Phase
Condition
Breast Cancer
Cancer
Treatment
Abemaciclib
Anastrozole
Pembrolizumab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Have a Stage IV diagnosis of 1 of the following: Part A: NSCLC (Kirsten rat sarcomamutant [KRAS mt], PD-L1+); Part B: NSCLC (squamous histology); Part C: metastaticbreast cancer (HR+, HER2-); or Part D: locally advanced or metastatic breast cancer (HR+, HER2-)
Part A: must be chemotherapy naïve for metastatic NSCLC
Part B: must have received at least 1 prior therapy containing platinum-basedchemotherapy for advanced/metastatic NSCLC
Part C: must have previously received prior treatment with at least 1 but nomore than 2 chemotherapy regimens in the metastatic setting
Part D: cannot have received endocrine therapy or chemotherapy as treatment inthe locoregionally recurrent or metastatic breast cancer disease setting. Note:Participants may be enrolled if they received prior (neo)adjuvant chemotherapyor endocrine therapy for localized disease.
Are amenable to provide tumor tissue prior to treatment and provide tumor tissueafter treatment initiation (both mandatory).
Have presence of measurable disease as defined by Response Evaluation Criteria inSolid Tumors (RECIST 1.1).
Have a performance status (PS) ≤1 on the Eastern Cooperative Oncology Group (ECOG)scale.
Have discontinued all previous treatments for cancer and recovered from the acuteeffects of therapy.
Have an estimated life expectancy of ≥12 weeks.
For Part D: Have postmenopausal status due to surgical/natural menopause or chemicalovarian suppression (initiated 28 days prior to Day 1 of Cycle 1) with agonadotropin-releasing hormone (GnRH) agonist such as goserelin or radiation-inducedovarian suppression.
Exclusion
Exclusion Criteria:
Have a personal history of any of the following conditions: syncope of eitherunexplained or cardiovascular etiology, ventricular arrhythmia (including but notlimited to ventricular tachycardia and ventricular fibrillation), or sudden cardiacarrest. Exception: subjects with controlled atrial fibrillation for >30 days priorto study treatment are eligible.
Have central nervous system (CNS) metastasis with development of associatedneurological changes 14 days prior to receiving study drug.
Have corrected QT interval of >470 milliseconds on screening electrocardiogram (ECG).
Have history of interstitial lung disease or pneumonitis.
Have history of or active autoimmune disease, or other syndrome that requiressystemic steroids or autoimmune agents for the past 2 years.
Have received a live vaccination within 30 days of study start.
Have received prior treatment with an anti PD-1, anti-programmed death ligand 1 (PD-L1), or anti cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) agent.
For Part D Only:
Have initiated bisphosphonates or approved RANK ligand (RANK-L) targeted agents (for example, denosumab) <7 days prior to Cycle 1 Day 1.
Are currently receiving or have previously received endocrine therapy forlocoregionally recurrent or metastatic breast cancer. Note: A participant maybe enrolled if she received prior (neo)adjuvant endocrine therapy (including,but not limited to anti-estrogens or aromatase inhibitors) for localizeddisease.
Are currently receiving or have previously received chemotherapy forlocoregionally recurrent or metastatic breast cancer. Note: Participants may beenrolled if they received prior (neo)adjuvant chemotherapy for localizeddisease.
Study Design
Connect with a study center
Universitair Ziekenhuis Antwerpen
Edegem, 2650
BelgiumSite Not Available
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven, 3000
BelgiumSite Not Available
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven 2792482, 3000
BelgiumSite Not Available
Centre Hospitalier Universitaire Sart Tilman
Liege, 4000
BelgiumSite Not Available
Centre Hospitalier Universitaire Sart Tilman
Liège 2792413, 4000
BelgiumSite Not Available
Centre Oscar Lambret
Lille 2998324, Hauts-de-France 11071624 59020
FranceSite Not Available
Hôpital Arnaud de Villeneuve - CHU Montpellier
Montpellier, Hérault 34090
FranceSite Not Available
Hôpital Arnaud de Villeneuve - CHU Montpellier
Montpellier 2992166, Hérault 34090
FranceSite Not Available
Centre Oscar Lambret
Lille, Nord-Pas-de-Calais 59020
FranceSite Not Available
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Lille, 59020
FranceSite Not Available
Centre Oscar Lambret
Lille Cedex, 59020
FranceSite Not Available
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Montpellier, 34295
FranceSite Not Available
CHU de Montpellier-Hopital Arnaud de Villeneuve
Montpellier Cedex 5, 34295
FranceSite Not Available
Hopital Larrey
Toulouse, 31059
FranceSite Not Available
Hopital Larrey
Toulouse 2972315, 31059
FranceSite Not Available
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Villejuif, 94805
FranceSite Not Available
Gustave Roussy
Villejuif Cedex, 94805
FranceSite Not Available
Istituto Scientifico Romagnolo - Studio e la Cura dei Tumori
Meldola, Forli 47014
ItalySite Not Available
Istituto Scientifico Romagnolo - Studio e la Cura dei Tumori
Meldola 3173635, Forli 47014
ItalySite Not Available
IRCCS Ospedale San Raffaele
Milan 6951411, 20132
ItalySite Not Available
IRCCS Ospedale San Raffaele
Milano, 20132
ItalySite Not Available
Hospital Nuestra Senora de Sonsoles
Avila, 05004
SpainSite Not Available
Nuestra Senora de Sonsoles
Avila, 05004
SpainSite Not Available
Hospital San Pedro de Alcantara
Caceres, 10003
SpainSite Not Available
Hospital San Pedro de Alcantara
Cáceres 2520611, 10003
SpainSite Not Available
Hospital Madrid Norte Sanchinarro
Madrid, 28050
SpainSite Not Available
Hospital Universitario 12 de Octubre
Madrid, 28041
SpainSite Not Available
Hospital Madrid Norte Sanchinarro
Madrid 3117735, 28050
SpainSite Not Available
Hospital Universitario 12 de Octubre
Madrid 3117735, 28041
SpainSite Not Available
Hospital Nuestra Senora de Sonsoles
Ávila 3129136, 05004
SpainSite Not Available
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Jhonghe City, 235
TaiwanSite Not Available
Tri-Service General Hospital
Neihu Taipei, 114
TaiwanSite Not Available
Taipei Medical University- Shuang Ho Hospital
New Taipei City, 235
TaiwanSite Not Available
Taipei Medical University- Shuang Ho Hospital
New Taipei City 12908892, 235
TaiwanSite Not Available
Chi Mei Hospital - Liouying Branch
Tainan, 73657
TaiwanSite Not Available
Chi-Mei Meical Center, Liouying
Tainan, 73657
TaiwanSite Not Available
Chi Mei Hospital - Liouying Branch
Tainan 1668355, 73657
TaiwanSite Not Available
National Taiwan University Hospital
Taipei, 10048
TaiwanSite Not Available
National Taiwan University Hospital
Taipei 1668341, 10048
TaiwanSite Not Available
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Antalya, 07059
TurkeySite Not Available
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Edirne, 22030
TurkeySite Not Available
Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi Yerleskesi
Istanbul, 34098
TurkeySite Not Available
Istanbul University Cerrahpasa Medical Faculty
Istanbul, 34098
TurkeySite Not Available
Ege Universitesi Hastanesi
Izmir, 35100
TurkeySite Not Available
Ege University Faculty of Medicine
Izmir, 35100
TurkeySite Not Available
Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi Yerleskesi
Istanbul 745044, 34098
Turkey (Türkiye)Site Not Available
Ege Universitesi Hastanesi
Izmir 311046, 35100
Turkey (Türkiye)Site Not Available
Highlands Oncology Group
Fayetteville, Arkansas 72703
United StatesSite Not Available
Highlands Oncology Group - Duplicate 2
Springdale, Arkansas 72762
United StatesSite Not Available
Highlands Oncology Group - Duplicate 2
Springdale 4132093, Arkansas 4099753 72762
United StatesSite Not Available
Univ of California San Francisco
San Francisco, California 94158
United StatesSite Not Available
Univ of California San Francisco
San Francisco 5391959, California 5332921 94158
United StatesSite Not Available
University of Colorado School of Medicine
Aurora, Colorado 80045
United StatesSite Not Available
University of Colorado School of Medicine
Aurora 5412347, Colorado 5417618 80045
United StatesSite Not Available
Dana Farber Cancer Institute
Boston, Massachusetts 02215
United StatesSite Not Available
Dana Farber Cancer Institute
Boston 4930956, Massachusetts 6254926 02215
United StatesSite Not Available
Karmanos Cancer Institute
Detroit, Michigan 48201
United StatesSite Not Available
Karmanos Cancer Institute
Farmington Hills, Michigan 48334
United StatesSite Not Available
Karmanos Cancer Institute
Detroit 4990729, Michigan 5001836 48201
United StatesSite Not Available
Karmanos Cancer Institute
Farmington Hills 4992523, Michigan 5001836 48334
United StatesSite Not Available
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United StatesSite Not Available
Memorial Sloan Kettering Cancer Center
New York 5128581, New York 5128638 10065
United StatesSite Not Available

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