^
13h
ELCIN: ELACESTRANT in Women and Men With CDK4/6 Inhibitor-Naive Estrogen Receptor Positive, HER-2 Negative Metastatic Breast Cancer Study (clinicaltrials.gov)
P2, N=80, Recruiting, Stemline Therapeutics, Inc. | Trial primary completion date: Feb 2024 --> Feb 2025
Trial primary completion date • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
|
Orserdu (elacestrant)
22h
Palbociclib inhibits the progression of head and neck cancer and improves the Cetuximab response under specific condition in vitro and in vivo. (PubMed, Mol Biol Rep)
In HPV-negative HNSCC, CDK4/6 inhibitor shows promising anti-tumor effects, which exhibits a synergistic effect when combined with EGFR inhibitor only in specific drug concentration and mouse model.
Preclinical • Journal
|
CCND1 (Cyclin D1) • MMP9 (Matrix metallopeptidase 9)
|
CCND1 overexpression
|
Erbitux (cetuximab) • cisplatin • Ibrance (palbociclib)
23h
Treatment outcomes in older patients with metastatic breast cancer receiving palbociclib plus an aromatase inhibitor: a plain language summary. (PubMed, Future Oncol)
Older patients who took palbociclib plus an aromatase inhibitor also lived longer without their cancer getting worse and started chemotherapy later than those who took an aromatase inhibitor alone. These results support using palbociclib plus an aromatase inhibitor as the first treatment for patients aged 75 years or older with HR+/HER2- metastatic breast cancer.
Review • Journal • Metastases
|
HER-2 (Human epidermal growth factor receptor 2)
|
HR positive • HER-2 negative • EGFR positive
|
Ibrance (palbociclib)
1d
Ribociclib (LEE011) in Preoperative Glioma and Meningioma Patients (clinicaltrials.gov)
P1, N=48, Active, not recruiting, Nader Sanai | Trial completion date: Jan 2024 --> Jan 2025
Trial completion date
|
CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • CCND1 (Cyclin D1) • CDK4 (Cyclin-dependent kinase 4) • CDKN2B (Cyclin Dependent Kinase Inhibitor 2B)
|
CDKN2A deletion • CCND1 amplification • CDK4 amplification
|
Kisqali (ribociclib)
1d
EUCHARIS: European Treatment Patterns and Outcomes Associated With First-Line CDK4/6 Inhibition and Hormonal Therapies (clinicaltrials.gov)
P=N/A, N=1939, Completed, Pfizer | Recruiting --> Completed | Trial completion date: Mar 2024 --> Nov 2023 | Trial primary completion date: Mar 2024 --> Nov 2023
Trial completion • Trial completion date • Trial primary completion date • Real-world evidence • Real-world
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 negative
|
Ibrance (palbociclib)
1d
ImmunoADAPT: Neoadjuvant Endocrine Therapy, Palbociclib, Avelumab in Estrogen Receptor Positive Breast Cancer (clinicaltrials.gov)
P2, N=33, Active, not recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Dec 2023 --> Dec 2025 | Trial primary completion date: Dec 2023 --> Jul 2024
Trial completion date • Trial primary completion date
|
ER (Estrogen receptor)
|
ER positive
|
Ibrance (palbociclib) • tamoxifen • Bavencio (avelumab) • Eligard (leuprolide acetate) • goserelin acetate
1d
Enrollment closed • Combination therapy • Metastases
|
Ibrance (palbociclib)
1d
LY3214996 Plus Abemaciclib in Recurrent Glioblastoma Patients (clinicaltrials.gov)
P1, N=50, Recruiting, Nader Sanai | Trial completion date: Feb 2024 --> Feb 2025 | Trial primary completion date: Dec 2023 --> Dec 2024
Trial completion date • Trial primary completion date • Combination therapy
|
CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • CDK4 (Cyclin-dependent kinase 4) • CDKN2B (Cyclin Dependent Kinase Inhibitor 2B)
|
CDK4 amplification
|
Verzenio (abemaciclib) • temuterkib (LY3214996)
2d
Cyclin dependent kinase 4/6 inhibitor palbociclib synergizes with BCL2 inhibitor venetoclax in experimental models of mantle cell lymphoma without RB1 deletion. (PubMed, Exp Hematol Oncol)
Our data strongly support investigation of the chemotherapy-free palbociclib and venetoclax combination as an innovative treatment strategy for post-ibrutinib MCL patients without RB1 deletion.
Journal • IO biomarker
|
MYC (V-myc avian myelocytomatosis viral oncogene homolog) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • RB1 (RB Transcriptional Corepressor 1) • MCL1 (Myeloid cell leukemia 1) • BCL2L1 (BCL2-like 1)
|
CDKN2A deletion • RB1 deletion • MYC expression • CDK4 overexpression • CDKN2A overexpression • RB deletion
|
Venclexta (venetoclax) • Ibrance (palbociclib) • Imbruvica (ibrutinib)
3d
Ribociclib and Bicalutamide in AR+ TNBC (clinicaltrials.gov)
P1/2, N=37, Recruiting, Kari Wisinski | Trial primary completion date: Jan 2024 --> May 2024
Trial primary completion date • Combination therapy • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • AR (Androgen receptor)
|
HER-2 negative • AR positive
|
Kisqali (ribociclib) • bicalutamide
3d
TRADE: Dose Escalation Tolerability of Abemaciclib in HR+ HER2- Early Stage Breast Cancer (clinicaltrials.gov)
P2, N=90, Recruiting, Dana-Farber Cancer Institute | Initiation date: Feb 2024 --> Oct 2023
Trial initiation date
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 negative
|
tamoxifen • Verzenio (abemaciclib) • letrozole • anastrozole • exemestane
3d
The effects of low HER2 expression on survival in patients with metastatic breast cancer treated with CDK 4/6 inhibitors: a multicenter retrospective study. (PubMed, Breast Cancer Res Treat)
The prognostic value of HER2-low status remains controversial. Our study showed no significant effect of HER2 low expression on survival in patients receiving CDK 4/6i plus ET.
Retrospective data • Journal • Metastases
|
HER-2 (Human epidermal growth factor receptor 2)
|
HR positive • HER-2 negative • HER-2 expression • HER-2 underexpression • PTEN mutation + HR positive
|
Ibrance (palbociclib) • Kisqali (ribociclib)
3d
A Study of LY2835219 (Abemaciclib) in Combination With Therapies for Breast Cancer That Has Spread (clinicaltrials.gov)
P1, N=198, Active, not recruiting, Eli Lilly and Company | Phase classification: P1b --> P1
Phase classification • Combination therapy • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • CDK4 (Cyclin-dependent kinase 4) • CDK6 (Cyclin-dependent kinase 6)
|
HR positive • HER-2 negative • EGFR positive
|
Herceptin (trastuzumab) • everolimus • tamoxifen • Perjeta (pertuzumab) • Verzenio (abemaciclib) • fulvestrant • letrozole • anastrozole • exemestane • samotolisib (LY3023414)
3d
KEYNOTE 287: A Study of Abemaciclib (LY2835219) in Participants With Non-Small Cell Lung Cancer or Breast Cancer (clinicaltrials.gov)
P1, N=100, Active, not recruiting, Eli Lilly and Company | Phase classification: P1b --> P1
Phase classification • Combination therapy • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase)
|
KRAS mutation
|
Keytruda (pembrolizumab) • Verzenio (abemaciclib) • anastrozole
4d
Ribociclib plus Endocrine Therapy in Early Breast Cancer. (PubMed, N Engl J Med)
Ribociclib plus an NSAI significantly improved invasive disease-free survival among patients with HR-positive, HER2-negative stage II or III early breast cancer. (Funded by Novartis; NATALEE ClinicalTrials.gov number, NCT03701334.).
Journal
|
HER-2 (Human epidermal growth factor receptor 2)
|
HR positive • HER-2 negative • EGFR positive • PTEN mutation + HR positive
|
Kisqali (ribociclib) • letrozole • anastrozole • goserelin acetate
4d
Exemestane plus everolimus and palbociclib in metastatic breast cancer: clinical response and genomic/transcriptomic determinants of resistance in a phase I/II trial. (PubMed, Nat Commun)
Multi-omics data from the phase IIa patients (n = 24 tumor/17 blood biopsy exomes; n = 27 tumor transcriptomes) showed potential mechanisms of resistance (convergent evolution of HER2 activation, BRAFV600E), identified joint genomic/transcriptomic resistance features (ESR1 mutations, high estrogen receptor pathway activity, and a Luminal A/B subtype; ERBB2/BRAF mutations, high RTK/MAPK pathway activity, and a HER2-E subtype), and provided hypothesis-generating results suggesting that mTOR pathway activation correlates with response to the trial's therapy. Our results illustrate how genome and transcriptome sequencing may help better identify patients likely to respond to CDK4/6i therapies.
P1/2 data • Clinical Trial,Phase I • Clinical Trial,Phase II • Journal • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • BRAF (B-raf proto-oncogene) • ER (Estrogen receptor)
|
BRAF V600E • BRAF V600 • HER-2 mutation • ER mutation • ESR1 mutation
|
Ibrance (palbociclib) • everolimus • exemestane
5d
Elderly patients with hormone receptor-positive HER2-negative metastatic breast cancer treated with CDK4/6 inhibitors in a multicentre cohort. (PubMed, Clin Transl Oncol)
Our RWD suggests that elderly patients, when compared to those under 70, experience similar survival outcomes and exhibit comparable tolerance for CDK4/6i therapy.
Journal • Metastases
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 positive • HR positive • HER-2 negative • HR positive + HER-2 negative • PTEN mutation + HR positive
6d
A rare case of Takotsubo cardiomyopathy. (PubMed, Eur Rev Med Pharmacol Sci)
Pharmacovigilance and experimental studies are warranted to confirm any causative relationship and to explore the underlying pathophysiology, respectively.
Clinical • Journal
|
HER-2 (Human epidermal growth factor receptor 2)
|
HR positive • HER-2 negative • EGFR positive • HR positive + HER-2 negative
|
Ibrance (palbociclib) • letrozole
6d
Prolonging the lives of African-Americans with metastatic breast cancer by adding palbociclib to an aromatase inhibitor in routine clinical practice: a plain language summary of a real-world database study. (PubMed, Future Oncol)
These results support the use of palbociclib with an AI as a first treatment for African-Americans with HR+/HER2- MBC. Clinical Trial Registration: NCT05361655 (ClinicalTrials.gov).
Review • Journal • Real-world evidence • Real-world • Metastases
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 negative
|
Ibrance (palbociclib)
6d
Evaluating a targeted Palbociclib-Trastuzumab loaded smart niosome platform for treating HER2 positive breast cancer cells. (PubMed, Int J Pharm X)
Fluorescence imaging further validated the internalization of particles into cells. In conclusion, Trz-Pal-pHSNs emerge as a promising platform for personalized medicine in the treatment of HER2-positive breast cancer.
Journal
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 positive • HER-2 overexpression
|
Herceptin (trastuzumab) • Ibrance (palbociclib)
6d
PATHWAY: PAlbociclib Plus Tamoxifen for the Treatment of Hormone Receptor-positive, HER2-negative Advanced Breast Cancer Women - Asian studY (clinicaltrials.gov)
P3, N=180, Active, not recruiting, National Cancer Center, Japan | Trial completion date: Apr 2025 --> Sep 2025 | Trial primary completion date: Apr 2025 --> Sep 2025
Trial completion date • Trial primary completion date • Metastases
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 negative
|
Ibrance (palbociclib) • tamoxifen • goserelin acetate
6d
PRESERVE3: Trilaciclib, a CDK 4/6 Inhibitor, in Patients With Advanced/Metastatic Bladder Cancer Receiving Chemotherapy Then Avelumab (clinicaltrials.gov)
P2, N=92, Terminated, G1 Therapeutics, Inc. | Active, not recruiting --> Terminated; Sponsor no longer pursuing trila for the indication.
Trial termination • Metastases
|
cisplatin • carboplatin • gemcitabine • Bavencio (avelumab) • Cosela (trilaciclib)
6d
Journal • CAR T-Cell Therapy
|
KMT2A (Lysine Methyltransferase 2A)
|
MLL rearrangement
|
Ibrance (palbociclib) • Blincyto (blinatumomab)
6d
Trilaciclib in Patients Receiving Sacituzumab Govitecan-hziy for Triple Negative Breast Cancer (clinicaltrials.gov)
P2, N=30, Active, not recruiting, G1 Therapeutics, Inc. | Trial primary completion date: Jun 2023 --> Nov 2023
Trial primary completion date • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset)
|
BRCA2 mutation • BRCA1 mutation • HER-2 negative • ER negative • PGR negative
|
Trodelvy (sacituzumab govitecan-hziy) • Cosela (trilaciclib)
7d
Abemaciclib for Bone and Soft Tissue Sarcoma With Cyclin-Dependent Kinase (CDK) Pathway Alteration (clinicaltrials.gov)
P2, N=44, Recruiting, Medical College of Wisconsin | Trial completion date: Sep 2025 --> Jun 2027 | Trial primary completion date: Sep 2024 --> Jun 2026
Trial completion date • Trial primary completion date • Metastases
|
Verzenio (abemaciclib)
7d
PACE: A Randomized Phase II Study of Fulvestrant, Palbociclib, and Avelumab After Progression on Cyclin-Dependent Kinase 4/6 Inhibitor and Aromatase Inhibitor for Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor-Negative Metastatic Breast Cancer. (PubMed, J Clin Oncol)
The addition of palbociclib to fulvestrant did not improve PFS versus fulvestrant alone among patients with hormone receptor-positive/HER2- MBC whose disease had progressed on a previous CDK4/6i plus AI. The increased PFS seen with the addition of avelumab warrants further investigation in this patient population.
P2 data • Journal • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
|
HER-2 positive • HR positive • HER-2 negative • EGFR positive • EGFR negative
|
Ibrance (palbociclib) • Bavencio (avelumab) • fulvestrant
7d
ValerEE: A Prospective NIS to Evaluate the Clinical Outcomes of Risarg® (Ribociclib) Combined With Endocrine Therapy or Chemotherapy in Patients With HR+HER2 - aBC in Routine Clinical Practice in the Russia (clinicaltrials.gov)
P=N/A, N=376, Recruiting, Novartis Pharmaceuticals | Not yet recruiting --> Recruiting | Trial completion date: Jun 2025 --> Jun 2027 | Trial primary completion date: Jun 2025 --> Jun 2027
Enrollment open • Trial completion date • Trial primary completion date • Metastases
|
Kisqali (ribociclib)
7d
A Signal-finding Study of Abemaciclib in Heavily Pretreated Patients with Metastatic Castration-Resistant Prostate Cancer: Results from CYCLONE 1. (PubMed, Clin Cancer Res)
Abemaciclib monotherapy was well tolerated and showed clinical activity in this heavily pretreated population, nearly half with visceral metastases. This study is considered preliminary proof-of-concept and designates CDK4/6 as a valid therapeutic target in prostate cancer.
Journal • Metastases
|
ER (Estrogen receptor)
|
Verzenio (abemaciclib)
7d
Trial primary completion date • Liquid biopsy • Metastases • Biopsy
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
|
ER positive • HER-2 negative
|
Ibrance (palbociclib) • letrozole • anastrozole
8d
The CDK4/6 inhibitor Palbociclib synergizes with ATRA to induce differentiation in AML. (PubMed, Mol Cancer Ther)
These enhanced differentiation effects may be associated with the regulation of transcription factors, including RARα, E2F1, and STAT1. Overall, our findings demonstrate that CDK4/6 inhibition sensitizes AML cells to ATRA and could guide the development of novel therapeutic strategies for AML patients.
Journal
|
RARA (Retinoic Acid Receptor Alpha) • STAT1 (Signal Transducer And Activator Of Transcription 1) • E2F1 (E2F transcription factor 1)
|
Ibrance (palbociclib)
8d
Significance of Aneuploidy in Predicting Prognosis and Treatment Response of Uveal Melanoma. (PubMed, Curr Med Chem)
UM in this study was divided into three CNV subtypes, and a model based on eight aneuploidy score-related genes was established to evaluate the prognosis and drug treatment efficacy of UM patients. The current results may have the potential to help the clinical decision-making process for UM management.
Journal • IO biomarker
|
NQO1 (NAD(P)H dehydrogenase, quinone 1) • FKBP10 (FKBP Prolyl Isomerase 10)
|
Ibrance (palbociclib) • Koselugo (selumetinib) • Kisqali (ribociclib)
10d
Targeted Therapy With CDK4/6 Inhibitors in Chemo-Refractory, Rb Wild-Type Extensive SCLC (clinicaltrials.gov)
P2, N=29, Recruiting, Case Comprehensive Cancer Center | Trial completion date: Jun 2024 --> Jun 2025 | Trial primary completion date: Jun 2024 --> Jun 2025
Trial completion date • Trial primary completion date
|
Verzenio (abemaciclib)
10d
Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer (clinicaltrials.gov)
P2, N=60, Not yet recruiting, University of Washington | Trial completion date: Mar 2025 --> Jun 2026
Trial completion date • Metastases
|
tamoxifen • Verzenio (abemaciclib) • fulvestrant • letrozole • anastrozole • exemestane
10d
PALBOCICLIB + PD-0325901 for NSCLC & Solid Tumors (clinicaltrials.gov)
P1, N=60, Completed, Dana-Farber Cancer Institute | Active, not recruiting --> Completed | Phase classification: P1/2 --> P1 | N=139 --> 60
Trial completion • Phase classification • Enrollment change • Combination therapy
|
KRAS (KRAS proto-oncogene GTPase) • RAS (Rat Sarcoma Virus)
|
KRAS mutation • RAS mutation
|
Ibrance (palbociclib) • mirdametinib (PD-0325901)
10d
monarcHER: A Study of Abemaciclib (LY2835219) in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov)
P2, N=237, Completed, Eli Lilly and Company | Active, not recruiting --> Completed | Trial completion date: Dec 2024 --> Nov 2023
Trial completion • Trial completion date • Metastases
|
Herceptin (trastuzumab) • Verzenio (abemaciclib) • fulvestrant
10d
Efficacy of first-line CDK 4-6 inhibitors in premenopausal patients with metastatic breast cancer and the effect of dose reduction due to treatment-related neutropenia on efficacy: a Turkish Oncology Group (TOG) study. (PubMed, J Chemother)
In our study, we aimed to evaluate the effectiveness of palbociclib and ribociclib in first-line treatment in patients with premenopausal metastatic breast cancer and the effect of dose reduction due to neutropenia on progression-free survival...Liver metastasis, using a fulvestrant together with a CDK 4-6 inhibitor, ECOG PS 1 was found to be a negative prognostic factor...In our study, we found PFS over 27 months in patients diagnosed with premenopausal breast cancer with CDK 4-6 inhibitors used in first-line treatment, similar to post-menopausal patients. We did not detect any difference between the effectiveness of the two CDK 4-6 inhibitors, and we showed that there was no decrease in the effectiveness of the CDK 4-6 inhibitor in patients whose dose was reduced due to neutropenia.
Journal • Metastases
|
HER-2 (Human epidermal growth factor receptor 2)
|
HR positive • HER-2 negative • PTEN mutation + HR positive
|
Ibrance (palbociclib) • Kisqali (ribociclib) • fulvestrant
10d
PRMT5 is an actionable therapeutic target in CDK4/6 inhibitor-resistant ER+/RB-deficient breast cancer. (PubMed, Nat Commun)
Furthermore, treatment with the PRMT5 inhibitor pemrametostat and a selective ER degrader fulvestrant synergistically inhibits growth of ER+/RB-deficient cell-derived and patient-derived xenografts. These findings highlight dual ER and PRMT5 blockade as a potential therapeutic strategy to overcome resistance to CDK4/6i in ER+/RB-deficient breast cancer.
Journal
|
ER (Estrogen receptor) • RB1 (RB Transcriptional Corepressor 1) • FUS (FUS RNA Binding Protein)
|
ER positive
|
fulvestrant • pemrametostat (GSK3326595)
11d
Study of Palbociclib in Combination With Binimetinib for Patients With Advanced KRAS Mutant Non-Small Cell Lung Cancer (clinicaltrials.gov)
P1, N=34, Active, not recruiting, Dana-Farber Cancer Institute | Recruiting --> Active, not recruiting | Phase classification: P1/2 --> P1 | N=72 --> 34 | Trial completion date: Mar 2024 --> Jun 2025
Enrollment closed • Phase classification • Enrollment change • Trial completion date • Combination therapy • Metastases
|
KRAS (KRAS proto-oncogene GTPase)
|
KRAS mutation
|
Ibrance (palbociclib) • Mektovi (binimetinib)
13d
New trial • Combination therapy • Real-world evidence • Real-world effectiveness • Real-world • Metastases
|
Kisqali (ribociclib) • fulvestrant • exemestane
13d
Palbociclib With Cetuximab and IMRT for Locally Advanced Squamous Cell Carcinoma (clinicaltrials.gov)
P1/2, N=27, Active, not recruiting, Mahidol University | Trial primary completion date: Sep 2022 --> Mar 2024
Trial primary completion date • Combination therapy • Metastases
|
Erbitux (cetuximab) • Ibrance (palbociclib)
13d
MiMe-A: Multiorgan Metabolic Imaging Response Assessment of Abemaciclib (clinicaltrials.gov)
P2, N=85, Completed, Jules Bordet Institute | Active, not recruiting --> Completed
Trial completion • Pan tumor
|
Verzenio (abemaciclib)
13d
Enzalutamide With and Without Ribociclib for Metastatic, Castrate-Resistant, Chemotherapy-Naive Prostate Cancer That Retains RB Expression (clinicaltrials.gov)
P1/2, N=46, Completed, Sidney Kimmel Cancer Center at Thomas Jefferson University | Active, not recruiting --> Completed | Trial completion date: Dec 2023 --> Sep 2023
Trial completion • Trial completion date • Metastases
|
enzalutamide capsule • Kisqali (ribociclib)