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Phase I-II Trial of Vorinostat Plus Weekly Paclitaxel and Trastuzumab Followed by Doxorubicin-Cyclophosphamide in Patients With Locally Advanced Breast Cancer


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Phase I-II Trial of Vorinostat Plus Weekly Paclitaxel and Trastuzumab Followed by Doxorubicin-Cyclophosphamide in Patients With Locally Advanced Breast Cancer


Inclusion Criteria:



- Histologically or cytologically confirmed adenocarcinoma of the breast associated
with the following stages: IIB, IIIA, IIIB or IIIC.

- Tumor must be Her2/neu positive

- No prior chemotherapy, radiation or definitive therapeutic surgery

Exclusion Criteria:

- May not be receiving any other investigational agents

- Uncontrolled intercurrent illness

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the recommended phase II dose of vorinostat in combination with weekly paclitaxel/trastuzumab

Outcome Time Frame:

1 year

Safety Issue:

Yes

Principal Investigator

Joseph Sparano, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Montefiore Medical Center

Authority:

United States: Institutional Review Board

Study ID:

NYCC1

NCT ID:

NCT00574587

Start Date:

December 2007

Completion Date:

January 2010

Related Keywords:

  • Breast Cancer
  • Vorinostat
  • Neoadjuvant Chemotherapy
  • Breast Neoplasms

Name

Location

Montefiore Medical CenterBronx, New York  10467-2490