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

ETOP IBCSG Partners Foundation

Status and phase: Terminated; Phase 3

Conditions: Osteoporosis; Breast Cancer

Treatments: Procedure: spectroscopy

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT00899288

CDR0000482403

IBCSG-1-98-FPS (Other Identifier)

IBCSG-18-98-FPS (Other Identifier)

EU-20625

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 4 patient groups

tamoxifen and no bone fracture

Experimental group

Description:

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

Treatment:

Procedure: spectroscopy

Letrozole and no bone fracture

Experimental group

Description:

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

Treatment:

Procedure: spectroscopy

Tamoxifen and bone fracture

Experimental group

Description:

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

Treatment:

Procedure: spectroscopy

Letrozole and bone fracture

Experimental group

Description:

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

Treatment:

Procedure: spectroscopy