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ACTIVE NOT RECRUITING
NCT00616967
PHASE2

Carboplatin and Nab-Paclitaxel With or Without Vorinostat in Treating Women With Newly Diagnosed Operable Breast Cancer

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

View on ClinicalTrials.gov

Summary

RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Vorinostat may also help carboplatin and paclitaxel albumin-stabilized nanoparticle formulation work better by making tumor cells more sensitive to the drugs. Giving chemotherapy with or without vorinostat before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This randomized phase II trial is studying how well giving carboplatin together with paclitaxel albumin-stabilized nanoparticle formulation works with or without vorinostat in treating women with breast cancer that can be removed by surgery.

Official title: A Multi-Institutional Double-Blind Phase II Study Evaluating Response and Surrogate Biomarkers to Carboplatin and Nab-Paclitaxel (CP) With or Without Vorinostat as Preoperative Chemotherapy in HER2-negative Primary Operable Breast Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

68

Start Date

2008-05

Completion Date

2027-02

Last Updated

2026-03-05

Healthy Volunteers

No

Conditions

Interventions

DRUG

carboplatin

Given IV

DRUG

paclitaxel albumin-stabilized nanoparticle formulation

Given IV

DRUG

vorinostat

Given orally

OTHER

placebo

Given orally

Locations (5)

University of Alabama Comprehensive Cancer Center

Birmingham, Alabama, United States

Indiana University Purdue University of Indianapolis

Indianapolis, Indiana, United States

Anne Arundel Health System

Annapolis, Maryland, United States

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Mayo Clinic Cancer Center

Rochester, Minnesota, United States