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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 weeks
Treatment ~ Varies
Follow Up ~up to 30 days post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days post-treatment for reporting.

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 more

Trial 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

Carboplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT00616967 — Phase 2
Breast Cancer Research Study Groups: Arm II, Arm I
Breast Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT00616967 — Phase 2
Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00616967 — Phase 2
~4 spots leftby Oct 2025