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Biological Therapy for Breast Cancer
Phase 1 & 2
Waitlist Available
Research Sponsored by St. Luke's Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Performance status: Karnofsky 70-100%
No prior or concurrent malignancy, other than curatively treated carcinoma in situ of the cervix or basal cell skin cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial will test the combination of T cells and interleukin-2 with either a peripheral stem cell transplant or bone marrow transplant to treat women with stage IIIB or metastatic breast cancer.
Who is the study for?
This trial is for women with stage IIIB or metastatic breast cancer. Participants must have normal liver and kidney function, no serious heart disease, not be pregnant, HIV negative, and have a good performance status. They should not have brain metastases or any other current malignancies except certain treated cancers.Check my eligibility
What is being tested?
The study is testing the combination of T cells and interleukin-2 with either peripheral stem cell transplantation or bone marrow transplantation to see if this can more effectively kill tumor cells in women with advanced breast cancer.See study design
What are the potential side effects?
Potential side effects may include immune system reactions, fatigue, risk of infection due to stem cell or bone marrow transplant procedures, and possible organ inflammation from interleukin-2.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am mostly able to care for myself and carry out daily activities.
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I have no other cancers except possibly treated skin cancer or cervical cancer.
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My breast cancer has spread and is confirmed by a biopsy.
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I do not have any signs of cancer spread to my brain.
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My advanced cancer is confirmed by scans or physical exams.
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I do not have serious heart problems like recent heart attacks or heart failure.
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My cancer responded to chemotherapy by shrinking.
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I do not have any severe health or mental health conditions.
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I am 18 years old or older.
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My kidney function is normal.
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
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Who is running the clinical trial?
St. Luke's Medical CenterLead Sponsor
12 Previous Clinical Trials
208,431 Total Patients Enrolled
John P. Hanson, MDStudy ChairSt. Luke's Medical Center
7 Previous Clinical Trials
210 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My condition affects both sides of my body.I am not currently on hormonal therapy for breast cancer.I am mostly able to care for myself and carry out daily activities.I have no other cancers except possibly treated skin cancer or cervical cancer.My breast cancer has spread and is confirmed by a biopsy.I do not have any signs of cancer spread to my brain.My advanced cancer is confirmed by scans or physical exams.I have a non-invasive breast cancer.I do not have serious heart problems like recent heart attacks or heart failure.My cancer responded to chemotherapy by shrinking.I do not have any severe health or mental health conditions.I am 18 years old or older.My kidney function is normal.
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 enrollment for this trial still open?
"Unfortunately, the information on clinicaltrials.gov states that this medical investigation is no longer recruiting patients as it was last updated in December 2013. However, 2600 other trials are still actively enrolling participants at present time."
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