Clinical trials: Abemaciclib
Breast Adenocarcinoma, Breast Cancer Stage IV
Predicting clinicAL outcoMes During First-line CDK4/6 Inhibitors Plus Endocrine Therapy in Patients With Advanced Hormone REceptor-poSitive HER2-negative Breast Cancer: the Retrospective-prospective Multicenter Italian PALMARES-2 Study
PALMARES-2 is a retrospective/prospective, observational, multicenter, population-based study, aiming at providing real-world evidences on HR+/HER2- aBC patients treated with first-line CDK4/6i plus ET.
- Conditions
- Breast Adenocarcinoma, Breast Cancer Stage IV, Breast Cancer, Metastatic, Breast Carcinoma
- Trial name
- PALMARES-2 (NCT06805812)
- Testing
- Palbociclib, Ribociclib, Abemaciclib
- Where
- 24 sites in Italy
- Volunteers
- 3,500 people
- Sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Breast Cancer
A PoC Study to Evaluate Treatments' Efficacy by Monitoring MRD Using ctDNA in HR-positive/HER2-negative EBC Population
This trial is a multicenter, open-label, non-comparative, phase II, biomarker-driven adjuvant treatment study involving the periodic collection and analysis of blood samples from patients with HR-positive/HER2-negative…
- Trial name
- MiRaDoR (NCT05708235)
- Testing
- Giredestrant, Abemaciclib, Inavolisib
- Where
- 41 sites in Spain, United Kingdom
- Volunteers
- 976 people
- Sponsor
- MedSIR
Breast Neoplasm, Neoplasm Metastasis
Abemaciclib (LY2835219) Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer
This study will evaluate the effect of adding abemaciclib to fulvestrant for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer that progressed or recurred…
- Trial name
- postMONARCH (NCT05169567)
- Testing
- Abemaciclib, Fulvestrant
- Where
- 138 sites in United States, Argentina and 15 more
- Volunteers
- 368 people
- Sponsor
- Eli Lilly and Company
Carcinoma, Non-small Cell Lung
A Study of Abemaciclib (LY2835219) in Combination With Another Anti-cancer Drug in Participants With Lung Cancer (NSCLC)
The main purpose of this study is to evaluate the safety and tolerability of abemaciclib in combination with another anti-cancer drug in participants with NSCLC that is advanced or has spread to other parts of the body (stage…
- Trial name
- NCT02079636
- Testing
- Abemaciclib, Pemetrexed, Gemcitabine
- Where
- 11 sites in United States, Spain
- Volunteers
- 142 people
- Sponsor
- Eli Lilly and Company
Metastatic Breast Cancer, ER-positive Breast Cancer
A Randomised Trial Comparing Trastuzumab Deruxtecan to CDK4/6 Inhibitors in Non-luminal A, ER-positive/HER2-low Metastatic Breast Cancer
The objective of this trial, DBCG R25, will be to evaluate the effect of trastuzumab-deruxtecan versus standard of care on progression-free survival (PFS) in first-line for patients with non-Luminal A, ER-positive/HER2-negative…
- Conditions
- Metastatic Breast Cancer, ER-positive Breast Cancer, Luminal B, Her2 Enriched
- Trial name
- DISCORDANT (NCT06585969)
- Testing
- Trastuzumab deruxtecan (T-DXd), Ribociclib with ET, Abemaciclib with ET
- Sponsor
- Danish Breast Cancer Cooperative Group
Breast Cancer
A Study of Abemaciclib (LY2835219) in Participants With Breast Cancer
The main purpose of this study is to evaluate the efficacy of the study drug abemaciclib in postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) locoregionally…
- Trial name
- MONARCH plus (NCT02763566)
- Testing
- Abemaciclib, Anastrozole, Letrozole
- Where
- 45 sites in Brazil, China and 2 more
- Volunteers
- 463 people
- Sponsor
- Eli Lilly and Company
Breast Cancer
Validation of Capillary Microsampling for Therapeutic Drug Monitoring of CDK4/6 Inhibitors in Breast Cancer Patients (TDHOME)
This is a prospective validation study, multicenter, open-label, single-arm study, evaluating the concordance between capillary microsampling (using the VAMS Mitra device) and venous sampling in patients undergoing CDK4/6 therapy.
- Trial name
- TDHOME (NCT07491380)
- Testing
- Capillary samples using the VAMS Mitra device
- Where
- 2 sites in France
- Volunteers
- 90 people
- Sponsor
- Institut Curie
Breast Cancer, HER2 + Breast Cancer
Pragmatic Study to Optimize Neoadjuvant Treatment and Surgical De-escalation in HR+/HER2- Early Breast Cancer Using Oncotype DX and Abemaciclib
This is a pragmatic phase 2 study to determine the proportion of patients with ER+ (≥10%)/HER2- EBC in whom neoadjuvant chemotherapy can be replaced by NET plus abemaciclib based on the results of the ODX RS obtained in the…
- Conditions
- Breast Cancer, HER2 + Breast Cancer, HR Positive, Neoadjuvant Therapy
- Trial name
- VIOLET (NCT07428018)
- Testing
- Abemaciclib
- Where
- Italy
- Volunteers
- 150 people
- Sponsor
- Mario Negri Institute for Pharmacological Research
Metastatic or Local Advanced Breast Cancer of Patients
A Trial of HRS-8080 Tablets in Metastatic or Local Advanced Breast Cancer of Adults
The study is being conducted to evaluate the tolerance, and safety of HRS-8080 tablets monotherapy and combined with other anti-cancer therapy for metastatic or local advanced breast cancer in adults.
- Trial name
- NCT05189717
- Testing
- HRS-8080 tablets、SHR 6390 tablets、Abemaciclib、Everolimus
- Where
- 2 sites in China
- Volunteers
- 156 people
- Sponsor
- Shandong Suncadia Medicine Co., Ltd.
Healthy
A Study of Abemaciclib (LY2835219) in Healthy Participants With and Without Food
The purpose of this study is to evaluate the amount of abemaciclib that reaches the blood stream and how long the body takes to get rid of it when given with and without food.
- Trial name
- NCT02482935
- Testing
- Abemaciclib
- Where
- 2 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Estrogen-receptor-positive Breast Cancer, HER2/Neu-Negative Breast Cancer
Elacestrant vs Elacestrant Plus a CDK4/6 Inhibitor in Patients With ERpositive/HER2-negative Advanced or Metastatic Breast Cancer
Breast cancer is not only the leading cause of cancer in women, but also the leading cause of cancer deaths in women. Estrogen receptor-positive and HER2-negative breast cancer is the most prevalent breast cancer subtype.
- Conditions
- Estrogen-receptor-positive Breast Cancer, HER2/Neu-Negative Breast Cancer, Advanced Breast Cancerv, Metastatic Breast Cancer
- Trial name
- NCT06062498
- Testing
- elacestrant, palbociclib, abemaciclib, ribociclib
- Where
- 3 sites in United States
- Volunteers
- 174 people
- Sponsor
- Northwestern University
PIK3CA Mutation, Solid Tumor, Adult
First-in-Human Study of RLY-5836 in Advanced Breast Cancer and Other Solid Tumors
This is a Phase 1, first-in-human, open-label study designed to evaluate the maximum tolerated dose (MTD), recommended phase 2 dose (RP2D), safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor…
- Conditions
- PIK3CA Mutation, Solid Tumor, Adult, HER2-negative Breast Cancer, Breast Cancer
- Trial name
- NCT05759949
- Testing
- RLY-5836, Fulvestrant, Palbociclib
- Where
- 7 sites in United States
- Volunteers
- 41 people
- Sponsor
- Relay Therapeutics, Inc.
Bladder Cancer
(CLONEVO): Cell cycLe inhbitiON to Target the EVolution of UrOthelial Cancer
Single-arm, open-label window-of-opportunity trial of neoadjuvant Abemaciclib in 20 patients, with tumor tissue obtained as standard of care at tumor resection (pre-Abemaciclib) and cystectomy (post-Abemaciclib)
- Trial name
- CLONEVO (NCT03837821)
- Testing
- Abemaciclib
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- Weill Medical College of Cornell University
Abemaciclib, Abemaciclib-related Diarrhea
Pharmacokinetic Model of Abemaciclib: Correlation With Severe Diarrhea as the Primary Toxicity Endpoint in Patients With Localized Hormone Receptor-positive Breast Cancer
Remarkable progress has recently been made in the treatment of locally advanced, hormone receptor-positive, HER2-negative breast cancer with a high risk of recurrence, thanks to the addition of abemaciclib to endocrine therapy.
- Conditions
- Abemaciclib, Abemaciclib-related Diarrhea, Breast Cancer
- Trial name
- DOSABEMA (NCT07490509)
- Testing
- Blood samples for PK, Questionnaire
- Volunteers
- 235 people
- Sponsor
- Poitiers University Hospital
Breast Cancer
Randomized Short-term Pre-surgical Study to Assess the Effects of Abemaciclib (LY2835219) in Early Breast Cancer Patients
Cyclins CDK4 / 6 are extensively involved in the proliferation and growth of numerous cancers including breast cancer. The objective of this study is to identify if a new preoperative oral treatment, abemaciclib directed against…
- Trial name
- ABC-POP (NCT02831530)
- Testing
- Abemaciclib
- Where
- France
- Volunteers
- 101 people
- Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
Recurrent Endometrial Carcinoma, Recurrent Fallopian Tube Carcinoma
Abemaciclib for the Treatment of Recurrent Ovarian or Endometrial Cancer
This phase II trial studies how well abemaciclib works in treating patients with ovarian or endometrial cancer that has an activation of the CDK4/6 pathway and that has come back (recurrent).
- Conditions
- Recurrent Endometrial Carcinoma, Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma
- Trial name
- NCT04469764
- Testing
- Abemaciclib, Anastrozole, Letrozole
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Jonsson Comprehensive Cancer Center
Glioma
Abemaciclib Neuropharmacokinetics of Diffuse Midline Glioma Using Intratumoral Microdialysis
Background: Diffuse midline gliomas are the most aggressive brain tumors of childhood and young adults. Most people with these tumors survive less than 2 years.
- Trial name
- NCT05413304
- Testing
- Pre-operative abemaciclib, Device for Cerebral Fluid Dialysate Collection, Ashion Analytics GEM ExTra
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- National Cancer Institute (NCI)
ctDNA Monitoring, Breast Cancer
Abemaciclib for Molecular Residual Disease Detected by Circulating Tumor DNA in HR+/HER2- Early Breast Cancer
The goal of this clinical study is to determine whether monitoring ctDNA and treating patients who become ctDNA-positive with abemaciclib can help prevent the recurrence of hormone receptor-positive, HER2-negative breast cancer…
- Trial name
- ARCHE (NCT07292207)
- Testing
- Abemaciclib 150 MG Oral Tablet
- Where
- Japan
- Volunteers
- 30 people
- Sponsor
- Nagoya City University
Metastatic Breast Cancer
Sequential Therapies Modeled on Evolutionary Dynamics for Breast Cancer
The purpose of the study is to test a treatment strategy with currently approved drugs to see if it is practical to administer the available drugs in a new way that researchers hope could be more effective in treating metastatic…
- Trial name
- NCT06409390
- Testing
- Taxotere, Cytoxan, Trastuzumab deruxtecan
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
Glioblastoma
Abemaciclib + Pembrolizumab In Glioblastoma
This research study is studying a combination therapy as a possible treatment for recurrent glioblastoma (GBM), a brain tumor that is growing or progressing despite earlier treatment.
- Trial name
- NCT04118036
- Testing
- Pembrolizumab, Abemaciclib
- Where
- 2 sites in United States
- Sponsor
- Dana-Farber Cancer Institute