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Anti-tumor antibiotic
Chemotherapy + Stem Cell Transplant for Advanced Breast Cancer
Phase 2
Waitlist Available
Research Sponsored by Herbert Irving Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No brain metastases
Hepatic: Bilirubin normal (unless benign congenital hyperbilirubinemia is present), No AST/ALT greater than 1.5 times upper limit of normal (ULN) together with alkaline phosphatase greater than 2.5 times ULN, No active hepatitis B or C
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is comparing the effects of two different treatments for stage IV breast cancer. One treatment is just chemotherapy, while the other is chemotherapy plus a stem cell transplant.
Who is the study for?
This trial is for women aged 18-59 with stage IV breast cancer without brain metastases or serious health issues. They must not be pregnant, HIV positive, or have had certain other cancers. Participants need a good performance status and adequate organ function, including normal blood counts and liver enzymes.Check my eligibility
What is being tested?
The study is testing if high-dose chemotherapy followed by peripheral stem cell transplantation can more effectively treat stage IV breast cancer compared to chemotherapy alone. Women will be randomly assigned to one of the two treatment approaches.See study design
What are the potential side effects?
Chemotherapy may cause nausea, fatigue, hair loss, increased risk of infection due to low blood counts, and potential damage to organs like the heart and liver. Stem cell transplantation carries risks such as severe infections and graft-versus-host disease.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has not spread to my brain.
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My liver function is normal, and I don't have active hepatitis B or C.
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My heart functions normally, and I have no history of heart disease or heart attacks.
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I am between 18 and 59 years old.
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My kidney function, measured by creatinine, is normal.
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My breast cancer is confirmed to be at stage IV.
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I am female.
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My cancer has only spread to my bones.
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I am mostly independent and active.
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?
Herbert Irving Comprehensive Cancer CenterLead Sponsor
33 Previous Clinical Trials
929 Total Patients Enrolled
3 Trials studying Breast Cancer
160 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,621 Previous Clinical Trials
40,927,422 Total Patients Enrolled
938 Trials studying Breast Cancer
1,543,343 Patients Enrolled for Breast Cancer
Linda T. Vahdat, MDStudy ChairHerbert Irving Comprehensive Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 59 years old.My kidney function, measured by creatinine, is normal.I haven't had chemotherapy for metastatic disease or used specific drugs, but I may have had adjuvant chemotherapy over 6 months ago.My cancer has not spread to my brain.My liver function is normal, and I don't have active hepatitis B or C.My heart functions normally, and I have no history of heart disease or heart attacks.My breast cancer is confirmed to be at stage IV.I am not receiving any other cancer treatments.I am female.My cancer has only spread to my bones.It has been more than 2 weeks since my last major surgery.I am mostly independent and active.I haven't had radiation to my brain or most of my pelvis, but it's okay if I had it on my lower pelvis.
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 there a high risk of serious side effects for patients who undergo this treatment?
"While there is some clinical data backing the safety of this treatment, it only received a score of 2."
Answered by AI
Are volunteers still being accepted for this experiment?
"The clinical trial mentioned is not currently looking for new participants. It was last updated in 2014 and has not been recruiting since then. There are, however, 2698 other trials that are actively enrolling patients right now."
Answered by AI
Does the age limit for this test allow people who are over 75 years old to participate?
"The trial's requirements state that all participants must be between 18-59 years old."
Answered by AI
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