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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT00616967
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • carboplatin — DRUG
    Given IV
  • paclitaxel albumin-stabilized nanoparticle formulation — DRUG
    Given IV
  • vorinostat — DRUG
    Given orally
  • placebo — OTHER
    Given orally

Study Details

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.

Key Dates

Start date
May 31, 2008
Status verified
Feb 2026
Primary completion
Jun 30, 2014
Completion
Feb 28, 2027

Study Design

Enrollment
68 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm I
    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.
  • Experimental: Arm II
    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.

Primary Outcome Measure

Pathological Complete Response (pCR) Rate [ Time Frame: Time of breast cancer surgery ]

Locations (5)

FacilityCityStateZIPSite coordinators
University of Alabama Comprehensive Cancer CenterBirminghamAlabama35249-
Indiana University Purdue University of IndianapolisIndianapolisIndiana46202-
Anne Arundel Health SystemAnnapolisMaryland21401-
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimoreMaryland21231-2410-
Mayo Clinic Cancer CenterRochesterMinnesota55905-

Find similar trials in Birmingham, AL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
University of Alabama Comprehensive Cancer Center· Birmingham, ALIndiana University Purdue University of Indianapolis· Indianapolis, INAnne Arundel Health System· Annapolis, MDSidney Kimmel Comprehensive Cancer Center at Johns Hopkins· Baltimore, MDMayo Clinic Cancer Center· Rochester, MN

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