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CompletedNCT00054145Updated Jul 23, 2015

Perifosine in Treating Patients With Recurrent, Refractory, Locally Advanced, or Metastatic Breast Cancer

A Phase 2 interventional study of perifosine in Breast Cancer, sponsored by University Health Network, Toronto. Completed at 4 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-07-23.

Sponsored by University Health Network, Toronto · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

OBJECTIVES:

  • Determine the objective tumor response rate in patients with recurrent or refractory, locally advanced or metastatic breast cancer treated with perifosine.
  • Determine the toxicity of this drug in these patients.
  • Determine the stable disease rate, time to disease progression, objective response duration, and duration of stable disease in patients treated with this drug.
  • Correlate potential endpoints, including phosphorylated ERK, PKB, and SAPK, phosphorylated PKC alpha, beta, and gamma isoforms, p21 \^WAF1; and activated capase-3 in tumor biopsies, with clinical outcome in patients treated with this drug.

OUTLINE: This is an open-label, multicenter study.

Patients receive a loading dose of oral perifosine on days 1 and 2 and once daily on days 3-21 during course 1. Patients receive oral perifosine once daily on days 1-21 in each subsequent course. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) may receive 2 additional courses beyond the CR.

PROJECTED ACCRUAL: A total of 18-35 patients will be accrued for this study within 6-12 months.

02

Conditions studied

  • Breast Cancer

Keywords

  • male breast cancer
  • recurrent breast cancer
  • stage IV breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
03

In context

Breast Neoplasms

12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.

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Lead sponsor

University Health Network, Toronto is the lead sponsor of 1,432 studies on the registry; 292 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Masking
None (open label)

Interventions

06

Study locations

4 sites
  • Margaret and Charles Juravinski Cancer Centre
    Hamilton, Ontario L8V 5C2, Canada
  • Cancer Care Ontario-London Regional Cancer Centre
    London, Ontario N6A 4L6, Canada
  • Ottawa Regional Cancer Centre
    Ottawa, Ontario K1H 1C4, Canada
  • Princess Margaret Hospital
    Toronto, Ontario M5G 2M9, Canada
07

References and documents

Publications

  • Leighl 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. PubMed 17458693 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 23, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00054145
Responsible party
Sponsor
First posted
Feb 6, 2003
Start date
Jun 2003
Primary completion
Apr 2007
Last update
Jul 23, 2015

Study contacts

Natasha Leighl, MD, FRCPC
study chair · Princess Margaret Hospital, Canada
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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