the required limits.My kidney function is normal, without high uric acid or calcium levels.My heart's pumping ability is at least 45%.I will use birth control during and for 3-6 months after the study.I haven't had cancer in the last 5 years, except for skin cancer or cervical pre-cancer.I am legally capable of making my own decisions.I am not receiving any cancer radiation treatment, except for pain relief.It's been over 2 weeks since I last received growth factors for blood cell recovery.I have at least one cancer lesion that can be measured and hasn't been treated with radiation.It has been over 4 weeks since my last chemotherapy.My cancer's hormone receptor status is not determined.I have had any number of hormone or biological treatments.I do not have inflammatory breast cancer.My cancer has spread beyond its original location.I am not taking high doses of corticosteroids.It has been over 4 weeks since my last major surgery.I am 18 years old or older.I don't have any other serious illnesses that would make it unsafe for me to join.
Research Study Groups:
This trial has the following groups: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.
Is the recruitment period for this trial still underway?
"Contrary to clinicaltrials.gov's information, this medical study is no longer accepting patients; first posted on May 1st 2003 and last updated December 3rd 2013. In spite of its inactive status, 2596 other trials are actively seeking participants at present."
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