![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) North Central Cancer Treatment Group Eastern Cooperative Oncology Group National Surgical Adjuvant Breast and Bowel Project (NSABP) Cancer and Leukemia Group B NCIC Clinical Trials Group |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00127205 |
RATIONALE: Zoledronate, clodronate, or ibandronate may delay or prevent bone metastases in patients with nonmetastatic breast cancer. It is not yet known whether zoledronate is more effective than clodronate or ibandronate in treating breast cancer.
PURPOSE: This randomized phase III trial is studying zoledronate to see how well it works compared to clodronate or ibandronate in treating women who have undergone surgery for stage I, stage II, or stage III breast cancer.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: clodronate disodium Drug: ibandronate sodium Drug: zoledronic acid |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer |
Estimated Enrollment: | 4500 |
Study Start Date: | July 2005 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Arm I: Experimental
Patients receive zoledronate IV over 15 minutes once a month for 6 months and then once every 3 months for 2.5 years.
|
Drug: zoledronic acid
Given IV
|
Arm II: Active Comparator
Patients receive oral clodronate once daily for 3 years.
|
Drug: clodronate disodium
Given orally
|
Arm III: Experimental
Patients receive oral ibandronate once daily for 3 years.
|
Drug: ibandronate sodium
Given orally
|
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 3 treatment arms.
After completion of study treatment, patients are followed every 6 months until disease recurrence and then annually for up to 10 years.
PROJECTED ACCRUAL: A total of 4,500 will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed primary adenocarcinoma of the breast
Must have undergone lumpectomy or total mastectomy for primary disease within the past 12 weeks, or have completed chemotherapy within the past 8 weeks
Currently receiving or planning to receive standard adjuvant systemic therapy comprising chemotherapy, hormonal therapy, or combined chemotherapy/hormonal therapy for breast cancer
Patients with skeletal pain are eligible provided bone scan and/or roentgenological exam are negative for metastatic disease
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
No history of esophageal stricture or motility disorders
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent enrollment in clinical trials with bone density as an endpoint
United States, Indiana | |
Clarian Arnett Cancer Care | Recruiting |
Lafayette, Indiana, United States, 47904 | |
Contact: Thomas I. Jones, MD 765-448-7500 | |
United States, Kansas | |
Associates in Womens Health, PA - North Review | Recruiting |
Wichita, Kansas, United States, 67208 | |
Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
Cancer Center of Kansas - Fort Scott | Recruiting |
Fort Scott, Kansas, United States, 66701 | |
Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
Cancer Center of Kansas, PA - Kingman | Recruiting |
Kingman, Kansas, United States, 67068 | |
Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
Cancer Center of Kansas, PA - Wichita | Recruiting |
Wichita, Kansas, United States, 67214 | |
Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
Cancer Center of Kansas, PA - Parsons | Recruiting |
Parsons, Kansas, United States, 67357 | |
Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
Cancer Center of Kansas, PA - Dodge City | Recruiting |
Dodge City, Kansas, United States, 67801 | |
Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
Cancer Center of Kansas, PA - El Dorado | Recruiting |
El Dorado, Kansas, United States, 67042 | |
Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
Cancer Center of Kansas, PA - Medical Arts Tower | Recruiting |
Wichita, Kansas, United States, 67208 | |
Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
Cancer Center of Kansas, PA - Newton | Recruiting |
Newton, Kansas, United States, 67114 | |
Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
Cancer Center of Kansas, PA - Chanute | Recruiting |
Chanute, Kansas, United States, 66720 | |
Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
Cancer Center of Kansas, PA - Pratt | Recruiting |
Pratt, Kansas, United States, 67124 | |
Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
Cancer Center of Kansas, PA - Salina | Recruiting |
Salina, Kansas, United States, 67042 | |
Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
Cancer Center of Kansas, PA - Wellington | Recruiting |
Wellington, Kansas, United States, 67152 | |
Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
Cancer Center of Kansas, PA - Winfield | Recruiting |
Winfield, Kansas, United States, 67156 | |
Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
Cancer Center of Kansas-Independence | Recruiting |
Independence, Kansas, United States, 67301 | |
Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
CCOP - Wichita | Recruiting |
Wichita, Kansas, United States, 67214 | |
Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
Lawrence Memorial Hospital | Recruiting |
Lawrence, Kansas, United States, 66044 | |
Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
Southwest Medical Center | Recruiting |
Liberal, Kansas, United States, 67901 | |
Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
Via Christi Cancer Center at Via Christi Regional Medical Center | Recruiting |
Wichita, Kansas, United States, 67214 | |
Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
United States, New Jersey | |
Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare | Recruiting |
Vineland, New Jersey, United States, 08360 | |
Contact: Clinical Trials Office - Franklin & Edith Scarpa Regional Canc 856-641-7933 | |
United States, North Carolina | |
Mission Hospitals - Memorial Campus | Recruiting |
Asheville, North Carolina, United States, 28801 | |
Contact: Clinical Trials Office - Mission Hospitals - Memorial Campus 828-213-4150 |
Investigator: | Julie R. Gralow, MD | Seattle Cancer Care Alliance |
Investigator: | Robert B. Livingston, MD | University of Arizona |
Investigator: | James N. Ingle, MD | Mayo Clinic |
Investigator: | Carla I. Falkson, MD | University of Alabama at Birmingham |
Investigator: | Alexander H. G. Paterson, MD, FRCP, FACP, MBChB | Tom Baker Cancer Centre - Calgary |
Investigator: | Elizabeth C. Dees, MD | UNC Lineberger Comprehensive Cancer Center |
Investigator: | Mark J. Clemons, MD | Edmond Odette Cancer Centre at Sunnybrook |
Responsible Party: | Southwest Oncology Group - Group Chair's Office ( Laurence H. Baker ) |
Study ID Numbers: | CDR0000437061, SWOG-S0307, NCCTG-SWOG-S0307, ECOG-SWOG-S0307, NSABP-SWOG-S0307, CALGB-SWOG-S0307, CAN-NCIC-SWOG-S0307 |
Study First Received: | August 3, 2005 |
Last Updated: | September 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00127205 History of Changes |
Health Authority: | Unspecified |
stage I breast cancer stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer |
Clodronic Acid Diphosphonates Zoledronic acid Ibandronic acid Skin Diseases |
Adjuvants, Immunologic Breast Neoplasms Bone Density Conservation Agents Breast Diseases |
Clodronic Acid Neoplasms Zoledronic acid Neoplasms by Site Ibandronic acid Skin Diseases |
Physiological Effects of Drugs Breast Neoplasms Bone Density Conservation Agents Pharmacologic Actions Breast Diseases |