S0307A, Long-Term Bone Quality in Women With Breast Cancer Enrolled on Clinical Trial SWOG-S0307

NCT ID: NCT00873808

Last Updated: 2013-04-10

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2010-02-28

Brief Summary

RATIONALE: Gathering information over time from imaging and laboratory tests of women receiving bisphosphonates for breast cancer may help doctors learn more about long-term bone quality and plan the best treatment. Tetracycline hydrochloride and demeclocycline hydrochloride can mark the new growth of the bone, so it may be seen better under a microscope.

PURPOSE: This clinical trial is studying long-term bone quality in women with breast cancer enrolled on clinical trial SWOG-S0307.

Detailed Description

OBJECTIVES:

• To assess if long-term high-dose bisphosphonates alter bone quality as measured by change in the histomorphometry of bone biopsies after tetracycline hydrochloride labeling to calculate eroded and osteoid surfaces, mineralization surface, bone formation rate, wall width, and activation frequency.
• To assess if long-term high-dose bisphosphonates alter bone quality as measured by change in the backscattered electron imaging of bone to measure average mineralization density as well as distribution of density values.
• To assess if long-term high-dose bisphosphonates alter bone quality as measured by change in the micro-computed tomography of bone biopsy specimens to measure bone structure, including bone volume, connectivity, trabecular width, and cortical width.
• To assess if long-term high-dose bisphosphonates alter bone quality as measured by change in the biomechanical testing of bone biopsy samples loaded in compression to measure stress-strain relationships, including Young's modulus, yield point, ultimate strain, and work to failure (toughness).
• To characterize bone using classical, non-invasive techniques (i.e., measurement of bone mineral density of spine and hip using dual energy x-ray absorptiometry and analysis of serum biochemical markers of bone formation [i.e., bone specific alkaline phosphatase] and resorption [i.e., N-telopeptide]) after long-term, high-dose bisphosphonates.

OUTLINE: This is a multicenter study.

At baseline (prior to initiating bisphosphonate therapy on SWOG-S0307), patients receive oral tetracycline hydrochloride twice daily on days 1 and 2 and oral demeclocycline hydrochloride twice daily on days 11 and 12. Patients undergo a tetracycline hydrochloride-labeled bone biopsy from the anterior ilium on day 14. At 36 months (for patients who have completed bisphosphonate therapy) or after 30 months of concurrent bisphosphonate therapy, patients receive oral demeclocycline twice daily on days 1 and 2 and oral tetracycline hydrochloride twice daily on days 11 and 12. Patients undergo a demeclocycline hydrochloride-labeled bone biopsy from the anterior ilium on day 14.

Patients undergo dual energy x-ray absorptiometry measurements of the hip and spine at the time of biopsy or within the next 10 weeks. Blood samples are collected for analysis of bone specific alkaline phosphatase and N-telopeptide before and after treatment on the clinical trial.

After completion of study treatment, patients are followed for up to 10 years.

Conditions

Breast Cancer

Interventions

clodronate disodium

Intervention Type: DRUG

demeclocycline hydrochloride

Intervention Type: DRUG

ibandronate sodium

Intervention Type: DRUG

tetracycline hydrochloride

Intervention Type: DRUG

zoledronic acid

Intervention Type: DRUG

laboratory biomarker analysis

Intervention Type: OTHER

adjuvant therapy

Intervention Type: PROCEDURE

computed tomography

Intervention Type: PROCEDURE

dual x-ray absorptiometry

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Concurrently enrolled on clinical trial SWOG-S0307 and receiving bisphosphonates as adjuvant therapy for primary breast cancer
• No rickets, osteogenesis imperfecta, osteosclerosis, or osteomalacia
• No bone fracture since the age of 21 years unless it was caused by trauma
• Hormone receptor status not specified

PATIENT CHARACTERISTICS:

• Menopausal status not specified
• Weight < 300 lbs
• No hyperparathyroidism
• No serious concurrent or prior anorexia nervosa diagnosed by a physician and causing abnormal menstruation
• No history of hypersensitivity to tetracycline or demeclocycline

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• More than 10 years since prior prednisone at a dose above 5 mg/day for ≥ 3 months
• No prior prednisone before diagnosis of breast cancer
• No prior bisphosphonate therapy
• No concurrent anticonvulsant medications

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

SWOG Cancer Research Network

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dawn Hershman, MD

Role: STUDY_CHAIR

Herbert Irving Comprehensive Cancer Center

Locations

University Cancer Center at University of Washington Medical Center

Seattle, Washington, United States

Countries

United States

Other Identifiers

S0307A

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA032102

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDR0000614118

Identifier Type: -

Identifier Source: org_study_id