NCT00437359

Brief Summary

To investigate the benefit of postoperative adjuvant therapy using sequential administration of the hormone, toremifene citrate (TOR) or anastrozole (ANA), after chemotherapy in breast cancer.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2007

Longer than P75 for phase_2

Geographic Reach
1 country

7 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 21, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2007

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

March 30, 2012

Status Verified

March 1, 2012

Enrollment Period

10 years

First QC Date

February 18, 2007

Last Update Submit

March 28, 2012

Conditions

Breast Neoplasms

Keywords

Breast NeoplasmsDrug Therapy

Outcome Measures

Primary Outcomes (1)

  • Recurrence-free rate

    The observation period is designated as 10 years from the commencement of treatment.

Secondary Outcomes (6)

  • Survival rate

    The observation period is designated as 10 years from the commencement of treatment.

  • Drug adverse events

    The observation period is designated as 10 years from the commencement of treatment.

  • Bone metabolism markers (BAP, NTx)

    Pretreatment, and post-treatment at 3, 6, 12, and 24 months.

  • BMD (DXA method): Lumbar vertebrae, femoral neck

    Pretreatment, and post-treatment at 12 months and 24 months.

  • Laboratory values of lipid metabolism (TC, LDL, HDL, Lp(a), TG)

    Pretreatment, and post-treatment at 3, 6, 12, and 24 months.

  • +1 more secondary outcomes

Study Arms (2)

Fareston

OTHER

Toremifene citrate: 40-mg tablets by mouth once daily.

Drug: Toremifene citrate

Arimidex

OTHER

Anastrozole: 1-mg tablets by mouth once daily.

Drug: Anastrozole

Interventions

Toremifene citrateDRUG

Toremifene citrate: 40-mg tablets by mouth once daily.

Also known as: Fareston
Fareston
AnastrozoleDRUG

Anastrozole: 1-mg tablets by mouth once daily.

Also known as: Arimidex
Arimidex

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Written consent obtained for study participation.
  • Breast cancer diagnosed histologically with a breast removed or preserved.
  • Positive ER or PR testing by immunohistochemistry (IHC), enzyme immunoassay (EIA) and who meet the criteria of each institution.
  • HER2 evaluation.
  • Patient Status (PS): 0 or 1.
  • Fully functional heart, liver, kidneys, and bone marrow.
  • More than one year since last menstruation or tested postmenopausal from estradiol (E2) and follicle-stimulating hormone (FSH) levels based on evaluation standard of each institution.
  • Expected to live for at least three months (or longer) after study commencement.

You may not qualify if:

  • Pregnant or breast feeding.
  • Bilateral or inflammatory breast cancer.
  • Multiple cancers.
  • Life-threatening metastases.
  • History of serious hypersensitivity.
  • Judged ineligible for the study by the study doctor.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Kyushu Central Hospital

Fukuoka, 815-8588, Japan

Location

Kansai Medical University Hirakata Hospital

Hirakata, 573-1191, Japan

Location

Hirosaki University Hospital

Hirosaki, 036-8563, Japan

Location

Hiroshima University Hospital

Hiroshima, 734-8551, Japan

Location

Shinyahashiradai Hospital

Matsudo, 270-2253, Japan

Location

The University of Tokyo Hospital

Tokyo, 113-8655, Japan

Location

Nagumo Clinic

Tokyo, 141-0032, Japan

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

ToremifeneAnastrozole

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TamoxifenStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsNitrilesTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Satoru Iwase, MD

    Department of Palliative Medicine, The University of Tokyo Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2007

First Posted

February 21, 2007

Study Start

May 1, 2007

Primary Completion

May 1, 2017

Study Completion

May 1, 2020

Last Updated

March 30, 2012

Record last verified: 2012-03

Locations

JP(7)