Clinical trials: Abemaciclib, open to volunteers
Male Breast Cancer, Hormone Receptor-positive Breast Cancer
ETHAN - ET for Male BC
This research study is looking to see how well male breast cancer responds to preoperative treatment with endocrine therapy and which endocrine therapy regimen is the most effective treatment for male breast cancer.
- Conditions
- Male Breast Cancer, Hormone Receptor-positive Breast Cancer, Hormone Receptor Negative Breast Carcinoma
- Trial name
- NCT05501704
- Testing
- Tamoxifen, Anastrozole, Degarelix
- Where
- 9 sites in United States
- Volunteers
- 60 people
- Sponsor
- Jose Pablo Leone
Breast Cancer
Single Cell Immune and Non-immune Correlates of Response to Neoadjuvant Abemaciclib
The purpose of this study is to better understand how the immune system plays a role in fighting breast cancer and specifically research if the immune system response against breast cancer can be improved with endocrine therapy…
- Trial name
- NCT04614194
- Testing
- Letrozole, Abemaciclib
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- University of Texas Southwestern Medical Center
HER2-negative Breast Cancer, Hormone-receptor-positive Breast Cancer
DiviTum®TKa: A Biomarker Assay for Efficacy in HR+ Breast Cancer Patients
This study is being done to determine if there is a pattern associated with response to endocrine therapy alone and in combination with CDK4/6 inhibitor used for hormone receptor positive HER2 negative breast cancer.
- Conditions
- HER2-negative Breast Cancer, Hormone-receptor-positive Breast Cancer, Metastatic Breast Cancer, Anatomic Stage II Breast Cancer AJCC v8
- Trial name
- NCT06388122
- Testing
- Biospecimen Collection
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Mayo Clinic
Breast Cancer
Real-world Evaluation of Patient Outcomes and Experiences With Ribociclib Early Adopters.
This non-interventional study (NIS) aims to evaluate effectiveness, persistence, treatment patterns, adverse events (AEs), and patient-reported experience (including adherence, treatment satisfaction, health-related quality of…
- Trial name
- REPOWER (NCT07243002)
- Where
- United Kingdom
- Volunteers
- 3,000 people
- Sponsor
- Novartis Pharmaceuticals
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors
This phase I trial tests the safety, side effects, and best dose of ZEN003694 when given together with abemaciclib in treating patients with NUT carcinoma, breast cancer or other solid tumors that have spread from where it first…
- Conditions
- Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Metastatic Malignant Solid Neoplasm
- Trial name
- NCT05372640
- Testing
- Abemaciclib, BET Bromodomain Inhibitor ZEN-3694, Biopsy Procedure
- Where
- 7 sites in United States
- Volunteers
- 45 people
- Sponsor
- National Cancer Institute (NCI)
Breast Neoplasms, Breast Cancer
I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer
The purpose of this study is to further advance the ability to practice personalized medicine by learning which new drug agents are most effective with which types of breast cancer tumors and by learning more about which early…
- Conditions
- Breast Neoplasms, Breast Cancer, Breast Tumors, Angiosarcoma
- Trial name
- I-SPY (NCT01042379)
- Testing
- Standard Therapy, AMG 386 with or without Trastuzumab, AMG 479 (Ganitumab) plus Metformin
- Where
- 42 sites in United States
- Volunteers
- 5,000 people
- Sponsor
- QuantumLeap Healthcare Collaborative
Brain Metastases, HR+ Metastatic Breast Cancer
SRS & Abemaciclib w/wo Imlunestrant in the Management of HR+/HER2- Breast CA Brain Metastases
This is a single arm study of abemaciclib and endocrine therapy with stereotactic radiosurgery (SRS) among patients with hormone receptor (HR)+/HER2- metastatic breast cancer brain metastases.
- Trial name
- NCT04923542
- Testing
- Stereotactic Radiosurgery (SRS), Abemaciclib, Endocrine therapy
- Where
- 2 sites in United States
- Volunteers
- 31 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
HR+/HER2- Early Breast Cancer
IMPLEMENTING PATIENTS' COMPETENCE IN ORAL EBC THERAPY PERSISTENCE
The goal of this interventional study is to evaluate the effect of standardized patient coaching on treatment adherence among patients taking abemaciclib.
- Trial name
- IMPACT PT (NCT07521202)
- Testing
- Standardized patient coaching
- Where
- Germany
- Volunteers
- 257 people
- Sponsor
- Institut fuer Frauengesundheit
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
Breast Neoplasms, Carcinoma, Ductal, Breast
Signatera-Guided CDK4/6 Inhibitor Therapy in Breast Cancer
The purpose of this study is to evaluate the efficacy and safety of ctDNA-guided initiation of CDK4/6 inhibitor therapy using the Signatera™ Designed on Genome test (referred to as "Signatera Genome") in participants with…
- Conditions
- Breast Neoplasms, Carcinoma, Ductal, Breast, Receptors, Estrogen (for ER-positive Requirement)
- Trial name
- SIGNAL-ER 101 (NCT07214532)
- Testing
- ctDNA-Guided Treatment Strategy
- Where
- 49 sites in United States
- Volunteers
- 725 people
- Sponsor
- Natera, Inc.
Anatomic Stage IV Breast Cancer AJCC v8, Metastatic HER2-Negative Breast Carcinoma
A Vaccine (STEMVAC) With Standard Endocrine-Based Therapy or Chemotherapy for the Treatment of Metastatic Hormone Receptor Positive, HER2 Negative Breast Cancer
This phase II trial studies how well a vaccine, STEMVAC, works in combination with standard endocrine-based therapy (ET) with a CDK4/6 targeted drug therapy, or with the chemotherapy drug capecitabine, in treating patients with…
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, Metastatic HER2-Negative Breast Carcinoma, Metastatic Hormone Receptor-Positive Breast Carcinoma
- Trial name
- NCT07112053
- Testing
- CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine, Capecitabine, Computed Tomography
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of Washington
Breast Cancer
Immunomonitoring of Breast Cancer Patients During Systemic Treatment
This study aims to constitute a most complete biological collection for patients treated for localized or metastatic breast cancer (in different cohorts depending on the type of systemic treatment received), in order to describe…
- Trial name
- IMMUNE CAPTURE (NCT04925856)
- Testing
- blood sample
- Where
- 2 sites in France
- Volunteers
- 150 people
- Sponsor
- Centre Georges Francois Leclerc
Chondrosarcoma, Osteosarcoma
Abemaciclib for Bone and Soft Tissue Sarcoma With Cyclin-Dependent Kinase (CDK) Pathway Alteration
This is a single-arm, phase II study that will enroll a total of 45 subjects. All subjects will have a confirmed diagnosis of metastatic or unresectable soft tissue sarcoma or bone sarcoma.
- Conditions
- Chondrosarcoma, Osteosarcoma, Soft Tissue Sarcoma
- Trial name
- NCT04040205
- Testing
- Abemaciclib
- Where
- 4 sites in United States
- Volunteers
- 44 people
- Sponsor
- Medical College of Wisconsin
Metastatic Breast Cancer, Stage IV Breast Cancer
A Study of Abemaciclib and Radiation Therapy in People With Metastatic Breast Cancer
The purpose of this study is to test different doses of abemaciclib to find the best dose in participants while receiving hormone therapy and radiation therapy.
- Conditions
- Metastatic Breast Cancer, Stage IV Breast Cancer, Breast Cancer, Breast Cancer Stage IV
- Trial name
- NCT06678269
- Testing
- Abemaciclib, Radiation Therapy
- Where
- 7 sites in United States
- Volunteers
- 28 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Breast Cancer
Chemotherapy Omission in ER+/HER2- Breast Cancer With 1-3 Positive Lymph Nodes Receiving Extended Adjuvant Abemaciclib
This is a prospective, randomized, open-label, multicenter phase III study to explore chemotherapy omission in ER+/HER2-endocrine-sensitive breast cancer with 1-3 positive lymph nodes receiving extended (3 year) adjuvant…
- Trial name
- Rainbow (NCT06341621)
- Testing
- 3-year abemaciclib without chemo, treatment of physician's choice
- Where
- China
- Volunteers
- 1,900 people
- Sponsor
- Fudan University
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
Breast Cancer
Real-world Data in Patients With Breast Cancer Treated With Abemaciclib
The present study will assess real-world clinical outcomes and adverse events from treatment with endocrine therapy combined with abemaciclib in patients with HR-positive, HER2-negative advanced breast cancer.
- Trial name
- ENDURANCE (NCT04985058)
- Where
- Greece
- Volunteers
- 108 people
- Sponsor
- Hellenic Cooperative Oncology Group
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
Advanced Breast Cancer
Iparomlimab and Tuvonralimab (QL1706) in Patients With HR-positive, HER2-negative Advanced Breast Cancer
This is a prospective, randomised, controlled, multicentre study to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab (QL1706) in patients with hormone receptor-positive/human epidermal growth factor receptor…
- Trial name
- ITHRAN (NCT07180160)
- Testing
- QL1706, CDK4/6 inhibitor, Fulvestrant
- Where
- China
- Volunteers
- 123 people
- Sponsor
- Wenjin Yin
HR+/HER2- Breast Cancer
Abemaciclib Dose Escalation in Early High-Risk Breast Cancer Adjuvant Therapy
Abemaciclib combined with endocrine therapy has become one of the important adjuvant treatment regimens for patients with HR+/HER2- high-risk early breast cancer.
- Trial name
- ADES (NCT07599137)
- Testing
- Dose escalation
- Volunteers
- 86 people
- Sponsor
- Peking University Cancer Hospital & Institute