| Inclusion Criteria: | 1) Patients must have histologically or cytologically confirmed adenocarcinoma of the breast associated with the following clinical stage: IIB, IIIA, IIIB, or IIIC. The tumor must be estrogen and/or progesterone receptor positive, and Her2/neu negative (by DAKO Herceptest or FISH). Only patients with inflammatory breast cancer (IBC) will be enrolled onto this study at UTMDACC. Patients with IBC must have HER2 negative, and hormone receptor positive or negative.
2) No prior chemotherapy, irradiation, or definitive therapeutic surgery (eg, mastectomy or lumpectomy or axillary dissection) for this malignancy. Patients who have had a prior sentinel lymph node biopsy for this malignancy are eligible.
3) Patients who received tamoxifen or another selective estrogen receptor modulator (SERM) for prevention or for other indications (e.g., osteoporosis, prior DCIS) are eligible. Tamoxifen therapy or other SERMs should be discontinued at least 1 week before the patient is enrolled on this study.
4) Age >/= 18 years. Because breast carcinoma is a disease of adults that rarely occurs in children, children are excluded from this study.
5) ECOG performance status 0 or 1.
6) Patients must have normal organ and marrow function as defined below: - leukocytes >/= 3,000/µl - absolute neutrophil count >/= 1,500/µl - platelets >/= 100,000/µl - total bilirubin within normal institutional limits - AST(SGOT)/ALT(SGPT) </= 2.5 X institutional upper limit of normal - left ventricular ejection fraction within normal institutional limits - creatinine within normal institutional limits OR - creatinine clearance >/= 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal. Continued in Inclusion 7).
7) Continued from Inclusion 6). - left ventricular ejection fraction at or above institutional lower limits of normal (by echocardiogram or nuclear scan within 12 weeks of registration) - pulmonary function tests demonstrating an FEV1 >/= 1 liter and DLCO >/=50% (required within 4 weeks of registration) only if baseline CT of chest shows parenchymal lung disease, or there is a history of COPD or other pulmonary disease
8) Patients must be disease-free of prior invasive malignancies for >/= 5 years with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix. Patient with the following prior or concurrent diagnoses are eligible: lobular carcinoma in situ, contralateral ductal carcinoma in situ, or contralateral invasive ductal and/or lobular cancer (an no prior adjuvant chemotherapy for previous breast malignancy).
9) The effects of tipifarnib on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
10) Ability to understand and the willingness to sign a written informed consent document. |