Clinical trial · Interventional
Study of Letrozole Plus Tipifarnib or Placebo in the Treatment of Advanced Breast Cancer
A Randomised, Blinded, Phase 2 Study of Letrozole Plus the Farnesyl Transferase Inhibitor ZARNESTRA TM (R115777) and Letrozole Plus Placebo in the Treatment of Advanced Breast Cancer After Antiestrogen Therapy.
- 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)
The purpose of this study is to determine if the addition of tipifarnib to standard letrozole therapy leads to a better response to treatment for your cancer in comparison to letrozole plus a placebo. Tipifarnib belongs to a class of drugs called Farnesyl Transferase Inhibitors (FTI). It blocks proteins that make cancer cells grow.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ZARNESTRA, tipifarnib, R115777 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Comparisons between the two treatment groups will be made for patients who have achieve a confirmed Complete Response (CR) or Partial Response (PR).
Secondary outcomes (1)
- measure
- Effectiveness will be assessed by time to disease progression; time to treatment failure; duration of response; clinical benefit; duration of clinical benefit; survival time. The study will include evaluations of safety and tolerability.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Locally advanced, inoperable loco-regionally-recurrent, or metastatic breast cancer * Estrogen and/or progesterone positive disease * Progression of disease after antiestrogen therapy * Measurable disease * Postmenopausal * Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2. Exclusion Criteria: * Previous endocrine therapy, other than antiestrogen therapy * More than 1 prior chemotherapy regimen * Previous therapy with farnesyl transferase inhibitor * Presence of rapidly progressive, life-threatening metastases * Concomitant anticancer treatment * Other malignancy within the past 5 years * Symptomatic peripheral neuropathy.
References
Publications (1)
- DERIVEDJohnston SR, Semiglazov VF, Manikhas GM, Spaeth D, Romieu G, Dodwell DJ, Wardley AM, Neven P, Bessems A, Park YC, De Porre PM, Perez Ruixo JJ, Howes AJ. A phase II, randomized, blinded study of the farnesyltransferase inhibitor tipifarnib combined with letrozole in the treatment of advanced breast cancer after antiestrogen therapy. Breast Cancer Res Treat. 2008 Jul;110(2):327-35. doi: 10.1007/s10549-007-9726-1. Epub 2007 Sep 13. PMID 17851757