Clinical trial · Interventional
Perifosine in Treating Patients With Recurrent, Refractory, Locally Advanced, or Metastatic Breast Cancer
A Phase 2 Study Of Perifosine In Metastatic Or Advanced Breast Cancer
NCT00054145CI-TRIAL-00018622completedPhase 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: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of perifosine in treating patients who have recurrent, refractory, locally advanced, or 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| perifosine | Drug | Perifosine | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed breast cancer * Recurrent or refractory, locally advanced or metastatic disease * At least 1 unidimensionally measurable lesion * At least 20 mm by conventional techniques OR 10 mm by spiral CT scan * Previously irradiated lesions are not considered measurable unless they have demonstrated progression before study entry * No measurable disease limited to bone lesions * No known brain metastases * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * 18 and over Sex * Male or female Menopausal status * Not specified Performance status * ECOG 0-2 OR * Karnofsky 60-100% Life expectancy * More than 3 months Hematopoietic * WBC at least 3,000/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * No history of hemolytic disorder Hepatic * Bilirubin no greater than 1.25 times upper limit of normal (ULN) * AST/ALT no greater than 2.5 times ULN (5 times ULN if liver metastases present) Renal * Creatinine normal OR * Creatinine clearance at least 60 mL/min Cardiovascular * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia * No evidence of cardiac dysfunction Gastrointestinal * No history of biliary flow obstruction * No abnormalities of the gastrointestinal tract that would preclude study drug absorption * No active peptic ulcer disease Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No ongoing or active infection * No poorly controlled diabetes mellitus * No other uncontrolled illness * No prior allergic reactions to compounds of similar chemical or biological composition to perifosine * No psychiatric illness or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No more than 2 prior lines of chemotherapy for advanced disease, excluding adjuvant chemotherapy * Prior adjuvant chemotherapy allowed * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered Endocrine therapy * At least 4 weeks since prior endocrine therapy * Multiple lines of endocrine therapy for advanced disease allowed Radiotherapy * At least 4 weeks since prior radiotherapy and recovered * Prior radiotherapy for metastatic disease allowed Surgery * No prior major gastric surgery * Prior surgery, including for metastatic disease, allowed Other * No other concurrent anticancer or investigational agents * No concurrent antiretroviral therapy in HIV-positive patients * Concurrent bisphosphonates allowed
References
Publications (1)
- RESULTLeighl NB, Dent S, Clemons M, Vandenberg TA, Tozer R, Warr DG, Crump RM, Hedley D, Pond GR, Dancey JE, Moore MJ. A Phase 2 study of perifosine in advanced or metastatic breast cancer. Breast Cancer Res Treat. 2008 Mar;108(1):87-92. doi: 10.1007/s10549-007-9584-x. Epub 2007 Apr 26. PMID 17458693