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Status:

ACTIVE_NOT_RECRUITING

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

Lead Sponsor:

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Breast Cancer

Eligibility:

FEMALE

18+ years

Phase:

PHASE2

Brief 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 c...

Detailed Description

OBJECTIVES: Primary * To determine pathological complete response (pCR) rates in patients with HER2-negative primary operable breast cancer treated with neoadjuvant therapy comprising carboplatin an...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed infiltrating ductal breast cancer by core needle biopsy
  • Mixed ductal and lobular disease allowed
  • Infiltrating lobular cancer allowed in the run-in portion only
  • Unresected, clinically measurable disease, meeting 1 of the following clinical staging criteria:
  • T2, T3, or T4 lesion, any N, M0
  • T1c, N1-3,M0
  • Patients with skin metastases to the ipsilateral breast for whom chemotherapy is planned prior to definitive surgery are eligible for the primary study portion
  • HER2-negative disease
  • Hormone receptor status\* meeting 1 of the following criteria:
  • Estrogen receptor (ER)-negative and progesterone receptor (PR)-negative
  • ER-positive (grade II or III) and PR-positive or PR-negative NOTE: \*Any ER or PR status for the run-in portion
  • PATIENT CHARACTERISTICS:
  • ECOG performance status 0-1
  • Menopausal status not specified
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 150,000/mm³
  • Hemoglobin ≥ 9 g/dL
  • Creatinine ≤ 1.5 times the upper limit of normal (ULN)
  • Creatinine clearance ≥ 50 mL/min
  • Total bilirubin normal
  • AST(SGOT) and ALT(SGPT) ≤ 2.5 times (ULN)
  • alkaline phosphatase ≤ 2.5 times ULN
  • PT such that INR ≤ 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin) and PTT ≤ ULN
  • Adequate cardiac function defined as no evidence of PR prolongation or AV block on baseline electrocardiogram (ECG)
  • Willing to use effective, non-hormonal contraception while on treatment and for at least 3 months thereafter
  • Not pregnant or nursing
  • No pre-existing peripheral neuropathy ≥ grade 2
  • No history of severe hypersensitivity reaction to any drug formulated with polysorbate 80 or to E. coli-derived products
  • No history of allergic reactions attributed to compounds of similar chemical or biologic composition to vorinostat
  • No medical condition which, in the opinion of the investigator, puts the patient at risk of potentially serious complications while on this therapy
  • PRIOR CONCURRENT THERAPY:
  • At least 4 weeks since prior valproic acid or other histone deacetylase inhibitor
  • No prior chemotherapy, radiotherapy, or endocrine therapy for this cancer
  • Prior tamoxifen or raloxifene or another agent for prevention of breast cancer allowed as long as the patient has discontinued the treatment ≥ 1 month prior to baseline study biopsy
  • No systemic treatment for prior cancer within the past 5 years (primary study portion)
  • No prior or ongoing systemic treatment for this cancer (primary study portion)
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent histone deacetylase inhibitor
  • No other concurrent chemotherapy, antiestrogen therapy, radiotherapy, or other investigational systemic therapy
  • No other concurrent biologic therapy
  • No other concurrent investigational drugs

Exclusion

    Key Trial Info

    Start Date :

    May 1 2008

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    February 1 2026

    Estimated Enrollment :

    68 Patients enrolled

    Trial Details

    Trial ID

    NCT00616967

    Start Date

    May 1 2008

    End Date

    February 1 2026

    Last Update

    February 27 2025

    Active Locations (5)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (5 locations)

    1

    University of Alabama Comprehensive Cancer Center

    Birmingham, Alabama, United States, 35249

    2

    Indiana University Purdue University of Indianapolis

    Indianapolis, Indiana, United States, 46202

    3

    Anne Arundel Health System

    Annapolis, Maryland, United States, 21401

    4

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, United States, 21231-2410