Clinical trial NCT00082810 (phase 2, status: completed)
Conditions: estrogen receptor-positive breast cancer, recurrent breast cancer, stage iiib breast cancer, stage iiic breast cancer, stage iv breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60, C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60, C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60, C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60, C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: fulvestrant, tipifarnib
SMILES: [H][C@@]12CC[C@H](O)[C@@]1(C)CC[C@]1([H])C3=CC=C(O)C=C3C[C@@H](CCCCCCCCCS(=O)CCCC(F)(F)C(F)(F)F)[C@@]21[H], CN1C=NC=C1[C@@](N)(C1=CC=C(Cl)C=C1)C1=CC2=C(C=C1)N(C)C(=O)C=C2C1=CC(Cl)=CC=C1
Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically or cytologically confirmed adenocarcinoma of the
             breast

          -  Patients must be postmenopausal

          -  Patients must have stage IV disease or inoperable locally advanced disease

          -  Patients must have ER- and/or PR-positive disease as determined by their local
             pathology laboratory

          -  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 CT scan; all sites of
             disease should be noted and followed

          -  Prior hormonal therapy as adjuvant therapy and/or for metastatic disease is permitted;
             patients previously treated with two or more prior doses of fulvestrant are not
             eligible; patients who have received one prior dose of fulvestrant within 28 days are
             eligible so long as they meet other eligibility criteria

          -  Patients must have ECOG performance status 0-2 (Karnofsky >= 60%)

          -  Patients must have life expectancy of greater than 3 months

          -  Leukocytes >= 3,000/uL

          -  Absolute neutrophil count >= 1,500/uL

          -  Platelets >= 100,000/uL

          -  Total bilirubin =< 2 mg/dL

          -  AST(SGOT)/ALT(SGPT) =< 2.5 x institutional upper limit of normal

          -  Creatinine less than or equal to 1.5 times the institutional upper limits of normal

          -  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

          -  Patients must have the ability to understand and the willingness to sign a written
             informed consent document

          -  Patients who have had previous therapy with farnesyltransferase inhibitor

        Exclusion Criteria:

          -  Patients who have had radiotherapy within 4 weeks prior to entering the study or those
             who have not recovered from adverse events due to agents administered more than 4
             weeks earlier; patients who have had prior chemotherapy for metastatic disease are not
             eligible; prior adjuvant or neoadjuvant chemotherapy is allowed

          -  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, Zarnestra™) or other agents used in the study
             (e.g., imidazoles, quinolones)

          -  Presence of rapidly progressive, life-threatening metastases; this includes patients
             with extensive hepatic involvement (> 50% of the liver involved), symptomatic
             lymphangitic metastases, or brain or leptomeningeal involvement

          -  Concomitant anticancer treatment with the following exceptions: (1) bisphosphonates
             for bone metastases, (2) a GnRH analog is permitted if the patient had progressive
             disease on a GnRH analog plus a SERM or an AI; the GnRH analog may continue but the
             SERM or AI must be discontinued

          -  Grade 2 or more peripheral neuropathy

          -  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

          -  HIV-positive patients receiving combination anti-retroviral therapy are excluded from
             the study because of possible pharmacokinetic interactions with tipifarnib or other
             agents administered during the study.; appropriate studies will be undertaken in
             patients receiving combination anti-retroviral therapy when indicated