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Search / Trial NCT03988114

A Study of Abemaciclib (LY2835219) in Participants With HR+, HER2- Advanced Breast Cancer

Launched by ELI LILLY AND COMPANY · Jun 12, 2019

Trial Information

Current as of July 04, 2025

Withdrawn

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Participants must have completed (neo) adjuvant endocrine therapy and have cancer return after at least 12 months or have de novo cancer that has spread to other organs at diagnosis
  • * Participants must have 1 or more of the following:
  • A high grade tumor in tissue
  • Negative progesterone receptor (PR) status
  • Have cancer that has spread to the liver
  • Have a treatment-free interval (TFI) \<36 months
  • Participants must have HR+, HER2- breast cancer
  • Participants must have adequate organ function
  • Exclusion Criteria:
  • Participants must not have cancer that has spread to other organs that has severely affected their function
  • Participants must not have cancer that has spread to the brain that is unstable or untreated
  • Participants must not have received endocrine therapy in the metastatic setting
  • Participants must not have known active infection
  • Participants must not have received prior endocrine therapy and had disease return within 12 months from completion of treatment
  • Participants must not have received prior treatment with any cyclin-dependent kinase (CDK) 4 \& 6 inhibitor or everolimus

About Eli Lilly And Company

Eli Lilly and Company is a global healthcare leader dedicated to creating innovative medicines that improve patient outcomes across a range of therapeutic areas, including diabetes, oncology, immunology, and neurodegenerative diseases. With a rich history of scientific research and a commitment to advancing healthcare, Lilly invests significantly in clinical trials to develop new treatments and enhance existing therapies. The company prioritizes patient safety and ethical standards in its clinical research, fostering collaboration with healthcare professionals and stakeholders to ensure the delivery of high-quality, evidence-based solutions that address unmet medical needs worldwide.

Locations

Harvey, Illinois, United States

Palm Springs, California, United States

Fort Myers, Florida, United States

Colorado Springs, Colorado, United States

Lewiston, Maine, United States

Tyler, Texas, United States

Norfolk, Virginia, United States

Henderson, Nevada, United States

Fort Worth, Texas, United States

The Woodlands, Texas, United States

Austin, Texas, United States

Niles, Illinois, United States

York, Maine, United States

Orange, California, United States

Torrance, California, United States

Taichung, , Taiwan

Taichung, , Taiwan

Tainan, , Taiwan

Taipei, , Taiwan

Amarillo, Texas, United States

West Palm Beach, Florida, United States

Highland, California, United States

Indianapolis, Indiana, United States

Plano, Texas, United States

Fountain Valley, California, United States

Charleston, South Carolina, United States

Dallas, Texas, United States

Arlington, Texas, United States

Plano, Texas, United States

Dallas, Texas, United States

Padova, , Italy

Mcallen, Texas, United States

Bedford, Texas, United States

Abilene, Texas, United States

Houston, Texas, United States

Savannah, Georgia, United States

Pensacola, Florida, United States

Nashville, Tennessee, United States

Nashville, Tennessee, United States

Saint Petersburg, Florida, United States

Milano, , Italy

Dallas, Texas, United States

Monterey, California, United States

Johnson City, New York, United States

Paris, Texas, United States

Kansas City, Missouri, United States

Newark, Delaware, United States

Wien, , Austria

Ottignies, , Belgium

Caba, Ciudad Autonoma Buenos Aires, Argentina

San Juan, , Argentina

Graz, Steiermark, Austria

Clearwater, Florida, United States

Winchester, Virginia, United States

Salem, Virginia, United States

Weston, Florida, United States

Sherman, Texas, United States

Omaha, Nebraska, United States

Bayamon, , Puerto Rico

Fresno, California, United States

Ponce, , Puerto Rico

Leipzig, Sachsen, Germany

Santa Barbara, California, United States

Bologna, , Italy

Candiolo, Torino, Italy

Tallahassee, Florida, United States

Ijui, Rio Grande Do Sul, Brazil

Barretos, Sao Paulo, Brazil

Sao Jose Rio Preto, Sao Paulo, Brazil

São Paulo, , Brazil

Wichita Falls, Texas, United States

Salzburg, , Austria

Genova, , Italy

Daphne, Alabama, United States

Tempe, Arizona, United States

San Marcos, California, United States

Saint Augustine, Florida, United States

Mesquite, Texas, United States

Webster, Texas, United States

Fredericksburg, Virginia, United States

Berazategui, Buenos Aires, Argentina

Ciudad Autonoma Buenos Aires, , Argentina

Salta, , Argentina

Innsbruck, Tirol, Austria

Brugge, , Belgium

Haine St. Paul, , Belgium

Ieper, , Belgium

Londrina, Parana, Brazil

Porto Alegre, Rio Grande Do Sul, Brazil

Rio De Janeiro, Rj, Brazil

Augsburg, Bavaria, Germany

Napoli, Naples, Italy

Taichung, , Taiwan

Flower Mound, Texas, United States

Lone Tree, Colorado, United States

Midland, Texas, United States

Caba, Buenos Aires, Argentina

Kaohsiung, , Taiwan

Houston, Texas, United States

Paramus, New Jersey, United States

Horsham, Pennsylvania, United States

Dallas, Texas, United States

Dallas, Texas, United States

El Paso, Texas, United States

Mckinney, Texas, United States

San Antonio, Texas, United States

Saint George, Utah, United States

San Miguel De Tucumán, Tucuman, Argentina

Tucumain, , Argentina

Salvador, Bahia, Brazil

Lajeado, Rs, Brazil

Santo Andre, Sp, Brazil

Ribeirao Preto, São Paulo, Brazil

Rio De Janeiro, , Brazil

Sao Paulo, , Brazil

São Paulo, , Brazil

São Paulo, , Brazil

Paderborn, , Germany

Udine, , Italy

Taipei, , Taiwan

Ribeirao Preto, , Brazil

Patients applied

0 patients applied

Trial Officials

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Study Director

Eli Lilly and Company

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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