Stage IV Breast Cancer Clinical Trial
Official title:
A Phase II Trial of Capecitabine in Combination With the Farnesyltransferase Inhibitor, R115777 (Tipifarnib, Zarnestra) in Patients With Metastatic Breast Cancer
This phase II trial is studying how well giving capecitabine together with tipifarnib works in treating women with taxane-resistant metastatic breast cancer. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Giving capecitabine together with tipifarnib may kill more tumor cells
PRIMARY OBJECTIVES:
I. The primary objective of this study is to determine the response rate in patients with
taxane-resistant metastatic breast cancer treated with capecitabine plus tipifarnib.
SECONDARY OBJECTIVES:
I. To evaluate toxicity in patients with taxane-resistant metastatic breast cancer treated
with capecitabine plus tipifarnib.
II. To evaluate progression free survival, time to treatment failure, and overall survival
in patients with taxane-resistant metastatic breast cancer treated with capecitabine plus
tipifarnib.
OUTLINE: This is a multicenter study.
Patients receive oral tipifarnib twice daily and oral capecitabine twice daily on days 1-14.
Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients achieving a complete response (CR) receive 4 additional courses beyond
documentation of CR.
Patients are followed every 3 months for 2 years and then every 6 months for 1 year.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01987726 -
Comprehensive Gene Sequencing in Guiding Treatment Recommendations Patients With Metastatic or Recurrent Solid Tumors
|
||
| Completed |
NCT01881230 -
Evaluate Risk/Benefit of Nab Paclitaxel in Combination With Gemcitabine and Carboplatin Compared to Gemcitabine and Carboplatin in Triple Negative Metastatic Breast Cancer (or Metastatic Triple Negative Breast Cancer)
|
Phase 2/Phase 3 | |
| Terminated |
NCT01918306 -
GDC-0941 and Cisplatin in Treating Patients With Androgen Receptor-Negative Triple Negative Metastatic Breast Cancer
|
Phase 1/Phase 2 | |
| Terminated |
NCT01705340 -
Akt Inhibitor MK2206, Lapatinib Ditosylate, and Trastuzumab in Treating Patients With Locally Advanced or Metastatic HER2-Positive Breast , Gastric, or Gastroesophageal Cancer That Cannot Be Removed By Surgery
|
Phase 1 | |
| Terminated |
NCT01222377 -
Endoscopic Breast Surgery in Treating Patients With Breast Cancer
|
N/A | |
| Completed |
NCT00602043 -
F-18 16 Alpha-Fluoroestradiol-Labeled Positron Emission Tomography in Predicting Response to First-Line Hormone Therapy in Patients With Stage IV Breast Cancer
|
Phase 2 | |
| Completed |
NCT00096109 -
Tanespimycin in Treating Women With Refractory Locally Advanced or Metastatic Breast Cancer
|
Phase 2 | |
| Completed |
NCT00244881 -
A Phase II Study of AZD2171 in Breast Cancer Stage IV (10006202)
|
Phase 2 | |
| Completed |
NCT00425672 -
ONTAK® in Treating Patients With Advanced Breast Cancer That Did Not Respond to Previous Treatment
|
Phase 1/Phase 2 | |
| Completed |
NCT00100750 -
Tipifarnib and Gemcitabine Hydrochloride in Treating Women With Metastatic Breast Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT00096434 -
Sorafenib in Treating Patients With Metastatic Breast Cancer
|
Phase 2 | |
| Completed |
NCT00057941 -
Anastrozole and ZD1839 Compared With Fulvestrant and ZD1839 in Postmenopausal Women w/ Metastatic Breast Cancer
|
Phase 2 | |
| Terminated |
NCT02892734 -
Ipilimumab and Nivolumab in Treating Patients With Recurrent Stage IV HER2 Negative Inflammatory Breast Cancer
|
Phase 2 | |
| Recruiting |
NCT03213041 -
Pembrolizumab and Carboplatin in Treating Patients With Circulating Tumor Cells Positive Metastatic Breast Cancer
|
Phase 2 | |
| Completed |
NCT02015559 -
Mucoadhesive Oral Wound Rinse in Preventing and Treating Stomatitis in Patients With ER- or PR-Positive Metastatic or Locally Recurrent Breast Cancer That Cannot be Removed by Surgery Receiving Everolimus
|
Phase 2 | |
| Completed |
NCT02728596 -
S1415CD, Trial Assessing CSF Prescribing Effectiveness and Risk (TrACER)
|
N/A | |
| Completed |
NCT03364348 -
4-1BB Agonist Monoclonal Antibody PF-05082566 With Trastuzumab Emtansine or Trastuzumab in Treating Patients With Advanced HER2-Positive Breast Cancer
|
Phase 1 | |
| Completed |
NCT02897375 -
Palbociclib With Cisplatin or Carboplatin in Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT01672684 -
Phase I: At-Home Support for Rural Women Using Group Video Calling
|
Phase 1 | |
| Terminated |
NCT01149356 -
RO4929097 And Exemestane in Treating Pre- and Postmenopausal Patients With Advanced or Metastatic Breast Cancer
|
Phase 1 |