Tipifarnib, Doxorubicin, and Cyclophosphamide in Treating Women With Locally Advanced Breast Cancer
Completed · Phase 2
Conditions studied: Inflammatory Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer
In brief
Drugs used in chemotherapy, such as doxorubicin and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining tipifarnib with doxorubicin and cyclophosphamide may kill more tumor cells. Phase II trial to study the effectiveness of combining tipifarnib with doxorubicin and cyclophosphamide in treating women who have locally advanced breast cancer.
Key facts
- Study ID
- NCT00049114
- Run by
- National Cancer Institute (NCI)
- People needed
- 62
- Starts
- 2003-02-01
- Last updated by the study team
- 2013-06-06
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Histologically or cytologically confirmed adenocarcinoma of the breast
- Phase I (closed to accrual as of 1/19/04):
- Nonregional stage IV disease
- Phase II:
- Locally advanced disease, according to AJCC staging criteria:
- Stage IIB
- Stage IIIA
- Stage IIIB
- Stage IIIC
- At least 1 bidimensionally or unidimensionally measurable indicator lesion
- Hormone receptor status:
- Not specified
- Female
- Performance status - ECOG 0-1
- Performance status - Karnofsky 70-100%
- Not specified
- WBC at least 3,000/mm\^3
- Absolute neutrophil count at least 1,500/mm\^3
- Platelet count at least 100,000/mm\^3
- Bilirubin normal
- AST/ALT no greater than 2.5 times upper limit of normal
- Creatinine normal
- Creatinine clearance at least 60 mL/min
- LVEF normal
- No symptomatic congestive heart failure
Where it is running
- Albert Einstein College of Medicine — The Bronx, New York, United States
Full record on ClinicalTrials.gov
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