Abemaciclib

Generic Name: Abemaciclib

Brand Names: Verzenio, Verzenios

Drug Type: Small Molecule

Chemical Formula: C_₂₇H_₃₂F_₂N_₈

CAS Number: 1231929-97-7

Unique Ingredient Identifier: 60UAB198HK

Background: Abemaciclib is an antitumor agent and dual inhibitor of cyclin-dependent kinases 4 (CDK4) and 6 (CDK6) that are involved in the cell cycle and promotion of cancer cell growth in case of unregulated activity. On September 28, 2017, FDA granted approval of abemaciclib treatment under the market name Verzenio for the treatment of HR-positive and HER2-negative advanced or metastatic breast cancer that has progressed after unsuccessful endocrine therapy. It is either given alone in patients who has undergone endocrine therapy and chemotherapy after the metastasis of cancer, or in combination with Fulvestrant. Following oral treatment in patients with HR-positive, HER2-negative breast cancer, abemaciclib demonstrated increased progression-free survival rates and objective response rates. Abemaciclib has been used in trials studying the treatment of melanoma, lymphoma, neoplasm, solid tumor, and glioblastoma.

Indication: 适应症为:⑴单药治疗接受过内分泌疗法和化疗后疾病进展的 ER+/HER2-晚期或转移性乳腺癌；⑵或联合氟维司群，二线治疗接受过内分泌疗法后疾病进展的 ER+/HER2-晚期或转移性乳腺癌；⑶联合芳香酶抑制剂作为 ER+/HER2-绝经后女性晚期或转移性乳腺癌的初始内分泌疗法。

Associated Conditions: HR+, HER2-, Advanced Breast Cancer, Early Hormone Receptor Positive, HER2/Neu Negative Node Positive Breast Cancer, Metastatic HR + HER2 - breast cancer

Clinical Trials

A Retrospective Real-world Study of Abemaciclib in HR+ Breast Cancer

Not yet recruiting

Conditions: Breast Cancer
Breast Diseases
Neoplasms

Interventions: Drug: Letrozole or Anastrozole
Drug: Abemaciclib and Fulvestrant
Drug: Fulvestrant
Drug: Abemaciclib and Letrozole/Anastrozole

First Posted Date: 2024-04-02

Last Posted Date: 2024-05-10

Lead Sponsor: The Affiliated Hospital of Qingdao University

Target Recruit Count: 200

Registration Number: NCT06341283

Locations: 🇨🇳
Clinical Research Center, Qingdao, Shandong, China

NEOadjuvant Abemaciclib and GIredestrant TriaL in Patients with ER-positive, HER2-negative Early Breast Cancer

Phase 2

Recruiting

Conditions: Breast Cancer

Interventions: Drug: Abemaciclib 150 MG + Giredestrant 30 MG

First Posted Date: 2024-02-14

Last Posted Date: 2025-02-18

Lead Sponsor: Fondazione Oncotech

Target Recruit Count: 51

Registration Number: NCT06259929

Locations: 🇮🇹
IRCCS Centro di Riferimento Oncologico (CRO), Aviano, PN, Italy
🇮🇹
Humanitas Istituto Clinico Catanese, Catania, Italy
🇮🇹
IRCCS Ospedale Policlinico San Martino, Genova, Italy

and more 5 locations

Discontinuation of CDK4/6 Inhibitors in Patients With Metastatic HR Positive, HER2 Negative Breast Cancer

Phase 2

Recruiting

Conditions: Breast Cancer

Interventions: Drug: Continuation of CDK4/6 inhibitor Palbociclib
Drug: Discontinuation of CDK4/6 inhibitor Palbociclib
Drug: Continuation of CDK4/6 inhibitor -Palbociclib
Drug: Discontinuation of CDK4/6 inhibitor -Palbociclib
Drug: Continuation of CDK4/6 inhibitor Abemaciclib
Drug: Discontinuation of CDK4/6 inhibitor Abemaciclib

First Posted Date: 2024-01-17

Last Posted Date: 2025-05-01

Lead Sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Target Recruit Count: 120

Registration Number: NCT06207734

Locations: 🇩🇪
MVZ für Hämatologie und Onkologie der MVZ Mülheim GmbH, Mülheim, Germany
🇩🇪
Onkologische GP Gütersloh, Gütersloh, Germany
🇩🇪
Hämatologisch-Onkologische Praxis Altona, Hamburg, Germany

and more 10 locations

A First-in-human Dose Escalation and Expansion Study to Evaluate the Safety, and Tolerability of AZD8421 Alone or in Combination in Participants With Selected Advanced or Metastatic Solid Tumors

Phase 1

Recruiting

Conditions: High-grade Serous Ovarian Cancer (HGSOC)
ER+ HER2- Advanced Breast Cancer

Interventions: Drug: AZD8421
Drug: Camizestrant
Drug: Abemaciclib
Drug: Ribociclib
Drug: Palbociclib

First Posted Date: 2024-01-03

Last Posted Date: 2025-05-18

Lead Sponsor: AstraZeneca

Target Recruit Count: 348

Registration Number: NCT06188520

Locations: 🇬🇧
Research Site, Manchester, United Kingdom

Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer

Phase 2

Recruiting

Conditions: Locally Advanced Unresectable HER2-Negative Breast Carcinoma
Metastatic HER2-Negative Breast Carcinoma
Anatomic Stage IV Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
Locally Advanced Unresectable Hormone Receptor-Positive Breast Carcinoma
Metastatic Hormone Receptor-Positive Breast Carcinoma

Interventions: Drug: Abemaciclib
Drug: Anastrozole
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Procedure: Diagnostic Imaging
Drug: Exemestane
Other: Fludeoxyglucose F-18
Drug: Fluorine F 18 Fluoro Furanyl Norprogesterone
Drug: Fulvestrant
Biological: Gonadotropin-releasing Hormone Analog
Drug: Letrozole
Procedure: Positron Emission Tomography
Drug: Tamoxifen
Drug: Therapeutic Estradiol

First Posted Date: 2023-12-21

Last Posted Date: 2025-03-12

Lead Sponsor: University of Washington

Target Recruit Count: 60

Registration Number: NCT06179303

Locations: 🇺🇸
Siteman Cancer Center at Washington University, Saint Louis, Missouri, United States
🇺🇸
Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States

Abemaciclib Dose Escalation to Maintain Intensity (ADE-MI)

Phase 4

Recruiting

Conditions: Breast Cancer

First Posted Date: 2023-12-13

Last Posted Date: 2025-03-27

Lead Sponsor: University of Illinois at Chicago

Target Recruit Count: 50

Registration Number: NCT06169371

Locations: 🇺🇸
Iowa Holden Comprehensive Cancer Center, Iowa City, Iowa, United States
🇺🇸
University of Illinois, Chicago, Illinois, United States

RADIANT: Pre-op Radiation With Abemaciclib and Letrozole

Phase 1

Recruiting

Conditions: Breast Cancer

Interventions: Drug: Abemaciclib
Drug: Letrozole

First Posted Date: 2023-11-18

Last Posted Date: 2024-04-03

Lead Sponsor: Mridula George, MD

Target Recruit Count: 15

Registration Number: NCT06139107

Locations: 🇺🇸
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States

A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)

Phase 3

Recruiting

Conditions: Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer

Interventions: Drug: Fulvestrant
Drug: Giredestrant
Drug: Abemaciclib
Drug: Palbociclib
Drug: Ribociclib
Drug: LHRH Agonist
Diagnostic Test: FoundationOne Liquid CDx Assay (F1LCDx)

First Posted Date: 2023-10-04

Last Posted Date: 2025-05-05

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 1050

Registration Number: NCT06065748

Locations: 🇨🇱
Clínica Puerto Montt, Puerto Montt, Chile
🇵🇪
Oncosalud Sac, Lima, Peru
🇩🇪
St. Elisabeth Krankenhaus Köln GmbH, Koeln, Germany

and more 319 locations

Evaluation of Abemaciclib and Radiation Therapy Before Surgery for the Treatment of High-Risk Adipocytic Retroperitoneal Sarcoma

Phase 1

Recruiting

Conditions: Retroperitoneal Sarcoma

Interventions: Drug: Abemaciclib
Procedure: Computed Tomography
Procedure: Magnetic Resonance Imaging
Radiation: Radiation Therapy
Procedure: Therapeutic Surgical Procedure

First Posted Date: 2023-09-06

Last Posted Date: 2025-03-25

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 18

Registration Number: NCT06025747

Locations: 🇺🇸
Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States

TRADE: Dose Escalation Tolerability of Abemaciclib in HR+ HER2- Early Stage Breast Cancer

Phase 2

Active, not recruiting

Conditions: Early-stage Breast Cancer
Breast Cancer
High Risk Breast Carcinoma

Interventions: Drug: Abemaciclib
Drug: Tamoxifen
Drug: Anastrozole
Drug: Letrozole
Drug: Exemestane
Drug: LHRH Agonist

First Posted Date: 2023-08-21

Last Posted Date: 2024-11-07

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 90

Registration Number: NCT06001762

Locations: 🇺🇸
Stamford Hospital, Stamford, Connecticut, United States
🇺🇸
Eastern Maine Medical Center (Northern Light), Brewer, Maine, United States
🇺🇸
New England Cancer Specialists, Scarborough, Maine, United States

and more 9 locations

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