Preoperative Cisplatin in Early Stage Breast Cancer

Completed · Phase 2

Conditions studied: Breast Cancer

In brief

The purpose of this study is to find out what effects the preoperative therapy cisplatin will have on patients with early stage estrogen receptor-negative (ER-), progesterone receptor-negative (PR-), or HER-2 negative breast cancer.

Key facts

Study ID

NCT00148694

Run by

Dana-Farber Cancer Institute

People needed

27

Starts

2004-07-01

Expected to finish

2010-05-01

Last updated by the study team

2016-08-31

Who can join

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

You may qualify if…

• All tumors must be ER-, PR- and HER-2 negative.
• Age > 18 years
• ECOG performance status of less than or equal to 1
• Absolute neutrophil count (ANC) > 1,500/mm3
• Hemoglobin > 9mm/dl
• Platelets > 100,000/mm3
• Creatinine < 1.5mg/dl
• Glucose < 200mg/dl
• Bilirubin < 1.5 x upper limit of normal (ULN)
• SGOT < 3.0 x ULN

You may not qualify if…

• Prior chemotherapy treatment
• Pregnant or breast-feeding women
• History of serious illness, medical or psychiatric condition requiring medical management
• Uncontrolled infection
• Renal dysfunction
• Active or severe cardiovascular or pulmonary disease
• Peripheral neuropathy of any etiology that exceeds grade 1
• Prior history of malignancy
• Uncontrolled diabetes

Where it is running

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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