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Alkylating agents
Carboplatin + Nab-Paclitaxel +/- Vorinostat for Breast Cancer
Phase 2
Waitlist Available
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and day 15
Summary
This trial is studying carboplatin and paclitaxel albumin-stabilized nanoparticle formulation with or without vorinostat in treating patients with breast cancer.
Who is the study for?
This trial is for women with newly diagnosed operable breast cancer. Participants should have specific types of breast cancer, meet certain blood and organ function criteria, agree to non-hormonal contraception, and not be pregnant or nursing. Those with severe complications risk, prior systemic treatment for this cancer, or other exclusions cannot join.
What is being tested?
The study tests how well carboplatin and nab-paclitaxel chemotherapy work when given with or without vorinostat before surgery. The goal is to see if adding vorinostat makes the chemo more effective in shrinking tumors in preparation for surgical removal.
What are the potential side effects?
Possible side effects include reactions related to chemotherapy such as nausea, fatigue, hair loss, low blood cell counts leading to increased infection risk; and from vorinostat: diarrhea, changes in taste sensation, dry mouth or dehydration.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 30 days post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days post-treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Pathological Complete Response (pCR) Rate
Secondary study objectives
Change in Cumulative Methylation Index (CMI)
Change in Standard Uptake Value (SULmax) From Baseline to Day 15 on FDG-PET
Number of Participants With Clinical Complete Response (cCR)
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm IIExperimental Treatment3 Interventions
Patients receive carboplatin and paclitaxel albumin-stabilized nanoparticle formulation as in arm I and oral vorinostat on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.
Group II: Arm IActive Control3 Interventions
Patients receive carboplatin IV and paclitaxel albumin-stabilized nanoparticle formulation IV on day 1 and an oral placebo on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
carboplatin
2010
Completed Phase 3
~4790
paclitaxel albumin-stabilized nanoparticle formulation
2008
Completed Phase 2
~1070
vorinostat
2005
Completed Phase 2
~770
Find a Location
Who is running the clinical trial?
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
570 Previous Clinical Trials
33,312 Total Patients Enrolled
44 Trials studying Breast Cancer
4,904 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,886 Previous Clinical Trials
41,020,869 Total Patients Enrolled
946 Trials studying Breast Cancer
1,545,545 Patients Enrolled for Breast Cancer
Vered Stearns, MDStudy ChairSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
13 Previous Clinical Trials
802 Total Patients Enrolled
11 Trials studying Breast Cancer
765 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had any cancer except for skin cancer in the last 5 years.I am currently taking medication that affects cell DNA.I am not taking any experimental drugs.I have a history of cancer.My menopausal status is not relevant.I am currently receiving or have received systemic treatment for my cancer.I am not currently undergoing any chemotherapy, hormone therapy, radiation, or experimental treatments.I am currently on a biological therapy.My breast cancer is of the infiltrating lobular type.I have had a condition where my lymphocytes grow abnormally.My kidney function is reduced with a creatinine clearance below 50 mL/min.I have moderate to severe numbness, tingling, or pain in my hands or feet.My cancer is not HER2 positive.My heart's electrical activity shows delays on an ECG.I am allergic to medications similar to vorinostat.My breast cancer is both ductal and lobular.My cancer is at a stage where it can't be removed by surgery and can be measured.Your bilirubin levels are within the normal range.Your white blood cell count is at least 1,500 per cubic millimeter.I am fully active or can carry out light work.Your hemoglobin level is at least 9 grams per deciliter.Your kidneys work well enough to filter out waste from your blood.Your liver enzymes (AST and ALT) should not be more than 2.5 times the upper limit of normal.I have no allergies to vorinostat or similar drugs.Your blood clotting tests should be within a certain range, and if you are taking warfarin, your dose should be stable.I have no severe allergies to drugs with polysorbate 80 or E. coli products.I am on HIV medication.Your creatinine levels are within a certain range.Your blood clotting test results are higher than the normal range.My cancer's hormone receptor status meets the trial's criteria.Your platelet count is at least 150,000 per cubic millimeter.Your alkaline phosphatase levels are not more than 2.5 times the normal upper limit.I am severely allergic to drugs with polysorbate 80 or E. coli products.My breast cancer was confirmed by a biopsy.I have skin cancer spread to the same side breast and will undergo chemotherapy before surgery.I do not have severe nerve damage in my hands or feet.My heart's electrical activity is normal according to my last ECG.I stopped taking breast cancer prevention medication like tamoxifen over a month ago.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II
- Group 2: Arm I
Awards:
This trial has 0 awards, including: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.
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