Clinical trials: Abemaciclib, open to volunteers
Low Grade Serous Ovarian Carcinoma, Adult Type Granulosa Cell Tumor
Abemaciclib and Letrozole in Patients With Estrogen Receptor-positive Rare Ovarian Cancer
The purpose of this study is to assess the efficacy and safety of abemaciclib and letrozole for treatment of estrogen receptor-positive rare ovarian cancer.
- Trial name
- ALEPRO (NCT05872204)
- Testing
- Abemaciclib, Letrozole
- Where
- 12 sites in Belgium, France and 1 more
- Volunteers
- 100 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Breast Neoplasms, Neoplasm Metastasis
A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA)
The purpose of the study is to assess the efficacy and safety of the addition of Tersolisib (LY4064809/STX-478) to other anti-cancer drugs as first treatment for advanced hormone receptor-positive (HR+)/human epidermal growth…
- Trial name
- NCT07174336
- Testing
- LY4064809, Ribociclib, Palbociclib
- Where
- 364 sites in United States, Argentina and 17 more
- Volunteers
- 800 people
- Sponsor
- Eli Lilly and Company
Castration-Resistant Prostate Carcinoma, Metastatic Prostate Adenocarcinoma
Abemaciclib Before 177Lu-PSMA-617 for the Treatment of Metastatic Castrate Resistant Prostate Cancer
This phase I/II trial tests the safety, side effects, and best dose of abemaciclib and whether it works before 177Lu-PSMA-617 in treating patients with castration resistant prostate cancer that has spread to other places in the…
- Conditions
- Castration-Resistant Prostate Carcinoma, Metastatic Prostate Adenocarcinoma, Stage IV Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8
- Trial name
- UPLIFT (NCT05113537)
- Testing
- Abemaciclib, Lutetium Lu 177-PSMA-617
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Vadim S Koshkin
Breast Cancer
Abemaciclib Dose Escalation to Maintain Intensity (ADE-MI)
This is a post-marketing single arm, phase IV trial in which patients with high-risk early-stage HR+HER2- breast cancer will receive adjuvant abemaciclib in combination with endocrine therapy (ET) After study intervention…
- Trial name
- BRE-09 (NCT06169371)
- Testing
- Abemaciclib
- Where
- 3 sites in United States
- Volunteers
- 100 people
- Sponsor
- University of Illinois Chicago
Advanced Breast Cancer
Genetically-informed Therapy for ER+ Breast Cancer Post-CDK4/6 Inhibitor
The purpose of this study is to learn if certain drug combinations are effective treatments for patients with advanced ER+/HER2- who have previously been treated with palbociclib, ribociclib, or abemaciclib.
- Trial name
- GERTRUDE (NCT05933395)
- Testing
- Fulvestrant, Neratinib, Alpelisib
- Where
- United States
- Volunteers
- 135 people
- Sponsor
- Dartmouth-Hitchcock Medical Center
Breast Cancer, Metastatic Breast Cancer
Anastrazole, Fulvestrant & Abemaciclib for HR+HER2- Metastatic Breast Cancer
This is a phase 2, open-label, singled-arm clinical trial determining efficacy of combination therapy with anastrozole, fulvestrant and abemaciclib in subjects with breast cancer.
- Conditions
- Breast Cancer, Metastatic Breast Cancer, Hormone Receptor-positive Breast Cancer, HER2-negative Breast Cancer
- Trial name
- NCT05524584
- Testing
- Fulvestrant, Anastrozole, Abemaciclib
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of California, Irvine
Early-stage Breast Cancer
Adopting the MRD Strategy to Optimize Post-operation Adjuvant Therapies for Early Stage Breast Cancer
This study is a prospective, multi-center, open-label cohort study, with 3 years disease free survival(DFS) as the primary endpoint.
- Trial name
- AMENDER (NCT05345860)
- Testing
- The MRD strategy for high risk or MRD+ TNBC patients, The MRD strategy for high risk or MRD+ HER2+ patients, The MRD strategy for high risk or MRD+ ER+ patients
- Where
- 3 sites in China
- Volunteers
- 300 people
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Retroperitoneal Sarcoma, Liposarcoma
A Phase 1 Study of Neoadjuvant Abemaciclib in Combination With Radiation Therapy for Liposarcomas
This phase I trial tests the safety, side effects, and best dose of abemaciclib and how well it works with radiation therapy before surgery in treating patients with high-risk adipocytic retroperitoneal sarcoma.
- Conditions
- Retroperitoneal Sarcoma, Liposarcoma, Dedifferentiated Liposarcoma
- Trial name
- NCT06025747
- Testing
- Abemaciclib, Computed Tomography, Magnetic Resonance Imaging
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- University of Washington
Breast Cancer
Study to Understand Relationship Between Gut Health and Toxicities of Hormonal Breast Cancer Treatment
This study will be conducted in 2 sequential parts. The first part will be a prospective, observational study. This will be followed by a small interventional, pilot study involving use of fiber supplement (chia seeds).
- Trial name
- GEMMA (NCT07553234)
- Testing
- Stool Sampling, Chia Seeds
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Chicago
HR+/HER2- Early Breast Cancer
Patient Relevant Outcomes Improvement Program in High Risk Hormone Receptor Positive (HR+) Breast Cancer
The goal of this observational study is to evaluate how persistently patients with high-risk early breast cancer take abemaciclib 6 months after therapy start.
- Trial name
- PROSPER (NCT07531693)
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- Institut fuer Frauengesundheit
Breast Neoplasms
A Non-interventional Study for Kisqali (Ribociclib) in Combination With an Aromatase Inhibitor for Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer at High Risk of Recurrence
This non-interventional observational study evaluates the real-world effectiveness and safety profile of ribociclib in combination with an aromatase inhibitor for adjuvant treatment in patients with HR+/HER2- early breast cancer…
- Trial name
- CAROLEEN (NCT06830720)
- Testing
- ribociclib + AI ± LHRH, abemaciclib + ET ± LHRH, ET mono ± LHRH
- Where
- 287 sites in Austria, Germany
- Volunteers
- 3,250 people
- Sponsor
- Novartis Pharmaceuticals
Early Breast Cancer, Hormone Receptor Positive Tumor
Adherence to Aromatase Inhibitors ± Abemaciclib Treatment in Patients With Early-stage HER2-negative Breast Cancer
Around 90% of breast cancer patients are diagnosed at an early stage and approximately 70% are hormone receptor-positive and HER2-negative (HR+/HER2-).
- Conditions
- Early Breast Cancer, Hormone Receptor Positive Tumor, HER2-negative Breast Cancer
- Trial name
- ONCO-Adher (NCT06650423)
- Where
- Slovenia
- Volunteers
- 319 people
- Sponsor
- Institute of Oncology Ljubljana
Breast Cancer
RADIANT: Pre-op Radiation With Abemaciclib and Letrozole
This phase 1b study investigates the safety and feasibility of combining pre-operative radiation therapy with Cyclin-Dependent Kinase 4 (CDK4/6) inhibitors in participants with hormone receptor positive/HER2 negative (HR+/HER2-)…
- Trial name
- NCT06139107
- Testing
- Abemaciclib, Letrozole
- Where
- 4 sites in United States
- Volunteers
- 15 people
- Sponsor
- Mridula George, MD
Breast Cancer
NEOadjuvant Abemaciclib and GIredestrant TriaL in Patients with ER-positive, HER2-negative Early Breast Cancer
The objective of the study is to evaluate the efficacy and the safety of abemaciclib and giredestrant before surgery in participants with early stage, oestrogen receptor-positive (ER+), human epidermal receptor 2 negative (HER2-)…
- Trial name
- Neo-AGILE (NCT06259929)
- Testing
- Abemaciclib 150 MG + Giredestrant 30 MG
- Where
- 8 sites in Italy
- Volunteers
- 51 people
- Sponsor
- Fondazione Oncotech
Breast Neoplasms, Triple Negative Breast Neoplasms
Clinical and Therapeutic Outcomes by Molecular Subtype in Breast Cancer
Breast cancer is the most common cancer in women worldwide. Its molecular classification, based on hormone receptors (estrogen and progesterone), HER2 and Ki-67, defines subtypes with different prognoses and treatments.
- Conditions
- Breast Neoplasms, Triple Negative Breast Neoplasms, HER2-Positive Breast Cancer, Hormone Receptor-Positive Breast Cancer
- Trial name
- NCT07856225
- Testing
- CDK4/6 Inhibitors, Anti-HER2 Therapy, Standard Breast Cancer Treatment
- Where
- Colombia
- Volunteers
- 370 people
- Sponsor
- Fundación Santa Fe de Bogota
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 Neoplasms, Hormone Receptor-Positive Breast Cancer
Observational Study of Gut Microbiota in Abemaciclib-Treated Patients With and Without Diarrhea
Why is this study being done? Many patients with a type of breast cancer (called HR-positive) take a medicine called Abemaciclib.
- Conditions
- Breast Neoplasms, Hormone Receptor-Positive Breast Cancer, Abemaciclib, Abemaciclib-related Diarrhea
- Trial name
- NCT07264998
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Hubei Cancer Hospital
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer
This phase II trial tests the accuracy of functional imaging (FFNP)-positron emission tomography (PET)/computed tomography (CT) to predict response to abemaciclib plus endocrine therapy.
- Conditions
- Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Locally Advanced Unresectable HER2-Negative Breast Carcinoma, Locally Advanced Unresectable Hormone Receptor-Positive Breast Carcinoma
- Trial name
- NCT06179303
- Testing
- Abemaciclib, Anastrozole, Biospecimen Collection
- Where
- 3 sites in United States
- Volunteers
- 60 people
- Sponsor
- University of Washington
Neoplasms, Child
A Master Protocol (LY900023) That Includes Several Clinical Trials of Drugs for Children and Young Adults With Cancer
The main purpose of the master is to help the research sites and sponsor carry out several clinical trials more efficiently by providing a common research protocol.
- Conditions
- Neoplasms, Child, Adolescent
- Trial name
- CAMPFIRE (NCT05999994)
- Testing
- Ramucirumab, Cyclophosphamide, Vinorelbine
- Where
- 72 sites in United States, Australia and 8 more
- Volunteers
- 105 people
- Sponsor
- Eli Lilly and Company
Breast Cancer, Adjuvant Therapy
Chemo-free in Older (≥65) Node-Positive ER+/HER2- Breast Cancer
This study is a prospective, open-label, multicenter, randomized controlled Phase III clinical trial. Based on the use of CDK4/6 inhibitors in endocrine-sensitive luminal-type (ER+/HER2-) breast cancer, it aims to explore the…
- Trial name
- SENIOR (NCT07005557)
- Testing
- Chemotherapy, CDK4/6 Inhibitor, Endocrine therapy
- Volunteers
- 1,244 people
- Sponsor
- Fudan University