A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer
Launched by ELI LILLY AND COMPANY · Apr 4, 2014
Trial Information
Current as of August 19, 2025
Active, not recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the effects of a medication called abemaciclib when combined with fulvestrant in women who have hormone receptor positive, HER2 negative advanced breast cancer. The main goal is to see if this combination can help women live longer without their cancer getting worse compared to those receiving fulvestrant alone. Women in the trial will be randomly assigned to receive either the combination treatment or a placebo (a treatment without active medication) in a ratio of 2 to 1. The study will last about 9 months for each person.
To participate in this trial, women must have advanced breast cancer that is hormone receptor positive and HER2 negative, and they should not have received certain prior treatments for their cancer. Eligible participants should also be postmenopausal, meaning they are no longer having menstrual periods. During the trial, participants can expect regular check-ups to monitor their health and the effects of the treatment. It’s important to know that this trial is currently active but not recruiting new participants.
Gender
FEMALE
Eligibility criteria
- • Inclusion Criteria
- • Have a diagnosis of HR+, HER2- breast cancer
- * Have locally advanced disease not amenable to curative treatment by surgery or metastatic disease. In addition, participants must fulfill 1 of the following criteria:
- • relapsed with radiologic evidence of progression while receiving neoadjuvant or adjuvant endocrine therapy, with no subsequent endocrine therapy received following progression
- • relapsed with radiologic evidence of progression within 1 year from completion of adjuvant endocrine therapy, with no subsequent endocrine therapy received following progression
- • relapsed with radiologic evidence of progression more than 1 year from completion of adjuvant endocrine therapy and then subsequently relapsed with radiologic evidence of progression after receiving treatment with either an antiestrogen or an aromatase inhibitor as first-line endocrine therapy for metastatic disease. Participants may not have received more than 1 line of endocrine therapy or any prior chemotherapy for metastatic disease
- • presented de novo with metastatic disease and then relapsed with radiologic evidence of progression after receiving treatment with either an antiestrogen or an aromatase inhibitor as first line endocrine therapy for metastatic disease. Participants may not have received more than 1 line of endocrine therapy or any prior chemotherapy for metastatic disease
- • for the endocrine naïve cohort: Must not have received prior endocrine therapy in current or prior disease setting
- • Have postmenopausal status due to either surgical/natural menopause or ovarian suppression (initiated at least 28 days prior to Day 1 of Cycle 1) with a gonadotropin-releasing hormone (GnRH) agonist such as goserelin
- • Have a negative serum pregnancy test at baseline (within 14 days prior to randomization) and agree to use medically approved precautions to prevent pregnancy during the study and for 12 weeks following the last dose of abemaciclib if postmenopausal status is due to ovarian suppression with a GnRH agonist
- • Have either measurable disease or nonmeasurable bone only disease
- • Have a performance status ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale
- • Have discontinued previous therapies for cancer (including specifically, aromatase inhibitors, anti-estrogens, chemotherapy, radiotherapy, and immunotherapy) for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving study drug, and recovered from the acute effects of therapy (until the toxicity resolves to either baseline or at least Grade 1) except for residual alopecia or peripheral neuropathy
- • Exclusion Criteria
- • Are currently receiving an investigational drug in a clinical trial or participating in any other type of medical research judged not to be scientifically or medically compatible with this study
- • Have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis visceral crisis is not the mere presence of visceral metastases but implies severe organ dysfunction as assessed by symptoms and signs, laboratory studies, and rapid progression of the disease
- • Have clinical evidence or history of central nervous system metastasis
- • Have received prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy), fulvestrant, everolimus, or any CDK4/6 inhibitor. For the endocrine naïve cohort: In addition, have received treatment with any prior endocrine therapy
- • Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days prior to randomization of study drug for a nonmyelosuppressive or myelosuppressive agent, respectively
- • Have received recent (within 28 days prior to randomization) yellow fever vaccination
- • Have had major surgery within 14 days prior to randomization of study drug to allow for post-operative healing of the surgical wound and site(s)
- • Have a personal history within the last 12 months of any of the following conditions: syncope of cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest
- • Have inflammatory breast cancer or a history of any other cancer (except nonmelanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission with no therapy for a minimum of 3 years
- • Have received an autologous or allogeneic stem-cell transplant
- • Have active bacterial or fungal infection, or detectable viral infection
- • Have initiated bisphosphonates or approved Receptor activator of nuclear factor kappa-B (RANK) ligand targeted agents \<7 days prior to randomization
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Houston, Texas, United States
New York, New York, United States
Toronto, Ontario, Canada
New York, New York, United States
Madrid, , Spain
Saint Louis, Missouri, United States
Rochester, New York, United States
Boston, Massachusetts, United States
Tyler, Texas, United States
Murcia, , Spain
Rome, Georgia, United States
Fort Lauderdale, Florida, United States
Tampa, Florida, United States
Athens, Georgia, United States
New York, New York, United States
Salt Lake City, Utah, United States
Madrid, , Spain
Calgary, Alberta, Canada
Germantown, Tennessee, United States
Kyoto, , Japan
Taipei, , Taiwan
Austin, Texas, United States
Kennewick, Washington, United States
Fayetteville, Arkansas, United States
Joplin, Missouri, United States
Lebanon, New Hampshire, United States
Fort Myers, Florida, United States
Liège, , Belgium
Billings, Montana, United States
Burlington, Vermont, United States
Baltimore, Maryland, United States
Chania, , Greece
Padova, , Italy
Murcia, , Spain
Bellflower, California, United States
Lebanon, New Hampshire, United States
Lleida, , Spain
Nagoya, Aichi, Japan
Kashiwa, Chiba, Japan
Sapporo, Hokkaido, Japan
Nishinomiya, Hyogo, Japan
Chuo Ku, Tokyo, Japan
Monterrey, , Mexico
Seoul, , Korea, Republic Of
Taipei, , Taiwan
London, Ontario, Canada
Seoul, , Korea, Republic Of
Leuven, , Belgium
Barcelona, , Spain
Taichung, , Taiwan
Jonesboro, Arkansas, United States
Madrid, , Spain
Taichung, , Taiwan
Athens, Georgia, United States
Miami, Florida, United States
Leuven, , Belgium
Tübingen, , Germany
Bologna, , Italy
Edegem, , Belgium
Lleida, , Spain
Herlev, , Denmark
Le Mans, , France
Taichung, , Taiwan
Kagoshima, , Japan
Patras, , Greece
Leon, , Mexico
Anderson, Indiana, United States
Besancon, , France
Heraklion, , Greece
Arkhangelsk, , Russian Federation
Tampere, , Finland
Moscow, , Russian Federation
Niigata Shi, Niigata, Japan
Elche, Alicante, Spain
Barcelona, , Spain
Brussel, , Belgium
Seoul, , Korea, Republic Of
Rome, , Italy
Seongnam, , Korea, Republic Of
Saint Louis, Missouri, United States
Quincy, Illinois, United States
Valencia, , Spain
Kyoto, , Japan
Roskilde, , Denmark
Ludwigsburg, , Germany
Roskilde, , Denmark
Seongnam, Gyeonggi Do, Korea, Republic Of
Augsburg, , Germany
Lansing, Michigan, United States
Matsuyama, Ehime, Japan
Monterrey, Nuevo León, Mexico
Kurralta Park, South Australia, Australia
Taoyuan, , Taiwan
Elche, , Spain
Kaohsiung, , Taiwan
Kuei Shan Hsiang, , Taiwan
Plano, Texas, United States
Patras, , Greece
Ulsan Si, , Korea, Republic Of
Incheon, , Korea, Republic Of
Turku, , Finland
Aalborg, , Denmark
Billings, Montana, United States
Fukuoka, , Japan
Edegem, Antwerpen, Belgium
Taipei, , Taiwan
Gdansk, , Poland
Aurora, Colorado, United States
Le Mans, , France
Southport, Queensland, Australia
Bialystok, , Poland
Incheon, , Korea, Republic Of
Basel, , Switzerland
Houston, Texas, United States
Kennewick, Washington, United States
Kaohsiung, , Taiwan
Lodz, , Poland
Sioux Falls, South Dakota, United States
Cluj Napoca, , Romania
La Chaussee Saint Victor, , France
Hamburg, , Germany
Tijuana, , Mexico
Mexico City, , Mexico
Saint Petersburg, Florida, United States
La Jolla, California, United States
San Francisco, California, United States
Seoul, , Korea, Republic Of
Ludwigsburg, Baden Württemberg, Germany
Springdale, Arkansas, United States
Saint Petersburg, Florida, United States
New York, New York, United States
Oulu, , Finland
Tijuana, Baja California, Mexico
Heraklion, , Greece
Padova, , Italy
West Palm Beach, Florida, United States
Osaka, , Japan
Nashville, Tennessee, United States
Bedford, Texas, United States
San Marcos, California, United States
Basel, Basel Stadt, Switzerland
Chungbuk, , Korea, Republic Of
Kaohsiung, , Taiwan
Turku, , Finland
Cheongju Si, , Korea, Republic Of
Koto Ku, , Japan
Niigata, , Japan
Tulsa, Oklahoma, United States
Munich, , Germany
Ulsan, , Korea, Republic Of
Salem, Virginia, United States
Chiba, , Japan
Seoul, , Korea, Republic Of
Gyeonggi Do, , Korea, Republic Of
Minneapolis, Minnesota, United States
Stanford, California, United States
Fort Lauderdale, Florida, United States
Kansas City, Missouri, United States
Omaha, Nebraska, United States
New York, New York, United States
Winston Salem, North Carolina, United States
Sioux Falls, North Dakota, United States
Sioux Falls, North Dakota, United States
Memphis, Tennessee, United States
Fort Worth, Texas, United States
Houston, Texas, United States
The Woodlands, Texas, United States
Walla Walla, Washington, United States
East Bentleigh, , Australia
Kurralta Park, , Australia
South Brisbane, , Australia
Southport, , Australia
Subiaco, , Australia
Brussel, , Belgium
Calgary, Alberta, Canada
London, Ontario, Canada
Toronto, Ontario, Canada
Clermont Ferrand, , France
Ludwigsburg, , Germany
Athens, , Greece
Cona, , Italy
Bunkyo Ku, , Japan
Chuo Ku, , Japan
Fukuoka, , Japan
Kashiwa, , Japan
Kawasaki, , Japan
Kitaadachi Gun, , Japan
Kurume, , Japan
Matsuyama, , Japan
Nagoya, , Japan
Nishinomiya, , Japan
Osaka, , Japan
Sapporo, , Japan
Shimotsuke, , Japan
Mexico, , Mexico
Nuevo Leon, , Mexico
Wieliszew, , Poland
Bayamon, , Puerto Rico
Bucharest, , Romania
Craiova, , Romania
Kursk, , Russian Federation
St Petersburg, , Russian Federation
Genève, , Switzerland
Thun, , Switzerland
Taipei, , Taiwan
Taoyuan, , Taiwan
Tulsa, Oklahoma, United States
Hamburg, , Germany
Chiba Shi, Chiba, Japan
Subiaco, Western Australia, Australia
Kawasaki, Kanagawa, Japan
Bunkyo Ku, Tokyo, Japan
Cluj Napoca, Cluj, Romania
Kagoshima, , Japan
East Bentleigh, Victoria, Australia
Jonesboro, Arkansas, United States
Tübingen, , Germany
South Brisbane, Queensland, Australia
Aalborg, , Denmark
La Chaussee Saint Victor, , France
Kursk, , Russian Federation
Koto, Tokyo, Japan
Fort Myers, Florida, United States
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Ulsan, Ulsan Kwangyǒkshi, Korea, Republic Of
Lodz, łódzkie, Poland
Gdansk, Pomorskie, Poland
Ina Machi, Saitama, Japan
Riverside, California, United States
Toronto, Ontario, Canada
Incheon, , Korea, Republic Of
Genève, , Switzerland
Clermont Ferrand, Puy De Dôme, France
Saint Petersburg, Sankt Peterburg, Russian Federation
Mexico City, Distrito Federal, Mexico
Liège, , Belgium
Tampere, Pirkanmaa, Finland
Craiova, Dolj, Romania
Patras, Achaḯa, Greece
Arkhangelsk, Arkhangel'skaya Oblast', Russian Federation
Houston, Texas, United States
Kurume, Fukuoka, Japan
Namdong Gu, , Korea, Republic Of
Barcelona, Barcelona [Barcelona], Spain
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Copenhagen, Hovedstaden, Denmark
Madrid, Madrid, Comunidad De, Spain
Monterrey, Nuevo León, Mexico
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Helsinki, Uusimaa, Finland
Tübingen, Baden Württemberg, Germany
Cheongju Si, Chungcheongbuk Do [Chungbuk], Korea, Republic Of
Guadalajara, Jalisco, Mexico
Lleida, Lleida [Lérida], Spain
Valencia, València, Spain
Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan
Leon, Guanajuato, Mexico
Tampa, Florida, United States
München, Bayern, Germany
Augsburg, Bayern, Germany
Rome, Roma, Italy
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Namdong Gu, , Korea, Republic Of
Moscow, Moskva, Russian Federation
Saint Petersburg, Sankt Peterburg, Russian Federation
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Osaka, , Japan
Creve Coeur, Missouri, United States
Saint Peters, Missouri, United States
Bologna, , Italy
Atlantis, Florida, United States
Palm Beach Gardens, Florida, United States
Wellington, Florida, United States
Brussel, Bruxelles Capitale, Région De, Belgium
Besancon, Doubs, France
Athens, Attikí, Greece
Heraklion, Krítí, Greece
Chania, , Greece
Cona, Emilia Romagna, Italy
Shimotsuke, Tochigi, Japan
Mexico City, Distrito Federal, Mexico
Bialystok, , Poland
Bucharest, , Romania
Ivanovo, Ivanovskaya Oblast', Russian Federation
Murcia, Murcia, Región De, Spain
Thun, Berne, Switzerland
Valencia, , Spain
Clermont Ferrand, , France
Monterrey, , Mexico
Athens, , Greece
Seoul, , Korea, Republic Of
Monterrey, , Mexico
Lodz, , Poland
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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