None listed
Conditions
Interventions
Group 1 Type of group
Lonafamib 200 mg PC BID + Anastrozol 1mg PO QD
Group name:Group 2 Type of group
Racebo PO BID + Anastrozol 1mg PO QD
Sponsors
SCHERING PLOUGH RESEARCH INSTITUTE,
Eligibility
Inclusion criteria
Inclusion criteria: • Postmenopausal women who have histologically confirmed breast cancer with the following characteristics: (a) positive tumor for estrogen and / or progesterone receptors; (b) presence of distant metastatic disease (Stage 4 according to the definition of the American Joint Committee on Cancer Staging System for Breast Cancer, Journal of Clinical Oncology 2002; 20: 3628-3636). • Women who have received a course of adjuvant hormone therapy (tamoxifen or aromatase inhibitor) or who have not received previous treatment. (Women treated with hormone therapy must have responded to previous adjuvant hormone therapy, as indicated by [a] lack of relapse for at least 2 years while receiving adjuvant hormone therapy, and [b] lack of relapse for at least 12 months. months after completing adjuvant hormone therapy). • Subjects may have received adjuvant chemotherapy treatment as long as: (a) they have not received more than 6 cycles of chemotherapy, and (b) the subject has not received chemotherapy after completing adjuvant hormone therapy. In the case of subjects who received adjuvant chemotherapy only, there should be no relapse of the disease for at least 12 months after completing chemotherapy. • Subjects who are taking bisphosphonates can participate in the study as long as they have started bisphosphonate therapy two weeks before randomization and have maintained a stable dose, and remain with a stable dose of bisphosphonates throughout the course of treatment . You can not start a treatment with bisphosphonates during the study. • Subjects with measurable disease (masses with clearly defined margins in the radiological images and with at least one diameter ^ 0 mm [> 10 mm if it is helical CT]) or evaluable disease (masses with margins not clearly defined in the images) radiological or without diameter ^ 0 mm). The type of tomograph is important for the specification of the measurable lesion of minimum size and the appropriate cut thickness. In the case of helical computed tomographs, the minimum size of a specific lesion at the beginning can be 10 mm, as long as the images are reconstructed contiguously at 5 mm intervals. In the case of conventional computed tomographs, the minimum size of a specific lesion at the beginning can be 20 mm using contiguous 10 mm intervals. Subjects with bone disease can only participate if the disease is evaluable • Subjects with general status on the ECOG Scale from 0 to 1. • Subjects with sufficient bone marrow reserve, as indicated below: a. Neutrophils> 1.5x10 9 / L b. Platelet count> 100x10 9 / L c. Hemoglobin> 10.0 gm / dL Subjects with hepatic staining as indicated below; to. Bilirubin <1.5 x ULN b. ASI and ALT <2 x ULN c. Alkaline Phosphatase <.5 x ULN. • Subjects with renal staining as indicated below: a. Serum creatinine <1.5 x ULN
Exclusion criteria
Exclusion criteria: • Subjects with previous hormone therapy (except an aromatase inhibitor or tamoxifen, as indicated in Inclusion Criterion No. 2 [see Table 3]) or prior chemotherapy except one single course of adjuvant chemotherapy as described in the Criterion Inclusion N 3 [see Table 3]) for metastatic disease Prior radiotherapy is allowed. • Subjects with cerebral metastases or extensive visceral disease, including extensive hepatic involvement or pulmonary lymphatic spread of the tumor. • Subjects with previous treatment with farnesyl transferase inhibitors. • Subjects that at the investigator´s discretion have an estimated survival of less than 3 months from the beginning of the study. • Subjects who are in a situation or present a condition that, in the opinion of the Investigator, could interfere with their optimal participation in the study. • Subjects who have used a drug in the research phase within 30 days prior to entering the study. • Subjects who are participating in any other clinical study. • Subjects that are part of the personnel directly involved in this study. • Subjects who are relatives of the research study staff. • Subjects with confirmation or suspicion of hypersensitivity to any of the excipients of the formulation of lonafarnib (Povidone, Poloxamer 188, croscarmellose sodium, silicon dioxide and magnesium stearate).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:As determined by the evaluation of central radiology. Measure:Survival without progression Timepoints:After treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:According to the criteria of evaluation of response in solid tumors [RECIST] slightly modified Measure:Objective response rate Timepoints:After treatment ; Outcome name:Clinical evaluation of signs and symptoms Measure:Duration of the response Timepoints:During treatment ; Outcome name:Clinical evaluation of signs and symptoms Measure:Overall survival Timepoints:After treatment | — |
Contacts
Public ContactJorge Timoteo
SCHERING PLOUGH DEL PERU S.A.
Outcome results
None listed