Vorinostat and Trastuzumab in Treating Patients With Metastatic or Locally Recurrent Breast Cancer

Completed · Phase 1/Phase 2

Conditions studied: Breast Cancer, Male Breast Cancer, Recurrent Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Stage IV Breast Cancer

In brief

This phase I/II trial is studying the side effects and best dose of vorinostat when given together with trastuzumab and to see how well they work in treating patients with metastatic breast canceror breast cancer that has recurred in the chest wall. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Vorinostat and trastuzumab also may stop the growth of tumor cells by blocking blood flow to the tumor. Giving vorinostat together with trastuzumab may be a better way to block tumor growth.

Key facts

Study ID

NCT00258349

Run by

National Cancer Institute (NCI)

People needed

16

Starts

2006-08-01

Expected to finish

2010-09-01

Last updated by the study team

2014-06-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No active or ongoing infection
• No history of allergic reaction to compounds of similar chemical or biologic composition to vorinostat or other agents used in study
• No psychiatric illness or social situation that would preclude study compliance
• No other uncontrolled illness
• More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin; 1 week for capecitabine) and recovered
• More than 3 weeks since prior radiotherapy and recovered
• Recovered from prior therapy
• At least 2 weeks since prior valproic acid
• More than 4 weeks since prior investigational agents
• More than 4 weeks since prior lapatinib ditosylate
• No concurrent combination antiretroviral therapy for HIV-positive patients
• Measurable disease, defined as >= 1 unidimensionally measurable lesion > 20 mm by conventional techniques or > 10 mm by spiral CT scan
• No other concurrent investigational agents
• Concurrent bisphosphonates allowed provided therapy was initiated prior to study treatment
• No other concurrent anticancer therapy
• Recurrent or progressive disease while receiving prior trastuzumab (Herceptin) (with or without chemotherapy) OR relapsed within 3 months of last dose of prior adjuvant trastuzumab for metastatic disease
• Histologically confirmed breast cancer
• Must overexpress HER-2 gene
• Metastatic or chest wall recurrent disease
• Site of measurable disease must not have been irradiated (except chest wall recurrence treated with adjuvant radiation therapy)
• No untreated brain metastases
• Previously treated brain metastasis responsive to radiotherapy and/or surgery allowed provided the brain is not the sole site of measurable disease

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Mercy Capitol — Des Moines, Iowa, United States
• Iowa Methodist Medical Center — Des Moines, Iowa, United States
• Iowa Oncology Research Association CCOP — Des Moines, Iowa, United States
• Medical Oncology and Hematology Associates-Des Moines — Des Moines, Iowa, United States
• Medical Oncology and Hematology Associates — Des Moines, Iowa, United States
• Mercy Medical Center - Des Moines — Des Moines, Iowa, United States
• Iowa Lutheran Hospital — Des Moines, Iowa, United States
• Siouxland Hematology Oncology Associates — Sioux City, Iowa, United States
• Mercy Medical Center-Sioux City — Sioux City, Iowa, United States
• Saint Luke's Regional Medical Center — Sioux City, Iowa, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Eastern Cooperative Oncology Group — Boston, Massachusetts, United States
• Hutchinson Area Health Care — Hutchinson, Minnesota, United States
• Meeker County Memorial Hospital — Litchfield, Minnesota, United States
• Saint John's Hospital - Healtheast — Maplewood, Minnesota, United States
• Virginia Piper Cancer Institute — Minneapolis, Minnesota, United States
• Hennepin County Medical Center — Minneapolis, Minnesota, United States
• Regions Hospital — Saint Paul, Minnesota, United States
• Saint Joseph's Hospital - Healtheast — Saint Paul, Minnesota, United States
• Saint Francis Regional Medical Center — Shakopee, Minnesota, United States
• Woodwinds Health Campus — Woodbury, Minnesota, United States
• Saint Vincent's Hospital and Medical Center of New York — New York, New York, United States
• Albert Einstein College of Medicine — The Bronx, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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