|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | NCIC Clinical Trials Group |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00688246 |
Purpose
RATIONALE: Learning about the effect of exemestane on bone mineral density in postmenopausal women at increased risk of breast cancer may help plan treatment, decrease the risk of broken bones, and help patients live more comfortably.
PURPOSE: This research study is measuring bone mineral density in postmenopausal women at increased risk of developing breast cancer who are receiving exemestane on clinical trial CAN-NCIC-MAP3.
| Condition | Intervention |
|---|---|
|
Breast Cancer Osteoporosis |
Drug: exemestane Other: biologic sample preservation procedure Other: physiologic testing Procedure: dual x-ray absorptometry |
| Study Type: | Observational |
| Official Title: | The Influence of Five Years of Exemestane on Bone Mineral Density in Postmenopausal Women at Increased Risk of Developing Breast Cancer |
| Estimated Enrollment: | 480 |
| Study Start Date: | January 2008 |
| Estimated Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients undergo bone mineral density (BMD) measurement by dual x-ray absorptometry (DEXA). Blood specimens are collected at baseline and at 1 year, and 5 years and stored in a central laboratory for future assays of the bone biomarkers.
If the subject withdraws from the core MAP.3 study before 5 years, a bone density measurement and serum for bone biomarkers is obtained unless performed within the past 3 months. Patients may continue to be followed on the MAP.3 core study for fractures (and other MAP.3 study endpoints) for a minimum of 5 years after randomization.
Eligibility| Ages Eligible for Study: | 35 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Postmenopausal, defined as one of the following:
PRIOR CONCURRENT THERAPY:
No concurrent medication that may have an effect on study endpoints for this study, including any of the following:
Contacts and Locations| United States, California | |
| Los Angeles Biomedical Research Institute | Recruiting |
| Torrance, California, United States, 90502 | |
| Contact: Rowan Chlebowski 310-222-2217 | |
| United States, District of Columbia | |
| George Washington University Medical Center | Recruiting |
| Washington, District of Columbia, United States, 20037 | |
| Contact: Clinical Trials Office - George Washington University Medical 202-741-2981 | |
| United States, Maine | |
| Maine Center for Cancer Medicine and Blood Disorders - Scarborough | Recruiting |
| Scarborough, Maine, United States, 04074-9308 | |
| Contact: Tracey F. Weisberg 207-885-7600 | |
| United States, Maryland | |
| Suburban Hospital Cancer Program | Recruiting |
| Bethesda, Maryland, United States, 20817 | |
| Contact: Carolyn Hendricks 301-897-1503 | |
| United States, Massachusetts | |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Judy E. Garber 617-632-3800 | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Clinical Trials Office - Massachusetts General Hospital 877-726-5130 | |
| United States, Michigan | |
| Hutzel Hospital | Recruiting |
| Detroit, Michigan, United States, 48201 | |
| Contact: Susan Hendrix 313-745-0499 | |
| United States, New Jersey | |
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | Recruiting |
| New Brunswick, New Jersey, United States, 08903 | |
| Contact: Clinical Trials Office - Cancer Institute of New Jersey 732-235-8675 | |
| United States, Oklahoma | |
| Oklahoma University Cancer Institute | Recruiting |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Contact: William C. Dooley 405-271-7867 | |
| United States, Rhode Island | |
| Memorial Hospital of Rhode Island | Recruiting |
| Pawtucket, Rhode Island, United States, 02860 | |
| Contact: Michele Cyr 401-444-8537 | |
| United States, Vermont | |
| Fletcher Allen Health Care - University Health Center Campus | Recruiting |
| Burlington, Vermont, United States, 05401 | |
| Contact: Clinical Trials Office - Fletcher Allen Health Care 802-656-8990 | |
| United States, Washington | |
| Fred Hutchinson Cancer Research Center | Recruiting |
| Seattle, Washington, United States, 98109-1024 | |
| Contact: Anne McTiernan 206-667-6196 | |
| United States, Wisconsin | |
| University of Wisconsin Center for Women's Health Research | Recruiting |
| Madison, Wisconsin, United States, 53715 | |
| Contact: Gloria E. Sarto 608-267-5572 | |
| Canada, British Columbia | |
| British Columbia Cancer Agency - Centre for the Southern Interior | Recruiting |
| Kelowna, British Columbia, Canada, V1Y 5L3 | |
| Contact: Susan Ellard 250-712-3922 | |
| British Columbia Cancer Agency - Vancouver Cancer Centre | Recruiting |
| Vancouver, British Columbia, Canada, V5Z 4E6 | |
| Contact: Karen Gelmon 604-877-6000 | |
| Canada, Ontario | |
| London Regional Cancer Program at London Health Sciences Centre | Recruiting |
| London, Ontario, Canada, N6A 4L6 | |
| Contact: Eric W. Winquist 519-685-8640 | |
| Northeastern Ontario Regional Cancer Centre | Recruiting |
| Sudbury, Ontario, Canada, P3E 5J1 | |
| Contact: Amanda Hey 705-522-6237 | |
| Princess Margaret Hospital | Recruiting |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Contact: Angela M. Cheung 416-340-4301 | |
| Study Chair: | Paul E. Goss, MD, PhD | Massachusetts General Hospital |
More Information
| Study ID Numbers: | CDR0000586285, CAN-NCIC-MAP3B, PFIZER-NCIC-MAP3B |
| Study First Received: | May 30, 2008 |
| Last Updated: | June 3, 2009 |
| ClinicalTrials.gov Identifier: | NCT00688246 History of Changes |
| Health Authority: | Unspecified |
|
osteoporosis breast cancer |
|
Molecular Mechanisms of Pharmacological Action Skin Diseases Antineoplastic Agents Breast Neoplasms Osteoporosis Bone Diseases, Metabolic Enzyme Inhibitors Bone Diseases Pharmacologic Actions |
Neoplasms Neoplasms by Site Musculoskeletal Diseases Therapeutic Uses Osteoporosis, Postmenopausal Exemestane Aromatase Inhibitors Breast Diseases |