Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:18 PM
Ignite Modification Date:
2025-12-24 @ 5:18 PM
NCT ID:
NCT00100750
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed breast cancer and clinical evidence of metastatic disease
* Patients may have received any number or type of hormonal therapies, either for stage IV disease and/or as adjuvant therapy; patients may have received trastuzumab therapy
* Patients may have received up to 2 prior chemotherapy regimens as therapy for metastatic breast cancer; patients must have recovered from the myelosuppressive effects of prior chemotherapy and all toxicity must have recovered to grade less than or equal to 1
* Concomitant bisphosphonates are allowed for patients with bone metastases
* Localized radiotherapy that does not influence the single evaluable lesion is allowed prior to the initiation of therapy; patients must have recovered from the myelosuppressive effects of previous radiotherapy (at least 4 weeks)
* Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \> 20 mm with conventional techniques or as \> 10 mm with spiral computed tomography (CT) scan
* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 (Karnofsky \> 60%)
* Leukocytes \>= 3,000/mcL
* Absolute neutrophil count \>= 1,500/mcL
* Platelets \>= 100,000/mcL
* Total bilirubin within normal institutional limits
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 × institutional upper limit of normal
* Creatinine within normal institutional limits OR creatinine clearance \>= 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
* Ability to understand and the willingness to sign a written informed consent document
* There should be a four-week delay between the conclusion of radiation and the start of gemcitabine, provided the acute effects of radiation treatment have resolved
Exclusion Criteria:
* Prior therapy with farnesyltransferase inhibitor or gemcitabine for metastatic breast cancer
* Patients with leptomeningeal disease and/or brain metastasis
* Patients with symptomatic lymphangitic pulmonary metastases
* Patients with peripheral neuropathy greater than or equal to grade 2
* No history of concomitant malignancy except for non-melanoma skin cancer or cervical cancer in situ or other malignancy treated curatively and no evidence of disease for at least five years
* Patients who have had chemotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
* Patients may not be receiving any other investigational agents
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to tipifarnib (R115777), or imidazole derivatives
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Human immunodeficiency virus (HIV)-positive patients receiving combination anti-retroviral therapy are excluded from the study
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00100750
Study Brief:
Protocol Section:
NCT00100750