Clinical trial · Interventional
Tipifarnib Plus Tamoxifen in Treating Women With Metastatic Breast Cancer
A Phase II Trial Of Tipifarnib (R15777, ZARNESTRA) In Combination With Tamoxifen In Subjects With Metastatic Breast Cancer
NCT00052728CI-TRIAL-00010790completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Tamoxifen may fight breast cancer by blocking the use of estrogen. Combining tipifarnib with tamoxifen may be effective treatment for metastatic breast cancer. PURPOSE: This phase II trial is studying how well giving tipifarnib together with tamoxifen works in treating women with metastatic breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| tamoxifen citrate | Drug | Tamoxifen | ALIAS |
| tipifarnib | Drug | Tipifarnib | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of metastatic (stage IV) breast cancer
* Evidence of disease progression
* Measurable disease
* Must have been previously treated with at least 1 hormonal therapy with either an aromatase inhibitor or an estrogen receptor (ER)-modulating drug in the adjuvant or metastatic setting and meets 1 of the following criteria:
* Hormone-responsive disease:
* Stable disease (no recurrence or progression for at least 6 months)
* Objective response
* Hormone-nonresponsive disease:
* No stable disease
* No objective response
* Previously treated CNS disease allowed provided patient has a life expectancy of at least 3 months (phase I patients) (Phase I closed to accrual effective 10/23/2003)
* No CNS metastases (phase II patients)
* Hormone receptor status:
* ER and/or progesterone receptor positive
* NOTE: As few as 1% positive cells considered positive
PATIENT CHARACTERISTICS:
Age
* 18 and over
Sex
* Female
Menopausal status
* Not specified
Performance status
* Zubrod 0-1
Life expectancy
* See Disease Characteristics
Hematopoietic
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic
* Bilirubin no greater than 2.0 mg/dL (unless evidence of Gilbert's disease)
* SGOT and SGPT less than 3 times upper limit of normal (unless liver involvement by tumor)
Renal
* Creatinine no greater than 1.5 mg/dL
Other
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective nonhormonal contraception during and for 2 months after study participation
* No medical or psychiatric condition that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No more than 2 prior chemotherapy regimens for metastatic disease (phase II patients)
* No limitations on prior neoadjuvant or adjuvant regimens
* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
Endocrine therapy
* See Disease Characteristics
* At least 6 months since prior tamoxifen
* Concurrent stable dose of steroids allowed (phase I patients) (Phase I closed to accrual effective 10/23/2003)
Radiotherapy
* No concurrent radiotherapy
Surgery
* Concurrent surgery allowed provided the need for surgery is not due to disease progression
Other
* Recovered from all prior therapy
* No prior warfarin
* No concurrent cytochrome p450-inducing anti-convulsants
* No other concurrent anticancer therapies
* Concurrent bisphosphonates for bone metastases allowedReferences
Publications (2)
- RESULTLebowitz PF, Eng-Wong J, Widemann BC, Balis FM, Jayaprakash N, Chow C, Clark G, Gantz SB, Venzon D, Zujewski J. A phase I trial and pharmacokinetic study of tipifarnib, a farnesyltransferase inhibitor, and tamoxifen in metastatic breast cancer. Clin Cancer Res. 2005 Feb 1;11(3):1247-52. PMID 15709195
- RESULTLebowitz PF, Eng-Wong J, Balis F, et al.: A phase I trial of tipifarnib, a farnesyltransferase inhibitor, and tamoxifen in hormone-receptor positive metastatic breast cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 22 (Suppl 14): A-644, 38s, 2004.