NCT00899288

Brief Summary

RATIONALE: Studying samples of fingernails in the laboratory from patients with breast cancer may help in evaluating bone health in postmenopausal women undergoing hormone therapy for breast cancer. PURPOSE: This laboratory study is examining fingernails as a way of evaluating bone health in postmenopausal women with breast cancer undergoing hormone therapy on clinical trial IBCSG-1-98.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at below P25 for phase_3 breast-cancer

Timeline
Completed

Started Apr 2005

Shorter than P25 for phase_3 breast-cancer

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

Study Start

First participant enrolled

April 1, 2005

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
Last Updated

July 27, 2012

Status Verified

July 1, 2012

Enrollment Period

2.2 years

First QC Date

May 9, 2009

Last Update Submit

July 26, 2012

Conditions

Breast CancerOsteoporosis

Keywords

osteoporosisstage I breast cancerstage II breast cancerstage IIIA breast cancer

Outcome Measures

Primary Outcomes (1)

  • Determination of bone health using fingernail assessments at baseline and 6 months

    At baseline and 6 months after inclusion in the trial

Study Arms (4)

tamoxifen and no bone fracture

EXPERIMENTAL

Patients randomized to Arm A of Study BIG 1-98 (tamoxifen for 5 years) who have not had a bone fracture.

Procedure: spectroscopy

Letrozole and no bone fracture

EXPERIMENTAL

Patients randomized to Arm B of Study BIG 1-98 (letrozole for 5 years) who have not had a bone fracture.

Procedure: spectroscopy

Tamoxifen and bone fracture

EXPERIMENTAL

Patients randomized to Arm A of Study BIG 1-98 (tamoxifen for 5 years) who have had a bone fracture.

Procedure: spectroscopy

Letrozole and bone fracture

EXPERIMENTAL

Patients randomized to Arm B of Study BIG 1-98 (letrozole for 5 years) who have had a bone fracture.

Procedure: spectroscopy

Interventions

spectroscopyPROCEDURE

Nails will be chemically characterized using Raman spectroscopy.

Letrozole and bone fractureLetrozole and no bone fractureTamoxifen and bone fracturetamoxifen and no bone fracture

Eligibility Criteria

Age30 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Enrolled on protocol IBCSG-1-98 * Currently receiving (i.e., have not yet completed) 5 years of treatment with tamoxifen or letrozole and expected to receive ≥ 6 months of additional treatment on protocol IBCSG-1-98 * No recurrent breast cancer or second primary cancer * No known bone disease (including osteomalacia or osteogenesis imperfecta) * Hormone receptor status * Estrogen and/or progesterone receptor positive tumor PATIENT CHARACTERISTICS: * Female * Postmenopausal * No uncontrolled thyroid or parathyroid disease, Cushing's disease, or other pituitary diseases * No malabsorption syndrome or clinically relevant vitamin D deficiency PRIOR CONCURRENT THERAPY: * See Disease Characteristics * More than 1 year since prior and no concurrent anticonvulsants * More than 6 months since prior and no concurrent corticosteroids at doses \> the equivalent of 5 mg/day of prednisone for \> 2 weeks total * No prior or concurrent sodium fluoride at daily doses ≥ 5 mg/day for \> 1 month * More than 12 months since prior and no concurrent anabolic steroids * More than 6 months since any prior drug for the prevention of osteoporosis (excluding calcium or cholecalciferol \[vitamin D\]) * Concurrent warfarin allowed provided duration of treatment is no more than 4 weeks

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast NeoplasmsOsteoporosis

Interventions

Spectrum Analysis

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Chemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Mark Towler, MD

    Materials & Surface Science Institute at the University of Limerick

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

April 1, 2005

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

July 27, 2012

Record last verified: 2012-07