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

NCT00873808 | Withdrawn DMC

• 3 other identifiers: CDR0000614118S0307AU10CA032102
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

breast cancer

Outcome Measures

Primary Outcomes (1)

• Change in bone quality after long-term high-dose bisphosphonates as measured by histomorphometry, mineralization density, micro-computed tomography, and biomechanics of bone biopsy samples

Secondary Outcomes (2)

• Comparison of the potency of bisphosphonates as measured by changes in bone quality in each treatment group

• Correlations among measures of bone formation, structure, mineralization, and strength

Interventions

clodronate disodium DRUG

demeclocycline hydrochloride DRUG

ibandronate sodium DRUG

tetracycline hydrochloride DRUG

zoledronic acid DRUG

laboratory biomarker analysis OTHER

adjuvant therapy PROCEDURE

computed tomography PROCEDURE

dual x-ray absorptiometry PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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

Sponsors & Collaborators

• SWOG Cancer Research Network: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University Cancer Center at University of Washington Medical Center

Seattle, Washington, 98195-6043, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Clodronic Acid; Demeclocycline; Ibandronic Acid; Tetracycline; Zoledronic Acid; Chemotherapy, Adjuvant; Absorptiometry, Photon

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Combined Modality Therapy; Therapeutics; Drug Therapy; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Densitometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Dawn Hershman, MD

  Herbert Irving Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: observational
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2009
• First Posted: April 2, 2009
• Study Start: October 1, 2008
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: April 10, 2013

Record last verified: 2013-04

Locations

US (1)