3-AP and Gemcitabine in Treating Patients With Refractory Metastatic Breast Cancer

Stopped early · Phase 2

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

In brief

Phase II trial to study the effectiveness of combining 3-AP with gemcitabine in treating patients who have refractory metastatic breast cancer. Drugs used in chemotherapy, such as 3-AP and gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining 3-AP with gemcitabine may kill more tumor cells

Key facts

Study ID: NCT00095888
Run by: National Cancer Institute (NCI)
People needed: 68
Starts: 2004-10-01
Last updated by the study team: 2013-01-16

Who can join

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

You may qualify if…

Histologically or cytologically confirmed breast cancer
Refractory metastatic disease
Measurable disease
At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
Must have received 1, and only 1, prior chemotherapy regimen for metastatic disease
Patients overexpressing HER2/neu antigen must have received a prior trastuzumab (Herceptin®)-containing regimen
No known brain metastases
Hormone receptor status:
Not specified
Male or female
Performance status - ECOG 0-2
At least 12 weeks
WBC ≥ 3,000/mm\^3
Absolute neutrophil count ≥ 1,500/mm\^3
Platelet count ≥ 100,000/mm\^3
Bilirubin normal
AST and ALT ≤ 2.5 times upper limit of normal
Creatinine normal
Creatinine clearance ≥ 60 mL/min
No uncontrolled congestive heart failure
No unstable angina pectoris
No cardiac arrhythmia
No severe pulmonary disease requiring oxygen
Not pregnant or nursing
Negative pregnancy test

Where it is running

Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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