Tipifarnib and Combination Chemotherapy in Treating Patients With Stage II or Stage III Breast Cancer

Completed · Phase 1/Phase 2

Conditions studied: Breast Cancer, Male Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer

In brief

Tipifarnib may stop the growth of breast cancer by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as paclitaxel, doxorubicin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving tipifarnib together with combination chemotherapy may kill more tumor cells. This phase I/II trial is studying the side effects and best dose of tipifarnib when given together with combination chemotherapy and to see how well they work in treating patients with stage II or stage III breast cancer.

Key facts

Study ID

NCT00470301

Run by

National Cancer Institute (NCI)

People needed

60

Starts

2007-04-01

Expected to finish

2013-09-01

Last updated by the study team

2021-02-16

Who can join

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

You may qualify if…

• Histologically or cytologically confirmed adenocarcinoma of the breast; clinical stage IIB, IIIA, IIIB, or IIIC disease
• At least 1 week since prior tamoxifen or other selective estrogen receptor modulator for prevention or for other indications (e.g., osteoporosis or prior ductal carcinoma in situ)
• HER-2/neu-negative by immunohistochemistry or fluorescence in situ hybridization (FISH)
• Hormone receptor status:
• Estrogen and/or progesterone receptor-positive* [Note: *Patients enrolled on the phase I portion of the trial may have estrogen and progesterone receptor-negative disease]
• Normal organ function including:
• 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
• LVEF normal by echocardiogram or nuclear scan
• Creatinine normal OR Creatinine clearance >= 60 mL/min
• FEV1 >= 1 L* and DLCO >= 50%* [Note: *Only if baseline CT scan of chest shows parenchymal lung disease OR there is a history of chronic obstructive or other pulmonary disease]
• No prior chemotherapy, radiotherapy, or definitive therapeutic surgery (e.g., mastectomy, lumpectomy, or axillary dissection) for this cancer but prior sentinel lymph node biopsy for this malignancy allowed
• No prior adjuvant chemotherapy for a previous breast malignancy
• No concurrent combination antiretroviral therapy for HIV-positive patients
• No other concurrent investigational agents
• No other concurrent anticancer agents or therapies
• ECOG performance status 0-1
• Fertile patients must use effective contraception

You may not qualify if…

• No other invasive malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
• No history of allergic reactions attributed to compounds of similar chemical or biological composition to tipifarnib or other study drugs (e.g., imidazoles or quinolones)
• No other uncontrolled illness including, but not limited to, any of the following: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/social situations that would preclude study compliance
• Not pregnant or nursing

Where it is running

• H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States
• Mount Sinai Medical Center — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Weill Medical College of Cornell University — 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
• M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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