Phase
Condition
Breast Cancer
Cancer
Treatment
GDC-4198
Abemaciclib
Giredestrant
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Histologically and/or cytologically confirmed adenocarcinoma of the breast that islocally advanced or metastatic.
Previously documented ER+ and HER2- tumor according to American Society of ClinicalOncology (ASCO)/ College of American Pathologists (CAP) or European Society ofMedical Oncology (ESMO) guidelines or any national guidelines with criteriaconforming to ASCO/CAP or ESMO guidelines.
Disease progression during or after treatment with an approved cyclin-dependentkinase 4/6 (CDK4/6) inhibitor and approved endocrine therapy (ET) in the locallyadvanced or metastatic setting.
Measurable or non-measurable evaluable, disease per Response Evaluation Criteria inSolid Tumors version 1.1 (RECIST v1.1).
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Life expectancy >= 6 months.
Exclusion
Exclusion Criteria:
Advanced, symptomatic, visceral spread that is at risk of life-threateningcomplications in the short term appropriate for treatment with cytotoxicchemotherapy at time of entry into the study, as per national or local treatmentguidelines.
Have received more than one-line of therapy for locally advanced or metastaticdisease.
Have received prior chemotherapy for metastatic breast cancer.
Treatment with an approved oral ET within 7 days prior to initiation of study drug;treatment with fulvestrant or an approved CDK4/6 inhibitor within 21 days prior toinitiation of study drug.
Malabsorption condition or other gastrointestinal (GI) conditions/surgeries that theinvestigator assesses may significantly interfere with enteral absorption
History of malignancy within 3 years prior to screening, except for cancer underinvestigation in this study and malignancies with a negligible risk of metastasis ordeath.
Known allergy or hypersensitivity to any component of the study treatments.
Study Design
Connect with a study center
St Vincent's Hospital Sydney
Darlinghurst, New South Wales 2010
AustraliaActive - Recruiting
Cancer Research SA
Adelaide, South Australia 5000
AustraliaActive - Recruiting
Hospital do Cancer de Pernambuco - HCP
Recife, Pernambuco 50040-000
BrazilActive - Recruiting
ONCOSITE Centro de Pesquisa Clínica Em Oncologia
Ijuí, Rio Grande do Sul 98700-000
BrazilActive - Recruiting
Hospital de Clinicas de Porto Alegre (HCPA) - PPDS
Porto Alegre, Rio Grande do Sul 90560-030
BrazilActive - Recruiting
Irmandade Da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul 90035-074
BrazilActive - Recruiting
Instituto Do Câncer Do Estado de São Paulo Octávio Frias de Oliveira - ICESP
São Paulo, 01246-000
BrazilActive - Recruiting
Princess Margaret Hospital
Toronto, Ontario M5G 2M9
CanadaActive - Recruiting
Fudan University Shanghai Cancer Center - Pudong Campus
Shanghai, Shanghai Municipality 201321
ChinaActive - Recruiting
Institut Jean Godinot
Reims, Champagne-Ardenne 51100
FranceActive - Recruiting
Gustave Roussy
Villejuif, Val-de-Marne 94805
FranceActive - Recruiting
Centre Francois Baclesse
Caen, 14076
FranceActive - Recruiting
Centre Oscar Lambret
Lille, 59020
FranceActive - Recruiting
Centre Eugene Marquis
Rennes, 35042
FranceActive - Recruiting
KEM - Evang. Huyssens-Stiftung Essen-Huttrop
Essen, North Rhine-Westphalia 45136
GermanyActive - Recruiting
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRST S.r.l - PPDS
Meldola, Emilia-Romagna 47014
ItalyActive - Recruiting
ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia
Brescia, Lombardy 25123
ItalyActive - Recruiting
Gangnam Severance Hospital, Yonsei University Health System
Seoul, Seoul Teugbyeolsi 6273
South KoreaActive - Recruiting
Seoul National University Bundang Hospital
Seongnam-si, 13620
South KoreaActive - Recruiting
Asan Medical Center.
Seoul, 05505
South KoreaActive - Recruiting
Seoul National University Hospital
Seoul, 03080
South KoreaActive - Recruiting
Severance Hospital, Yonsei University Health System
Seoul, 3722
South KoreaActive - Recruiting
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 06591
South KoreaActive - Recruiting
Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON
Barcelona, 08035
SpainActive - Recruiting
Hospital Beata Maria Ana
Madrid, 28007
SpainActive - Recruiting
Hospital General Universitario Gregorio Maranon
Madrid, 28007
SpainActive - Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
SpainActive - Recruiting
Hospital Beata Maria Ana
Madrid 3117735, 28007
SpainActive - Recruiting
Hospital Clinico Universitario de Valencia
Valencia, 46010
SpainActive - Recruiting
City of Hope
Duarte, California 91010
United StatesActive - Recruiting
City of Hope - Orange County Lennar Foundation Cancer Center
Irvine, California 92618
United StatesActive - Recruiting
UC San Diego Moores Cancer Center
La Jolla, California 92093-1503
United StatesActive - Recruiting
UCSF Helen Diller Family CCC
San Francisco, California 94158
United StatesActive - Recruiting
Moffitt Cancer Center
Tampa, Florida 33612
United StatesActive - Recruiting
Winship Cancer Institute of Emory University
Atlanta, Georgia 30322-1013
United StatesActive - Recruiting
City of Hope® Cancer Center Chicago
Zion, Illinois 60099
United StatesActive - Recruiting
Barbara Ann Karmanos Cancer Institute
Detroit, Maine 48201-2013
United StatesActive - Recruiting
Washington University Siteman Cancer Center
St Louis, Missouri 63110-1010
United StatesActive - Recruiting
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08901-1914
United StatesActive - Recruiting
New York Cancer & Blood Specialists
East Patchogue, New York 11772
United StatesActive - Recruiting
Levine Cancer Institute
Charlotte, North Carolina 28204
United StatesActive - Recruiting
University of Pennsylvania - Abramson Cancer Center
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
UPMC - Hillman Cancer Center
Pittsburgh, Pennsylvania 15213-3108
United StatesActive - Recruiting
Vanderbilt Breast Center at One Hundred Oaks
Nashville, Tennessee 37204-3609
United StatesActive - Recruiting
Texas Oncology (Worth) - USOR
Dallas, Texas 75246-2003
United StatesActive - Recruiting
Virginia Oncology Associates (Norfolk) - USOR
Norfolk, Virginia 23502-2800
United StatesActive - Recruiting

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