An Efficacy and Safety Study of JNJ-56021927 (Apalutamide) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS
ATLAS: A Randomized, Double-blind, Placebo-controlled Phase 3 Study of JNJ-56021927 in Subjects With High-risk, Localized or Locally Advanced Prostate Cancer Receiving Treatment With Primary Radiation Therapy
4 other identifiers
interventional
1,503
23 countries
263
Brief Summary
The purpose of this study is to determine if apalutamide plus gonadotropin releasing hormone (GnRH) agonist in participants with high-risk, localized or locally advanced prostate cancer receiving primary radiation therapy (RT) results in an improvement of metastasis-free survival (MFS) based on conventional imaging assessed by blinded independent central review (BICR).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2015
Longer than P75 for phase_3
263 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 21, 2015
CompletedFirst Posted
Study publicly available on registry
August 24, 2015
CompletedStudy Start
First participant enrolled
November 19, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 29, 2028
April 13, 2026
April 1, 2026
10.6 years
August 21, 2015
April 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Metastasis-Free Survival (MFS)
MFS is defined as the time from randomization to the date of the first occurrence of radiographic bone or soft tissue distant metastasis based on conventional imaging assessed by blinded independent central review (BICR), histopathologic diagnosis of distant metastasis, or death from any cause, whichever occurs first.
108 Months
Secondary Outcomes (8)
Event-Free Survival (EFS) Based on Conventional Imaging Assessed By BICR
108 Months
Time to PSA Progression
108 Months
MFS Based on Conventional Imaging or Prostate-Specific Membrane Antigen (PSMA)-Positron Emission Tomography (PET) Imaging Assessed by BICR
108 Months
No Evidence of Disease (NED) Based on Conventional Imaging or PSMA PET Imaging Assessed by BICR
108 Months
Overall Survival (OS)
108 Months
- +3 more secondary outcomes
Study Arms (2)
Apalutamide
EXPERIMENTALParticipants will receive apalutamide (240 mg), by mouth, once daily for overall 30 months, plus bicalutamide placebo, by mouth, once daily, for four months from randomization. All participants are treated with gonadotropin releasing hormone (GnRH) agonist for 30 months from randomization and radiation therapy to the prostate started at about 8 weeks after randomization.
Control group
ACTIVE COMPARATORParticipants will receive apalutamide placebo, by mouth, once daily for overall 30 months, plus bicalutamide (50 mg), by mouth, once daily, for four months from randomization. All participants are treated with gonadotropin releasing hormone (GnRH) agonist for 30 months from randomization and radiation therapy to the prostate started at about 8 weeks after randomization.
Interventions
Eligibility Criteria
You may qualify if:
- Age \>= 18 years
- Indicated and planned to receive primary radiation therapy for prostate cancer
- Histologically confirmed adenocarcinoma of an intact prostate, and 1 of the following at diagnosis: 1) Gleason score \>=8 and \>=cT2c, 2) Gleason score 7, PSA \>=20 nanogram per milliliters (ng/mL), and \>=cT2c
- Charlson index (CCI) \<=3
- An Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) grade of 0 or 1
- Adequate organ function: (1) aspartate aminotransferase (AST), alanine aminotransferase (ALT), within normal limits (WNL), (2) serum creatinine less than (\<) 1.5 milligram/deciliter (mg/dL) (\<133 micromoles/Liter \[mcmol/L\]), (3) platelets greater than or equal to (\>=)140,000/microLiter (mcL), independent of transfusion and/or growth factors within 3 months prior to randomization, (4) Hemoglobin \>= 12.0 gram/deciliter (g/dL) (7.4 millimloes \[mmol\], independent of transfusion and/or growth factors within 3 months prior to randomization
- Participants who are sexually active (even men with vasectomies) and willing to use a condom and agree not to donate sperm during the trial
- Signed, written, informed consent
- Be able to swallow whole study drug tablets
You may not qualify if:
- Prior treatment with gonadotropin releasing hormone (GnRH) analogue or anti-androgen or both for \>3 months prior to randomization
- Bilateral orchiectomy
- History of pelvic radiation
- Prior systemic (example \[e.g.\], chemotherapy) or local (e.g. radical prostatectomy, cryotherapy) treatment for prostate cancer
- History of seizure or any condition that may predispose to seizure (including, but not limited to prior stroke, transient ischemic attack or loss of consciousness \<= 1 year prior to randomization; brain arteriovenous malformation; or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect)
- Prior treatment with enzalutamide, abiraterone acetate, orteronel, galeterone, ketoconazole, aminoglutethimide, estrogens, megestrol acetate, and progestational agents (including cyproterone acetate) for prostate cancer
- Prior treatment with radiopharmaceutical agents (e.g., strontium-89) or immunotherapy (e.g., sipuleucel-T) for prostate cancer
- Prior treatment with systemic glucocorticoids ≤4 weeks prior to randomization or is expected to require long-term use of corticosteroids during the study
- Use of 5-alpha reductase inhibitors (e.g., dutasteride, finasteride) \<=4 weeks prior to randomization
- Use of any investigational agent \<=4 weeks prior to randomization
- Current chronic use of opioid analgesics for \>=3 weeks for oral or \>= 7 days for non-oral formulations
- Major surgery \<=4 weeks prior to randomization
- Current or prior treatment with anti-epileptic medications for the treatment of seizures
- Gastrointestinal conditions affecting absorption
- Known or suspected contraindications or hypersensitivity to apalutamide, bicalutamide or GnRH agonists or any of the components of the formulations
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (263)
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Homewood, Alabama, United States
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Chandler, Arizona, United States
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Scottsdale, Arizona, United States
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Tucson, Arizona, United States
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Bakersfield, California, United States
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Los Angeles, California, United States
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Orange, California, United States
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San Bernardino, California, United States
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San Diego, California, United States
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San Francisco, California, United States
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Aurora, Colorado, United States
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Denver, Colorado, United States
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Middlebury, Connecticut, United States
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Bradenton, Florida, United States
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Daytona Beach, Florida, United States
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Fort Myers, Florida, United States
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Hialeah, Florida, United States
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Lakewood Rch, Florida, United States
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Naples, Florida, United States
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Plantation, Florida, United States
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Meridian, Idaho, United States
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Evergreen Park, Illinois, United States
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Harvey, Illinois, United States
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Jeffersonville, Indiana, United States
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Wichita, Kansas, United States
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Ashland, Kentucky, United States
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New Orleans, Louisiana, United States
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Shreveport, Louisiana, United States
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Scarborough, Maine, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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St Louis, Missouri, United States
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Morristown, New Jersey, United States
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Albany, New York, United States
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Brooklyn, New York, United States
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New York, New York, United States
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Poughkeepsie, New York, United States
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Rochester, New York, United States
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Syracuse, New York, United States
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The Bronx, New York, United States
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Cary, North Carolina, United States
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Raleigh, North Carolina, United States
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Portland, Oregon, United States
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Springfield, Oregon, United States
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Bala-Cynwyd, Pennsylvania, United States
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Bryn Mawr, Pennsylvania, United States
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Lancaster, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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East Greenwich, Rhode Island, United States
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Charleston, South Carolina, United States
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Myrtle Beach, South Carolina, United States
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Nashville, Tennessee, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Fairfax, Virginia, United States
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Virginia Beach, Virginia, United States
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Burien, Washington, United States
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Spokane, Washington, United States
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Morgantown, West Virginia, United States
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Buenos Aires, Argentina
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C.a.b.a., Argentina
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Caba, Argentina
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Pergamino, Argentina
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Rosario, Argentina
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San Salvador de Jujuy, Argentina
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Aalst, Belgium
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Antwerp, Belgium
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Bonheiden, Belgium
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Brussels, Belgium
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Haine-St-Paul, Belgium
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Leuven, Belgium
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Liège, Belgium
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Namur, Belgium
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Roeselare, Belgium
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Sint-Niklaas, Belgium
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Turnhout, Belgium
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Barretos, Brazil
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Belo Horizonte, Brazil
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Campinas, Brazil
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Curitiba, Brazil
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Florianópolis, Brazil
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Goiânia, Brazil
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Ijuí, Brazil
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Natal, Brazil
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Porto Alegre, Brazil
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Ribeirão Preto, Brazil
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Rio de Janeiro, Brazil
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Salvador, Brazil
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Santo André, Brazil
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São José do Rio Preto, Brazil
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São Paulo, Brazil
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Sorocaba, Brazil
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Calgary, Alberta, Canada
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Surrey, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Victoria, British Columbia, Canada
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London, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Gatineau, Quebec, Canada
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Laval, Quebec, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Beijing, China
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Chongqing, China
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Guangzhou, China
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Nanchang, China
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Nanjing, China
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Ningbo, China
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Shanghai, China
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Wuhan, China
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Xi'an, China
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Hradec Králove, Czechia
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Liberec, Czechia
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Nový Jicin, Czechia
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Olomouc, Czechia
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Opava, Czechia
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Pardubice, Czechia
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Prague, Czechia
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Zlín, Czechia
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Amiens, France
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Angers, France
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Avignon, France
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Bayonne, France
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Besançon, France
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Bordeaux, France
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Brest, France
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Dijon, France
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Évry-Courcouronnes, France
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Hyères, France
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La Tronche, France
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Le Mans, France
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Lille, France
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Marseille, France
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Marseilli, France
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Montpellier, France
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Neuilly-sur-Seine, France
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Paris, France
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Ris-Orangis, France
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Saint-Brieuc, France
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Saint-Herblain, France
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Saint-Mandé, France
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Saint-Priest-en-Jarez, France
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Strasbourg, France
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Toulouse, France
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Tours, France
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Vandœuvre-lès-Nancy, France
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Villejuif, France
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Braunschweig, Germany
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Chemnitz, Germany
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Dessau, Germany
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Frankfurt, Germany
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Gronau, Germany
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Jena, Germany
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Münster, Germany
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Nürtingen, Germany
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Ulm, Germany
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Weiden/Opf, Germany
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Beer Yaakov, Israel
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Beersheba, Israel
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Haifa, Israel
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Jerusalem, Israel
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Kfar Saba, Israel
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Petah Tikva, Israel
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Ramat Gan, Israel
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Tel Aviv, Israel
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George Town, Malaysia
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Kuala Lumpur, Malaysia
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Kuching, Malaysia
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Putrajaya, Malaysia
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Culiacán, Mexico
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Guadalajara, Mexico
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León, Mexico
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México, Mexico
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Morelia, Mexico
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Zapopan, Mexico
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Alkmaar, Netherlands
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Amsterdam, Netherlands
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Nijmegen, Netherlands
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Rotterdam, Netherlands
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The Hague, Netherlands
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Bialystok, Poland
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Bydgoszcz, Poland
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Gdynia, Poland
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Gliwice, Poland
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Kielce, Poland
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Lodz, Poland
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Olsztyn, Poland
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Poznan, Poland
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Wałbrzych, Poland
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Bucharest, Romania
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Cluj-Napoca, Romania
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Floreşti, Romania
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Iași, Romania
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Otopeni, Romania
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Ploieşti, Romania
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Sibiu, Romania
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Târgu Mureş, Romania
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Timișoara, Romania
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Barnaul, Russia
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Ivanovo, Russia
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Moscow, Russia
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Nizhny Novgorod, Russia
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Obninsk, Russia
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Omsk, Russia
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Pyatigorsk, Russia
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Rostov-on-Don, Russia
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Ryazan, Russia
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Saint Petersburg, Russia
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Saransk, Russia
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Tambov, Russia
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Tyumen, Russia
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Ufa, Russia
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Vologda, Russia
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Buk Gu, South Korea
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Gyeonggi-do, South Korea
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Jeollanam-do, South Korea
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Seoul, South Korea
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Suwon, South Korea
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Barakaldo, Spain
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Barcelona, Spain
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Castellon, Spain
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L'Hospitalet de Llobregat, Spain
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Las Palmas de Gran Canaria, Spain
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Madrid, Spain
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Málaga, Spain
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Reus, Spain
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Santiago de Compostela, Spain
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Seville, Spain
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Örebro, Sweden
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Stockholm, Sweden
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Umeå, Sweden
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Kaohsiung City, Taiwan
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Taichung, Taiwan
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Tainan, Taiwan
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Taipei, Taiwan
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Taoyuan District, Taiwan
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Adana, Turkey (Türkiye)
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Ankara, Turkey (Türkiye)
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Edirne, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Izmir, Turkey (Türkiye)
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Kayseri, Turkey (Türkiye)
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Kocaeli, Turkey (Türkiye)
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Dnipro, Ukraine
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Khakhiv, Ukraine
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Kyiv, Ukraine
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Lviv, Ukraine
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Aberdeen, United Kingdom
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Birmingham, United Kingdom
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Bristol, United Kingdom
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Derby, United Kingdom
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Glasgow, United Kingdom
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Oxford, United Kingdom
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Plymouth, United Kingdom
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Preston, United Kingdom
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Sheffield, United Kingdom
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Sutton, United Kingdom
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Wolverhampton, United Kingdom
Related Publications (1)
Poterala JE, Wisinski KB. Abbreviated endocrine therapy duration for low estrogen receptor-positive breast cancer: The counter to extended endocrine therapy. Cancer. 2022 May 1;128(9):1724-1726. doi: 10.1002/cncr.34158. Epub 2022 Feb 25. No abstract available.
PMID: 35213039DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Aragon Pharmaceuticals, Inc. Clinical Trial
Aragon Pharmaceuticals, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2015
First Posted
August 24, 2015
Study Start
November 19, 2015
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
December 29, 2028
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share