Exemestane, Letrozole, or Anastrozole in Treating Postmenopausal Women Who Are Undergoing Surgery for Stage II or Stage III Breast Cancer
A total of 567 patients (375 for cohort A and 192 for cohort B) will be accrued for this study.
This is a multicenter study comprising cohort A (phase III study) and cohort B (phase II study). Once cohort A accrual is met (375 patients), subsequent patients are enrolled to cohort B. Patients in both cohorts are stratified according to T stage (T2 vs T3 vs T4), and randomized to 1 of 3 aromatase inhibition (AI) treatment arms.
Patients in cohort B undergo breast biopsy after 2-4 weeks of AI treatment for analysis of Ki-67 levels. Patients with Ki-67 level ≤ 10% continue AI treatment. Patients with Ki-67 level > 10% (high) are given the option to switch to neoadjuvant
chemotherapy or undergo immediate breast surgery.
After completion of AI therapy, all patients undergo partial or radical mastectomy or lumpectomy with or without lymph node dissection.
After surgery, patients are followed up periodically for 10 years.
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| U.S.A. |
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| Alabama |
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Mobile |
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| | University of South Alabama Mitchell Cancer Institute |
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| | Donna Dyess | |
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| California |
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Burbank |
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| | Providence Saint Joseph Medical Center - Burbank |
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| | Clinical Trials Office - Providence Saint Joseph Medical Center - Burbank | |
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Los Angeles |
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| | USC/Norris Comprehensive Cancer Center and Hospital |
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| | Clinical Trials Office - USC/Norris Comprehensive Cancer Center and Hospital | |
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Palm Springs |
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| | Desert Regional Medical Center Comprehensive Cancer Center |
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| | Clinical Trials Office - Desert Regional Medical Center Comprehensive Cancer Center | |
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| Colorado |
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Colorado Springs |
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| | Memorial Hospital Cancer Center - Colorado Springs |
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| | Clinical Trials Office - Memorial Hospital | |
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| Delaware |
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Lewes |
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| | Tunnell Cancer Center at Beebe Medical Center |
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| | Clinical Trials Office - Tunnell Cancer Center | |
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Newark |
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| | CCOP - Christiana Care Health Services |
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| | Clinical Trial Office - CCOP - Christiana Care Health Services | |
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| Florida |
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Fort Lauderdale |
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| | Michael and Dianne Bienes Comprehensive Cancer Center
at Holy Cross Hospital |
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| | Clinical Trials Office - Michael and Dianne Bienes Comprehensive Cancer Center | |
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Jupiter |
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| | Ella Milbank Foshay Cancer Center at Jupiter Medical Center |
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| | Clinical Trials Office - Ella Milbank Foshay Cancer Center | |
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Miami Beach |
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| | CCOP - Mount Sinai Medical Center |
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| | Juan Paramo | |
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| Georgia |
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Columbus |
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| | John B. Amos Cancer Center |
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| | Clinical Trials Office - John B. Amos Cancer Center | |
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Decatur |
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| | Charles B. Eberhart Cancer Center at DeKalb Medical Center |
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| | John Kennedy, MD | |
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Gainesville |
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| | Northeast Georgia Medical Center |
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| | Pierce Dixon, MD | |
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Savannah |
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| | Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center |
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| | Clinical Trials Office - Curtis and Elizabeth Anderson Cancer Institute | |
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| | Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler |
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| | Mark Taylor, MD | |
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Valdosta |
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| | Pearlman Comprehensive Cancer Center at South Georgia Medical Center |
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| | Jeffrey Hoy, MD | |
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| Illinois |
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Evanston |
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| | Evanston Hospital |
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| | Clinical Trials Office - Evanston Hospital | |
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| Indiana |
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Munster |
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| | Community Hospital |
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| | Erwin Robin, MD | |
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| Iowa |
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Ames |
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| | McFarland Clinic, PC |
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| | Clinical Trials Office - McFarland Clinic, PC | |
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| Kentucky |
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Edgewood |
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| | Esther Marie Hatton Cancer Care Center at St. Elizabeth Medical Center |
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| | Joseph Guenther, MD | |
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Lexington |
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| | Central Baptist Hospital |
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| | Clinical Trials Office - Central Baptist Hospital | |
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Louisville |
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| | Drs. Carrol, Sheth, Raghavan |
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| | J. Philip Kuebler, MD, PhD | |
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| Maine |
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York |
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| | York Hospital's Oncology Treatment Center |
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| | Jonathan Eneman | |
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| Maryland |
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Baltimore |
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| | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
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| | Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Center at John Hopkins | |
| | Email:
jhcccro@jhmi.edu |
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Elkton MD |
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| | Union Hospital Cancer Program at Union Hospital |
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| | Diana Dickson-Witmer | |
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Towson |
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| | Cancer Institute at St. Joseph Medical Center |
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| | Michael Schultz | |
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| Massachusetts |
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Boston |
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| | Boston University Cancer Research Center |
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| | Clinical Trials Office - Boston University Cancer Research Center | |
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| Michigan |
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Adrian |
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| | Hickman Cancer Center at Bixby Medical Center |
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| | Clinical Trials Office - Hickman Cancer Center at Bixby Medical Center | |
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Detroit |
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| | Barbara Ann Karmanos Cancer Institute |
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| | Clinical Trials Office - Barbara Ann Karmanos Cancer Institute | |
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| | Josephine Ford Cancer Center at Henry Ford Hospital |
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| | S. David Nathanson, MD | |
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Escanaba |
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| | Green Bay Oncology, Limited - Escanaba |
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| | Thomas Saphner, MD, FACP | |
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Iron Mountain |
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| | Dickinson County Healthcare System |
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| | Thomas Saphner, MD, FACP | |
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Kalamazoo |
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| | Borgess Medical Center |
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| | Raymond Lord, MD | |
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| | Bronson Methodist Hospital |
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| | Raymond Lord, MD | |
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| | West Michigan Cancer Center |
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| | Clinical Trials Office - West Michigan Cancer Center | |
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Lambertville |
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| | Haematology-Oncology Associates of Ohio and Michigan, PC |
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| | Paul Schaefer, MD | |
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Monroe |
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| | Community Cancer Center of Monroe |
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| | Paul Schaefer, MD | |
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| | Mercy Memorial Hospital - Monroe |
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| | Paul Schaefer, MD | |
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| Minnesota |
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Rochester |
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| | Mayo Clinic Cancer Center |
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| | Clinical Trials Office - All Mayo Clinic Locations | |
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| Nebraska |
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Omaha |
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| | Methodist Estabrook Cancer Center |
|
| | James Reilly, MD | |
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| Nevada |
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Las Vegas |
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| | CCOP - Nevada Cancer Research Foundation |
|
| | John Ellerton, MD, CM | |
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| | University Medical Center of Southern Nevada |
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| | John Ellerton, MD, CM | |
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| New Hampshire |
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Exeter |
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| | Center for Cancer Care at Exeter Hospital |
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| | Danny Sims | |
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| New Jersey |
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New Brunswick |
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| | Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School |
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| | Clinical Trials Office - Cancer Institute of New Jersey | |
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Voorhees |
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| | Cancer Institute of New Jersey at Cooper - Voorhees |
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| | Clinical Trials Office - Cancer Institute of New Jersey at Cooper University Hospital - Voorhees | |
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| New Mexico |
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Albuquerque |
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| | Hematology Oncology Associates, PC |
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| | Anne Wallace, MD | |
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| | New Mexico Cancer Center |
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| | Anne Wallace, MD | |
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| | Presbyterian Cancer Treatment Center at Presbyterian Kaseman Hospital |
|
| | Anne Wallace, MD | |
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| | University of New Mexico Cancer Center |
|
| | Clinical Trials Office - University of New Mexico Cancer Center | |
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Santa Fe |
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| | New Mexico Cancer Care Associates |
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| | Clinical Trials Office - New Mexico Cancer Care Associates | |
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| North Carolina |
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Durham |
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| | Duke Comprehensive Cancer Center |
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| | Clinical Trials Office - Duke Comprehensive Cancer Center | |
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Goldsboro |
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| | Southeastern Medical Oncology Center - Goldsboro |
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| | James Atkins, MD | |
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| | Wayne Memorial Hospital, Incorporated |
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| | James Atkins, MD | |
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Kinston |
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| | Kinston Medical Specialists |
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| | Peter Watson, MD | |
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Winston-Salem |
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| | Wake Forest University Comprehensive Cancer Center |
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| | Clinical Trials Office - Wake Forest University Comprehensive Cancer Center | |
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| North Dakota |
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Grand Forks |
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| | Altru Cancer Center at Altru Hospital |
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| | Clinical Trails Office - Altru Cancer Center at Altru Hospital | |
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| Ohio |
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Akron |
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| | McDowell Cancer Center at Akron General Medical Center |
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| | Daniel Guyton, MD | |
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Bellefontaine |
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| | Mary Rutan Hospital |
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| | J. Philip Kuebler, MD, PhD | |
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Bowling Green |
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| | Wood County Oncology Center |
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| | Paul Schaefer, MD | |
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Chillicothe |
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| | Adena Regional Medical Center |
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| | Clinical Trials Office - Adena Regional Medical Center | |
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Cincinnati |
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| | Bethesda North Hospital |
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| | Joseph Guenther, MD | |
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| | Good Samaritan Hospital Cancer Treatment Center |
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| | Joseph Guenther, MD | |
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Clyde |
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| | North Coast Cancer Care - Clyde |
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| | Paul Schaefer, MD | |
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Columbus |
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| | CCOP - Columbus |
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| | J. Philip Kuebler, MD, PhD | |
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| | Doctors Hospital at Ohio Health |
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| | Clinical Trials Office - Doctors Hospital at Ohio Health | |
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| | Grant Medical Center Cancer Care |
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| | Clinical Trials Office - Grant Medical Center Cancer Care | |
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| | Mount Carmel Health - West Hospital |
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| | J. Philip Kuebler, MD, PhD | |
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| | Riverside Methodist Hospital Cancer Care |
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| | Clinical Trials Office - Riverside Methodist Hospital Cancer Care | |
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Delaware |
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| | Grady Memorial Hospital |
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| | J. Philip Kuebler, MD, PhD | |
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Elyria |
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| | Hematology Oncology Center |
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| | Paul Schaefer, MD | |
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Lancaster |
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| | Fairfield Medical Center |
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| | J. Philip Kuebler, MD, PhD | |
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Lima |
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| | Lima Memorial Hospital |
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| | Paul Schaefer, MD | |
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| | St. Rita's Medical Center |
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| | Clinical Trials Office - St. Rita's Medical Center | |
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Marietta |
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| | Strecker Cancer Center at Marietta Memorial Hospital |
|
| | J. Philip Kuebler, MD, PhD | |
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Maumee |
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| | Northwest Ohio Oncology Center |
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| | Paul Schaefer, MD | |
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| | Paul Schaefer, MD | |
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| | St. Luke's Hospital |
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| | Paul Schaefer, MD | |
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Newark |
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| | Licking Memorial Cancer Care Program at Licking Memorial Hospital |
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| | J. Philip Kuebler, MD, PhD | |
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Oregon |
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| | St. Charles Mercy Hospital |
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| | Paul Schaefer, MD | |
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| | Toledo Clinic - Oregon |
|
| | Paul Schaefer, MD | |
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Sandusky |
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| | North Coast Cancer Care, Incorporated |
|
| | Paul Schaefer, MD | |
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Springfield |
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| | Community Hospital of Springfield and Clark County |
|
| | J. Philip Kuebler, MD, PhD | |
|
| | Mercy Medical Center |
|
| | J. Philip Kuebler, MD, PhD | |
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Sylvania |
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| | Flower Hospital Cancer Center |
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| | Clinical Trials Office - Flower Hospital Cancer Center | |
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Tiffin |
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| | Mercy Hospital of Tiffin |
|
| | Paul Schaefer, MD | |
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Toledo |
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|
| | CCOP - Toledo Community Hospital |
|
| | Paul Schaefer, MD | |
|
| | Medical University of Ohio Cancer Center |
|
| | Clinical Trials Office - Medical University of Ohio Cancer Center | |
|
| | St. Anne Mercy Hospital |
|
| | Paul Schaefer, MD | |
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| | St. Vincent Mercy Medical Center |
|
| | Paul Schaefer, MD | |
|
| | Toledo Clinic, Incorporated - Main Clinic |
|
| | Paul Schaefer, MD | |
|
| | Toledo Hospital |
|
| | Clinical Trials Office - Toledo Hospital | |
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Wauseon |
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| | Fulton County Health Center |
|
| | Clinical Trials Office - Fulton County Health Center | |
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| |
Westerville |
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| | Mount Carmel St. Ann's Cancer Center |
|
| | J. Philip Kuebler, MD, PhD | |
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Zanesville |
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|
| | Genesis - Good Samaritan Hospital |
|
| | Clinical Trials Office - Genesis - Good Samaritan Hospital | |
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| Pennsylvania |
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Allentown |
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| | Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest |
|
| | Paul Mosca | |
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| | Sacred Heart Hospital |
|
| | Mark Gittleman, MD | |
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Bethlehem |
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| | St. Luke's Cancer Network at St. Luke's Hospital |
|
| | Darius Desai, MD | |
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Phoenixville |
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| | Cancer Center at Phoenixville Hospital |
|
| | Carl Sharer, DO | |
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| |
York |
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| | York Cancer Center at Apple Hill Medical Center |
|
| | Ronald Hempling, MD | |
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| South Carolina |
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| |
Charleston |
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|
| | Hollings Cancer Center at Medical University of South Carolina |
|
| | Clinical Trials Office - Hollings Cancer Center at Medical University of South Carolina | |
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| |
Hilton Head Island |
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| | Hilton Head Regional Medical Center |
|
| | Megan Baker Ruppel | |
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| |
Spartanburg |
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|
| | CCOP - Upstate Carolina |
|
| | Clinical Trials Office - CCOP - Upstate Carolina | |
|
| | Gibbs Regional Cancer Center at Spartanburg Regional Medical Center |
|
| | Clinical Trials Office - Gibbs Regional Cancer Center | |
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| Tennessee |
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| |
Nashville |
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|
| | Baptist Hospital |
|
| | Pat Whitworth, MD | |
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| Texas |
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| |
Dallas |
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|
| | Dallas Surgical Group |
|
| | Peter Beitsch, MD, FACS | |
|
| | Parkland Memorial Hospital |
|
| | Ann Leitch, MD | |
|
| | Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas |
|
| | Clinical Trials Office - Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | | Ph: | 866-460-4673; 214-648-7097 | | |
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|
| | UT Southwestern University Hospital - Zale Lipshy |
|
| | Ann Leitch, MD | |
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| |
Houston |
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| | M. D. Anderson Cancer Center at University of Texas |
|
| | Clinical Trials Office - M. D. Anderson Cancer Center at the University of Texas | |
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| |
Laredo |
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|
| | Doctor's Hospital of Laredo |
|
| | Gary Unzeitig, MD | |
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| |
Lubbock |
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|
| | Joe Arrington Cancer Research and Treatment Center |
|
| | Clinical Trials Office - Joe Arrington Cancer Research and Treatment Center | |
| | Email:
jaccresearch@covhs.org |
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| Virginia |
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| |
Fredericksburg |
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|
| | Fredericksburg Oncology, Incorporated |
|
| | Paul Schaefer, MD | |
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| |
Richmond |
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|
| | Virginia Commonwealth University Massey Cancer Center |
|
| | Clinical Trials Office -Virginia Commonwealth University Massey Cancer Center | |
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| Washington |
 |
| |
Seattle |
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|
| | Swedish Cancer Institute at Swedish Medical Center - First Hill Campus |
|
| | J. David Beatty, MD | |
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| Wisconsin |
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| |
Green Bay |
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|
| | Green Bay Oncology, Limited at St. Mary's Hospital |
|
| | Thomas Saphner, MD, FACP | |
|
| | Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center |
|
| | Thomas Saphner, MD, FACP | |
|
| | St. Mary's Hospital Medical Center - Green Bay |
|
| | Thomas Saphner, MD, FACP | |
|
| | St. Vincent Hospital Regional Cancer Center |
|
| | Clinical Trials Office - St. Vincent Hospital Regional Cancer Center | |
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| |
Manitowoc |
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| | Holy Family Memorial Medical Center Cancer Care Center |
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| | Clinical Trials Office - Holy Family Memorial Medical Center Cancer Care Center | |
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| |
Marinette |
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| | Bay Area Cancer Care Center at Bay Area Medical Center |
|
| | Thomas Saphner, MD, FACP | |
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| |
Milwaukee |
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| | Froedtert Hospital and Medical College of Wisconsin |
|
| | Clinical Trials Office - Froedtert Hospital | |
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| |
Oconto Falls |
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| | Green Bay Oncology, Limited - Oconto Falls |
|
| | Thomas Saphner, MD, FACP | |
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Sturgeon Bay |
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| | Green Bay Oncology, Limited - Sturgeon Bay |
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| | Thomas Saphner, MD, FACP | |
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| Ireland |
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| |
Dublin |
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| | Beaumont Hospital |
|
| | Arnold Hill, MD, MCh, FRCSI | |
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