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DRUG CLASS:

CDK4 inhibitor

5d
postMONARCH: Abemaciclib (LY2835219) Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer (clinicaltrials.gov)
P3, N=368, Active, not recruiting, Eli Lilly and Company | Trial completion date: Feb 2026 --> Dec 2027
Trial completion date
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 negative
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Verzenio (abemaciclib) • fulvestrant
7d
Abemaciclib in Treating Patients With Advanced, Refractory, and Unresectable Digestive System Neuroendocrine Tumors (clinicaltrials.gov)
P2, N=20, Active, not recruiting, University of Washington | Trial completion date: Sep 2027 --> Jul 2026 | Trial primary completion date: Sep 2026 --> Nov 2025
Trial completion date • Trial primary completion date
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Verzenio (abemaciclib)
7d
Safety and Efficacy of SPH4336 in Combination With Endocrine Therapy in the Treatment of Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov)
P2/3, N=254, Recruiting, Shanghai Pharmaceuticals Holding Co., Ltd | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2025 --> Dec 2026
Trial completion date • Trial primary completion date
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fulvestrant • SPH4336
8d
New P3 trial
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 positive • HR positive • HER-2 negative • HR positive + HER-2 negative
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Ibrance (palbociclib) • letrozole
9d
Enrollment closed • Real-world evidence
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HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PTEN (Phosphatase and tensin homolog) • AKT1 (V-akt murine thymoma viral oncogene homolog 1) • CDK4 (Cyclin-dependent kinase 4)
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HER-2 negative
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fulvestrant • Truqap (capivasertib)
9d
Enrollment open • First-in-human
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HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 negative
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giredestrant (RG6171) • omeprazole
15d
BREAKER: Breast Cancer RElapsed in Patients Treated With Adjuvant CDK4/6 Inhibitors: (clinicaltrials.gov)
P=N/A, N=750, Recruiting, European Institute of Oncology | Not yet recruiting --> Recruiting
Enrollment open • Real-world evidence
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 negative
19d
Ribociclib and Bicalutamide in AR+ TNBC (clinicaltrials.gov)
P1/2, N=37, Active, not recruiting, Kari Wisinski | Recruiting --> Active, not recruiting | Trial completion date: Sep 2025 --> Oct 2026 | Trial primary completion date: Sep 2025 --> Oct 2026
Enrollment closed • Trial completion date • Trial primary completion date
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • AR (Androgen receptor)
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HER-2 negative • AR positive • HER-2 negative + ER positive
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Kisqali (ribociclib) • bicalutamide
21d
Efficacy and Safety of Trastuzumab Rezetecan Followed by CDK4/6 Inhibitors and Endocrine Therapy in HR+/HER2-Low/Ultra-Low Advanced Breast Cancer (clinicaltrials.gov)
P2, N=45, Recruiting, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Not yet recruiting --> Recruiting
Enrollment open
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Herceptin (trastuzumab) • fulvestrant • trastuzumab rezetecan (SHR-A1811)
29d
SIGNAL-ER 101: Signatera-Guided CDK4/6 Inhibitor Therapy in Breast Cancer (clinicaltrials.gov)
P=N/A, N=725, Not yet recruiting, Natera, Inc. | Phase classification: P2 --> P=N/A | Initiation date: Nov 2025 --> Mar 2026
Phase classification • Trial initiation date
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Signatera™
1m
LEADER: CDK 4/6 Inhibitor, Ribociclib, With Adjuvant Endocrine Therapy for ER-positive Breast Cancer (clinicaltrials.gov)
P2, N=120, Active, not recruiting, Massachusetts General Hospital | Trial primary completion date: Oct 2025 --> Apr 2026
Trial primary completion date
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HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor)
|
HER-2 negative
|
Kisqali (ribociclib)
1m
Enrollment open
|
fulvestrant