New combo aims to stop early breast cancer in its tracks

NCT ID NCT05827081

Recruiting now Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jul 17, 2026 · Updated 8 times

Summary

This phase 3 trial is testing whether adding the targeted drug ribociclib to standard hormone therapy can help prevent invasive breast cancer from returning in people with HR+ HER2- early breast cancer. About 1,400 participants will receive the combination for up to 3 years. The main goal is to see how many remain cancer-free after 3 years.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Ribociclib (a targeted cancer drug) plus hormone therapy (letrozole, anastrozole, goserelin, or leuprolide)
What this could lead to: If successful, this combination could help prevent early breast cancer from coming back in patients with HR+ HER2- disease.
What could go wrong: This is an early-phase, single-arm study with no placebo group, so results may be less definitive. Side effects from ribociclib can include infections, fatigue, and liver issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm hormone receptor-positive breast cancer male breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

EARLY BREAST CANCER

Contacts and locations

Locations

AdventHealth Altamonte Springs
RECRUITING

Altamonte Springs, Florida, 32701, United States
AdventHealth Medical Group Hematology and Oncology
RECRUITING

Denver, Colorado, 80210, United States
Affiliated Oncologists IL
RECRUITING

Chicago, Illinois, 60415, United States
Alaska Oncology and Hematology LLC
RECRUITING

Anchorage, Alaska, 99508, United States
Allegheny Health Network
RECRUITING

Pittsburgh, Pennsylvania, 15212, United States
Allina Hlth Cancer Inst Minneapolis
RECRUITING

Minneapolis, Minnesota, 55407, United States
Beverly Hills Cancer Center
RECRUITING

Beverly Hills, California, 90211, United States
Bon Secours St Francis Cancer Center
RECRUITING

Greenville, South Carolina, 29607, United States
Bon Secours Virginia Health System
RECRUITING

Midlothian, Virginia, 23114, United States
Boston Medical Center
RECRUITING

Boston, Massachusetts, 02118, United States
CARTI Cancer Center
RECRUITING

Little Rock, Arkansas, 72205, United States
Cancer Care Specialists
RECRUITING

Reno, Nevada, 89511, United States
Cancer Center of Kansas
RECRUITING

Wichita, Kansas, 67214-3728, United States
Central Alabama Research
RECRUITING

Birmingham, Alabama, 35209, United States
City of Hope National Medical
RECRUITING

Duarte, California, 91010, United States
Cone Health Cancer Center
RECRUITING

Greensboro, North Carolina, 27403, United States
Consultants In Med Onco And Hema
RECRUITING

Drexel Hill, Pennsylvania, 19026, United States
Dana Farber Brigham Women Cancer
RECRUITING

Milford, Massachusetts, 01757, United States
Dana Farber Cancer Institute
RECRUITING

Boston, Massachusetts, 02215, United States
Duke Cancer Network
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Durham, North Carolina, 27710, United States
El Camino Hospital
RECRUITING

Mountain View, California, 94040, United States
El Paso Texas Oncology
RECRUITING

El Paso, Texas, 79902, United States
Georgetown University Lombardi Cancer Center
RECRUITING

Washington D.C., District of Columbia, 20007-2197, United States
Good Samaritan Regional Medical Center
RECRUITING

Corvallis, Oregon, 97330, United States
HCA Midwest Division
RECRUITING

Kansas City, Missouri, 64132, United States
Hawaii Cancer Care
RECRUITING

Honolulu, Hawaii, 96813, United States
Hialeah Hospital
RECRUITING

Hialeah, Florida, 33013, United States
Holy Cross Health
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Fort Lauderdale, Florida, 33308, United States
Hope And Healing Care
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Hinsdale, Illinois, 60521, United States
Intermountain Healthcare
RECRUITING

Billings, Montana, 59102, United States
Investigative Clinical R of Indiana
RECRUITING

Indianapolis, Indiana, 46260, United States
Jackson Oncology Associates
RECRUITING

Jackson, Mississippi, 39202, United States
Jupiter Medical Center
RECRUITING

Jupiter, Florida, 33458, United States
Kadlec Clinic Hematology and Onco
RECRUITING

Kennewick, Washington, 99336, United States
Kelsey Seybold Clinic
RECRUITING

Houston, Texas, 77025, United States
Lexington Medical Center
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West Columbia, South Carolina, 29169, United States
Los Angeles Cancer Network Good Samaritan
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Los Angeles, California, 90017, United States
MD Anderson Cancer Center At Cooper
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Camden, New Jersey, 08103, United States
Maryland Oncology Hematology P A
RECRUITING

Silver Spring, Maryland, 20904, United States
Medical College of Wisconsin
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Milwaukee, Wisconsin, 53226, United States
Medstar Washington Hospital Center
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Washington D.C., District of Columbia, 20010, United States
Memorial Cancer Institute
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Hollywood, Florida, 33021, United States
Mercy Medical Center
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Baltimore, Maryland, 21202, United States
Midwestern Reg MC COH Chicago
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Zion, Illinois, 60099, United States
Minnesota Oncology Hematology P A
RECRUITING

Minneapolis, Minnesota, 55404, United States
Mount Sinai School of Medicine
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New York, New York, 10029, United States
Nebraska Cancer Specialists
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Omaha, Nebraska, 68154, United States
Northwest Cancer Specialists
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Portland, Oregon, 97210, United States
Northwest Medical Specialties
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Tacoma, Washington, 98405, United States
Novartis Investigative Site
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Caba, Buenos Aires, C1426ANZ, Argentina
Novartis Investigative Site
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La Plata, Buenos Aires, B1902CMV, Argentina
Novartis Investigative Site
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Córdoba, X5004BAL, Argentina
Novartis Investigative Site
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Gateshead, New South Wales, 2290, Australia
Novartis Investigative Site
RECRUITING

Tiwi, Northern Territory, 810, Australia
Novartis Investigative Site
RECRUITING

Clayton, Victoria, 3168, Australia
Novartis Investigative Site
RECRUITING

East Melbourne, Victoria, 3002, Australia
Novartis Investigative Site
RECRUITING

Salvador, Estado de Bahia, 40170-110, Brazil
Novartis Investigative Site
RECRUITING

Salvador, Estado de Bahia, 41825-010, Brazil
Novartis Investigative Site
RECRUITING

Belo Horizonte, Minas Gerais, 30220-140, Brazil
Novartis Investigative Site
RECRUITING

Porto Alegre, Rio Grande do Sul, 90470-340, Brazil
Novartis Investigative Site
RECRUITING

Porto Alegre, Rio Grande do Sul, 90560-032, Brazil
Novartis Investigative Site
RECRUITING

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Novartis Investigative Site
RECRUITING

São Paulo, São Paulo, 05652-000, Brazil
Novartis Investigative Site
RECRUITING

Rio de Janeiro, 22281-100, Brazil
Novartis Investigative Site
RECRUITING

Rio de Janeiro, 22775-001, Brazil
Novartis Investigative Site
RECRUITING

São Paulo, 01323-000, Brazil
Novartis Investigative Site
RECRUITING

São Paulo, 04501 000, Brazil
Novartis Investigative Site
RECRUITING

Victoria, British Columbia, V8R 6V5, Canada
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RECRUITING

Halifax, Nova Scotia, B3H 2Y9, Canada
Novartis Investigative Site
RECRUITING

Oakville, Ontario, L6M1M1, Canada
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RECRUITING

Ottawa, Ontario, K1H 8L6, Canada
Novartis Investigative Site
RECRUITING

Toronto, Ontario, M4N 3M5, Canada
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Montreal, Quebec, H2X 0A9, Canada
Novartis Investigative Site
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Montreal, Quebec, H3T 1E2, Canada
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Montreal, Quebec, H4A 3J1, Canada
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Québec, Quebec, G1S 4L8, Canada
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RECRUITING

Saskatoon, Saskatchewan, S7N 4H4, Canada
Novartis Investigative Site
RECRUITING

Beijing, Beijing Municipality, 100044, China
Novartis Investigative Site
RECRUITING

Guangzhou, Guangdong, 510080, China
Novartis Investigative Site
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Harbin, Heilongjiang, 150081, China
Novartis Investigative Site
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Zhengzhou, Henan, 450003, China
Novartis Investigative Site
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Zhengzhou, Henan, 450008, China
Novartis Investigative Site
RECRUITING

Nanjing, Jiangsu, 210029, China
Novartis Investigative Site
RECRUITING

Nanchang, Jiangxi, 330009, China
Novartis Investigative Site
RECRUITING

Changchun, Jilin, 130021, China
Novartis Investigative Site
ACTIVE_NOT_RECRUITING

Jinan, Shandong, 250021, China
Novartis Investigative Site
RECRUITING

Jinan, Shandong, 250117, China
Novartis Investigative Site
RECRUITING

Jining, Shandong, 272000, China
Novartis Investigative Site
RECRUITING

Chengdu, Sichuan, 610041, China
Novartis Investigative Site
RECRUITING

Chengdu, Sichuan, 610072, China
Novartis Investigative Site
RECRUITING

Ürümqi, Xinjiang, 830000, China
Novartis Investigative Site
RECRUITING

Hangzhou, Zhejiang, 310006, China
Novartis Investigative Site
RECRUITING

Hangzhou, Zhejiang, 310022, China
Novartis Investigative Site
RECRUITING

Wenzhou, Zhejiang, 325000, China
Novartis Investigative Site
RECRUITING

Beijing, 100039, China
Novartis Investigative Site
RECRUITING

Beijing, 100730, China
Novartis Investigative Site
RECRUITING

Guangzhou, 510060, China
Novartis Investigative Site
RECRUITING

Qingdao, 266000, China
Novartis Investigative Site
RECRUITING

Shanghai, 200032, China
Novartis Investigative Site
RECRUITING

Shijiazhuang, 050035, China
Novartis Investigative Site
RECRUITING

Tianjin, 300480, China
Novartis Investigative Site
RECRUITING

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
Novartis Investigative Site
RECRUITING

Munich, Bavaria, 81377, Germany
Novartis Investigative Site
RECRUITING

Regensburg, Bavaria, 93053, Germany
Novartis Investigative Site
RECRUITING

Weiden in Der Oberpfalz, Bavaria, 92637, Germany
Novartis Investigative Site
RECRUITING

Langen, Hesse, 63225, Germany
Novartis Investigative Site
WITHDRAWN

Hildesheim, Lower Saxony, 31134, Germany
Novartis Investigative Site
RECRUITING

Bergisch Gladbach, North Rhine-Westphalia, 51465, Germany
Novartis Investigative Site
WITHDRAWN

Bielefeld, North Rhine-Westphalia, 33604, Germany
Novartis Investigative Site
WITHDRAWN

Düsseldorf, North Rhine-Westphalia, 40225, Germany
Novartis Investigative Site
RECRUITING

Essen, North Rhine-Westphalia, 45136, Germany
Novartis Investigative Site
RECRUITING

Mönchengladbach, North Rhine-Westphalia, 41061, Germany
Novartis Investigative Site
RECRUITING

Velbert, North Rhine-Westphalia, 42551, Germany
Novartis Investigative Site
RECRUITING

Dresden, Saxony, 01307, Germany
Novartis Investigative Site
WITHDRAWN

Lübeck, Schleswig-Holstein, 23563, Germany
Novartis Investigative Site
RECRUITING

Augsburg, 86150, Germany
Novartis Investigative Site
RECRUITING

Augsburg, 86179, Germany
Novartis Investigative Site
RECRUITING

Berlin, 10967, Germany
Novartis Investigative Site
RECRUITING

Berlin, 13125, Germany
Novartis Investigative Site
RECRUITING

Bottrop, 46236, Germany
Novartis Investigative Site
WITHDRAWN

Böblingen, 71032, Germany
Novartis Investigative Site
RECRUITING

Dessau, 06847, Germany
Novartis Investigative Site
RECRUITING

Erlangen, 91054, Germany
Novartis Investigative Site
RECRUITING

Essen, 45147, Germany
Novartis Investigative Site
WITHDRAWN

Hamburg, 20246, Germany
Novartis Investigative Site
RECRUITING

Kiel, 24105, Germany
Novartis Investigative Site
RECRUITING

Leipzig, 04277, Germany
Novartis Investigative Site
WITHDRAWN

Mainz, 55131, Germany
Novartis Investigative Site
RECRUITING

München, 80637, Germany
Novartis Investigative Site
RECRUITING

Ravensburg, 88214, Germany
Novartis Investigative Site
RECRUITING

Hong Kong, 999077, Hong Kong
Novartis Investigative Site
RECRUITING

Kowloon, 999077, Hong Kong
Novartis Investigative Site
RECRUITING

Tuenmen, 999077, Hong Kong
Novartis Investigative Site
ACTIVE_NOT_RECRUITING

Hyderabad, Andhra Pradesh, 500034, India
Novartis Investigative Site
ACTIVE_NOT_RECRUITING

Bangalore, Karnataka, 560017, India
Novartis Investigative Site
ACTIVE_NOT_RECRUITING

Mumbai, Maharashtra, 400 012, India
Novartis Investigative Site
ACTIVE_NOT_RECRUITING

Pune, Maharasthra, 411028, India
Novartis Investigative Site
ACTIVE_NOT_RECRUITING

New Delhi, National Capital Territory of Delhi, 110029, India
Novartis Investigative Site
ACTIVE_NOT_RECRUITING

Bhubaneswar, Odisha, 751007, India
Novartis Investigative Site
ACTIVE_NOT_RECRUITING

Chennai, Tamil Nadu, 600 035, India
Novartis Investigative Site
ACTIVE_NOT_RECRUITING

Kolkata, West Bengal, 700054, India
Novartis Investigative Site
ACTIVE_NOT_RECRUITING

Ahmedabad, 380054, India
Novartis Investigative Site
RECRUITING

Beersheba, 8457108, Israel
Novartis Investigative Site
RECRUITING

Petah Tikva, 4941492, Israel
Novartis Investigative Site
RECRUITING

Ramat Gan, 5265601, Israel
Novartis Investigative Site
RECRUITING

Tel Aviv, 6423906, Israel
Novartis Investigative Site
RECRUITING

Alc Cuahutemoc, Mexico City, 06720, Mexico
Novartis Investigative Site
RECRUITING

Tlalpan, Mexico City, 14080, Mexico
Novartis Investigative Site
RECRUITING

Monterrey, Nuevo León, 64460, Mexico
Novartis Investigative Site
RECRUITING

Coimbra, 3000-075, Portugal
Novartis Investigative Site
RECRUITING

Lisbon, 1400-038, Portugal
Novartis Investigative Site
RECRUITING

Lisbon, 1649-035, Portugal
Novartis Investigative Site
RECRUITING

Porto, 4100-180, Portugal
Novartis Investigative Site
RECRUITING

Porto, 4200 319, Portugal
Novartis Investigative Site
RECRUITING

Porto, 4200-072, Portugal
Novartis Investigative Site
RECRUITING

Bundang Gu, Gyeonggi-do, 13620, South Korea
Novartis Investigative Site
RECRUITING

Gyeonggi-do, Korea, 10408, South Korea
Novartis Investigative Site
RECRUITING

Incheon, Korea, 405 760, South Korea
Novartis Investigative Site
RECRUITING

Seoul, Korea, 02841, South Korea
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RECRUITING

Seoul, Yangcheon Gu, 07985, South Korea
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RECRUITING

Seongnam Gyeonggi, 463-712, South Korea
Novartis Investigative Site
RECRUITING

Seoul, 03080, South Korea
Novartis Investigative Site
RECRUITING

Seoul, 03722, South Korea
Novartis Investigative Site
RECRUITING

Seoul, 05505, South Korea
Novartis Investigative Site
RECRUITING

Seoul, 06273, South Korea
Novartis Investigative Site
RECRUITING

Seoul, 06351, South Korea
Novartis Investigative Site
RECRUITING

Seoul, 06591, South Korea
Novartis Investigative Site
RECRUITING

Hualien City, 970, Taiwan
Novartis Investigative Site
RECRUITING

Kaohsiung City, 80756, Taiwan
Novartis Investigative Site
RECRUITING

Tainan, 71004, Taiwan
Novartis Investigative Site
RECRUITING

Taipei, 10002, Taiwan
Novartis Investigative Site
RECRUITING

Taipei, 11490, Taiwan
Novartis Investigative Site
RECRUITING

Sakarya, Adapazari, 54290, Turkey (Türkiye)
Novartis Investigative Site
RECRUITING

Ankara, Bilkent-Cankaya, 06800, Turkey (Türkiye)
Novartis Investigative Site
RECRUITING

Istanbul, Fatih, 34098, Turkey (Türkiye)
Novartis Investigative Site
RECRUITING

Istanbul, Kadikoy, 34722, Turkey (Türkiye)
Novartis Investigative Site
RECRUITING

Izmir, Karsiyaka, 35575, Turkey (Türkiye)
Novartis Investigative Site
RECRUITING

Denizli, Kinikli, 20070, Turkey (Türkiye)
Novartis Investigative Site
RECRUITING

Antalya, Konyaalti, 07070, Turkey (Türkiye)
Novartis Investigative Site
RECRUITING

Istanbul, Sariyer, 34457, Turkey (Türkiye)
Novartis Investigative Site
RECRUITING

Ankara, Sihhiye-Altindag, 06230, Turkey (Türkiye)
Novartis Investigative Site
RECRUITING

Diyarbakır, Sur, 21280, Turkey (Türkiye)
Novartis Investigative Site
RECRUITING

Istanbul, Uskudar, 34662, Turkey (Türkiye)
Novartis Investigative Site
RECRUITING

Ankara, Yenimahalle, 06200, Turkey (Türkiye)
Novartis Investigative Site
RECRUITING

Ankara, Yenimahalle, 06500, Turkey (Türkiye)
Novartis Investigative Site
RECRUITING

Adana, Yuregir, 01230, Turkey (Türkiye)
Novartis Investigative Site
RECRUITING

Ankara, 06520, Turkey (Türkiye)
Novartis Investigative Site
RECRUITING

Istanbul, 34147, Turkey (Türkiye)
Novartis Investigative Site
RECRUITING

Izmir, 35100, Turkey (Türkiye)
Novartis Investigative Site
RECRUITING

Kecioren Ankara, 06010, Turkey (Türkiye)
Novartis Investigative Site
RECRUITING

Konya, 42080, Turkey (Türkiye)
Novartis Investigative Site
RECRUITING

Samsun, 55200, Turkey (Türkiye)
Ocala Research Institute, Inc
RECRUITING

Ocala, Florida, 34474, United States
Onco Inst of Hope and Innovation
RECRUITING

Cerritos, California, 90703, United States
Oncology Associates of Oregon PC
RECRUITING

Eugene, Oregon, 97401-8122, United States
Optum Health
RECRUITING

Lake Success, New York, 11042, United States
Oregon Oncology Specialists Salem
RECRUITING

Salem, Oregon, 97301, United States
Palo Alto Medical Foundation
RECRUITING

Mountain View, California, 94040, United States
Pan Oncology
RECRUITING

Rio Piedras, 00935, Puerto Rico
Presbyterian Medical Group
RECRUITING

Albuquerque, New Mexico, 87110, United States
Providence Medical Foundation
RECRUITING

Fullerton, California, 92835, United States
Providence Regional Cancer System
RECRUITING

Lacey, Washington, 98503, United States
Queens Cancer Center of Queens Hospital
RECRUITING

Jamaica, New York, 11432, United States
Regional Medical Oncology NC
RECRUITING

Wilson, South Carolina, 27893, United States
Renown Regional Medical Center
RECRUITING

Reno, Nevada, 89502, United States
Rhode Island Hospital
RECRUITING

Providence, Rhode Island, 02903, United States
Rocky Mountain Cancer Centers
RECRUITING

Denver, Colorado, 80218, United States
Sanford Research USD Fargo
RECRUITING

Fargo, North Dakota, 58122, United States
Sanford USD Medical Center
RECRUITING

Sioux Falls, South Dakota, 57104, United States
Sarah Cannon Research Institute
RECRUITING

Nashville, Tennessee, 37203, United States
School Of Medicine
RECRUITING

Sacramento, California, 95817, United States
Sharp Rees Stealy Medical Group Inc
RECRUITING

San Diego, California, 92101, United States
Summit Cancer Care PC
RECRUITING

Savannah, Georgia, 31405, United States
Summit Health
RECRUITING

Florham Park, New Jersey, 07932, United States
Sutter Inst Medical Research
RECRUITING

Sacramento, California, 95816-5199, United States
Texas Oncology P A Plano East
RECRUITING

Plano, Texas, 75075, United States
Texas Oncology PA Tyler
RECRUITING

Tyler, Texas, 75702, United States
The Valley Hospital
RECRUITING

Ridgewood, New Jersey, 07450, United States
UC Irvine Medical Center
RECRUITING

Orange, California, 92868, United States
Univ of Pittsburg Med Ctr Pinnacle
RECRUITING

Harrisburg, Pennsylvania, 17109, United States
University Cancer and Blood Center LLC
RECRUITING

Athens, Georgia, 30607, United States
University of Iowa Health Care
RECRUITING

Waukee, Iowa, 50263, United States
University of Kansas Cancer Center
RECRUITING

Westwood, Kansas, 66205, United States
University of Texas
RECRUITING

Houston, Texas, 77030-4099, United States
Valley Medical Center Research
RECRUITING

Renton, Washington, 98055, United States
Virginia Oncology Associates
RECRUITING

Norfolk, Virginia, 23502, United States
WA Uni School Of Med
RECRUITING

St Louis, Missouri, 63110, United States
Western Reg MC-COH Phoenix
RECRUITING

Goodyear, Arizona, 85338, United States
Willis-Knighton Cancer Center
RECRUITING

Shreveport, Louisiana, 71103, United States

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