Back to results

Fingernails in Evaluating Bone Health in Postmenopausal Women With Breast Cancer Undergoing Hormone Therapy on Clinical Trial IBCSG-1-98

Primary Purpose

Breast Cancer, Osteoporosis

Status

Terminated

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

spectroscopy

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring osteoporosis, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

tamoxifen and no bone fracture

Letrozole and no bone fracture

Tamoxifen and bone fracture

Letrozole and bone fracture

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00899288

First Posted

May 9, 2009

Last Updated

July 26, 2012

Sponsor

ETOP IBCSG Partners Foundation

1. Study Identification

Unique Protocol Identification Number

NCT00899288

Brief Title

Fingernails in Evaluating Bone Health in Postmenopausal Women With Breast Cancer Undergoing Hormone Therapy on Clinical Trial IBCSG-1-98

Official Title

Investigating the Chemical Properties of Fingernails to Determine the Efficacy of Nail Structure for Evaluating Bone Fragility

Study Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Terminated

Why Stopped

Insufficient accrual

Study Start Date

April 2005 (undefined)

Primary Completion Date

July 2007 (Actual)

Study Completion Date

July 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ETOP IBCSG Partners Foundation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

OBJECTIVES: Primary Compare the effects of tamoxifen vs letrozole on the chemical properties of fingernails by Raman spectroscopy in postmenopausal women with breast cancer undergoing adjuvant hormonal therapy on protocol IBCSG-1-98. Determine the efficacy of nail structure for evaluating bone fragility. Secondary Compare fingernail assessments in patients who have had a bone fracture vs those who have not. Determine the natural variation in chemical (Raman spectroscopy) properties of 2 fingernails sourced at 1 appointment from the same donor. Evaluate the effect of further drug treatment (after 6 months) on the chemical properties of fingernails. OUTLINE: This is a single-blind, multicenter, pilot study. Patients are stratified according to treatment on protocol IBCSG-1-98 (tamoxifen vs letrozole) and bone fracture (yes vs no). Fingernail clippings are collected at baseline and 6 months later. Fingernail clippings are examined by Raman spectroscopy. PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer, Osteoporosis

Keywords

osteoporosis, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

tamoxifen and no bone fracture

Arm Type

Experimental

Arm Description

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

Arm Title

Letrozole and no bone fracture

Arm Type

Experimental

Arm Description

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

Arm Title

Tamoxifen and bone fracture

Arm Type

Experimental

Arm Description

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

Arm Title

Letrozole and bone fracture

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

spectroscopy

Intervention Description

Nails will be chemically characterized using Raman spectroscopy.

Primary Outcome Measure Information:

Title

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

Time Frame

At baseline and 6 months after inclusion in the trial

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark Towler, MD

Organizational Affiliation

Materials & Surface Science Institute at the University of Limerick

Official's Role

Study Chair

12. IPD Sharing Statement

Learn more about this trial

Fingernails in Evaluating Bone Health in Postmenopausal Women With Breast Cancer Undergoing Hormone Therapy on Clinical Trial IBCSG-1-98

We'll reach out to this number within 24 hrs