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1d
PROTECT-2: Trilaciclib in Patients Receiving Sacituzumab Tirumotecan for EGFR-mutated, Advanced Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
P2, N=49, Recruiting, The First Affiliated Hospital of Xiamen University | Not yet recruiting --> Recruiting | Trial completion date: May 2027 --> Dec 2027 | Initiation date: Jun 2025 --> Dec 2025 | Trial primary completion date: Jun 2026 --> Mar 2027
Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date
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EGFR mutation
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Cosela (trilaciclib) • Jiataile (sacituzumab tirumotecan)
1d
FAIM: Fulvestrant, Ipatasertib and CDK4/6 Inhibition in Metastatic ER+/HER2- Breast Cancer Patients Without ctDNA Suppression (clinicaltrials.gov)
P2, N=57, Active, not recruiting, Royal Marsden NHS Foundation Trust | Recruiting --> Active, not recruiting | N=324 --> 57 | Trial completion date: Sep 2026 --> Jun 2027 | Trial primary completion date: Sep 2026 --> Jun 2027
Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date • Circulating tumor DNA
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
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HER-2 positive • ER positive • HER-2 negative • ER positive + HER-2 negative • HER-2 negative + ER positive
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Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • fulvestrant • ipatasertib (RG7440) • Pegasys (pegylated interferon α -2a)
1d
Ribociclib in Hormone Receptor-positive, HER2-negative Early Breast Cancer With Residual Disease After Neoadjuvant Chemotherapy (clinicaltrials.gov)
P3, N=446, Recruiting, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Not yet recruiting --> Recruiting
Enrollment open
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
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HR positive • HER-2 negative • PGR positive
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MammaPrint®
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Kisqali (ribociclib)
2d
Ribociclib for HR-positive HER2-negative Metastatic Breast Cancer (clinicaltrials.gov)
P1/2, N=86, Recruiting, Nagoya City University | Not yet recruiting --> Recruiting
Enrollment open
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
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ER positive • HR positive • HER-2 negative • PGR positive • HER-2 negative + AR positive + ER positive • HER-2 negative + ER positive
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Kisqali (ribociclib) • anastrozole
2d
CAMPFIRE: A Study of Abemaciclib (LY2835219) in Participants With Ewing's Sarcoma (clinicaltrials.gov)
P2, N=46, Active, not recruiting, Eli Lilly and Company | Trial completion date: Sep 2028 --> Dec 2026
Trial completion date
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temozolomide • Verzenio (abemaciclib) • irinotecan
2d
EVOLVE-BDT: Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies (clinicaltrials.gov)
P2, N=700, Recruiting, UNC Lineberger Comprehensive Cancer Center | Not yet recruiting --> Recruiting
Enrollment open
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everolimus • capecitabine • Verzenio (abemaciclib)
2d
Testing the Addition of an Anti-Cancer Drug, Abemaciclib, to the Usual Chemotherapy Treatment (5-Fluorouracil) for Metastatic, Refractory Colorectal Cancer (clinicaltrials.gov)
P1, N=39, Recruiting, National Cancer Institute (NCI) | Trial completion date: Apr 2026 --> Apr 2027 | Trial primary completion date: Apr 2026 --> Apr 2027
Trial completion date • Trial primary completion date
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RAS wild-type
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Verzenio (abemaciclib) • fluorouracil topical
2d
PERFORM: First-line Palbociclib and Endocrine Therapy for Patients With HR+/HER2- Advanced Breast Cancer in the Real-world Setting. (clinicaltrials.gov)
P=N/A, N=1407, Active, not recruiting, Pfizer | Trial completion date: Apr 2029 --> Apr 2028 | Trial primary completion date: Apr 2029 --> Apr 2028
Trial completion date • Trial primary completion date • HEOR • Real-world evidence
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 negative
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Ibrance (palbociclib) • fulvestrant • exemestane
3d
Abemaciclib in Combination With Bicalutamide for Androgen Receptor-positive, HER2-negative Metastatic Breast Cancer (clinicaltrials.gov)
P1/2, N=42, Recruiting, Icahn School of Medicine at Mount Sinai | Trial completion date: Dec 2027 --> Jun 2028 | Trial primary completion date: Dec 2026 --> Jun 2027
Trial completion date • Trial primary completion date
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HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor)
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HER-2 negative
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Verzenio (abemaciclib) • bicalutamide
3d
Neoadjuvant palbociclib and endocrine therapy versus chemotherapy in ER + /HER2- breast cancer: a randomized phase II trial. (PubMed, Nat Commun)
In PREDIX LumB patients with estrogen receptor positive and human epidermal growth factor receptor negative (ER + /HER2-) breast cancer > 20 mm and/or with lymph node metastasis were randomized 1:1 to receive either paclitaxel weekly for 12 weeks followed by palbociclib and endocrine therapy for 12 weeks (arm A), or the reverse sequence (arm B). The predictive signature was independently validated in the CORALLEEN trial (pinteraction=0.048). Clinicaltrials.gov identifier: NCT02603679.
P2 data • Journal
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
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ER positive • HER-2 negative • EGFR negative
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Ibrance (palbociclib) • paclitaxel
6d
POLAR: Palbociclib for HR Positive / HER2-negative Isolated Locoregional Recurrence of Breast Cancer (clinicaltrials.gov)
P3, N=405, Active, not recruiting, ETOP IBCSG Partners Foundation | Trial primary completion date: Jan 2026 --> Jul 2026
Trial primary completion date
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
|
HR positive • HER-2 negative
|
Ibrance (palbociclib) • tamoxifen • fulvestrant • exemestane
6d
Phase II Palbociclib +Ibrutinib in Mantle Cell Lymphoma (clinicaltrials.gov)
P2, N=39, Active, not recruiting, Alliance Foundation Trials, LLC. | Trial completion date: Mar 2026 --> Aug 2026 | Trial primary completion date: Mar 2026 --> Nov 2025
Trial completion date • Trial primary completion date
|
CCND1 (Cyclin D1) • CD4 (CD4 Molecule) • CD5 (CD5 Molecule)
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Chr t(11;14)
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Ibrance (palbociclib) • Imbruvica (ibrutinib)