Clinical trials: CDK4/6 Inhibitor
Metastatic Breast Cancer
A Study of Abemaciclib (LY2835219) in Combination With Fulvestrant Compared to Chemotherapy in Women With HR Positive, HER2 Negative Metastatic Breast Cancer
The reason for this study is to compare the efficacy of abemaciclib, in combination with fulvestrant, to that of physician's choice of chemotherapy in women with hormone receptor-positive (HR+), human epidermal growth factor…
- Trial name
- NCT04031885
- Testing
- Abemaciclib, Fulvestrant, Standard Chemotherapy
- Where
- 61 sites in United States, Puerto Rico
- Volunteers
- 4 people
- Sponsor
- Eli Lilly and Company
Breast Cancer
Chemotherapy Omission in HR-positive/HER2-negative Breast Cancer With Lymph Node Negative Disease Receiving Adjuvant Endocrine Therapy and CDK4/6 Inhibitor
This is a prospective, randomized, open-label, multicenter phase III study to explore chemotherapy omission in hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer with lymph node…
- Trial name
- NCT06996093
- Testing
- 4 cycles of TC (docetaxel + cyclophosphamide) adjuvant chemotherapy, aromatase inhibitor (± ovarian suppression) plus CDK4/6 inhibitor
- Where
- China
- Volunteers
- 2,508 people
- Sponsor
- Fudan University
Advanced, Metastatic Breast Cancer
A Study to Investigate the Efficacy and Safety of Letrozole SIE Compared With Femara® (Both Combined With the CDK4/6 Inhibitor Ribociclib) in Postmenopausal Women With HR-Positive, HER2-Negative, Inoperable Locally Advanced or Metastatic Breast Cancer
The purpose of this study is to evaluate the efficacy and safety of Letrozole SIE (injectable) compared to Femara® (oral tablet), both given together with ribociclib, for the first-line treatment of postmenopausal women with…
- Trial name
- SIE-3 (NCT07340658)
- Volunteers
- 300 people
- Sponsor
- Rovi Pharmaceuticals Laboratories
Breast Cancer, Hormone Receptor-positive Breast Cancer
A Randomized Study Comparing the Immune Modulation Effect of Ribociclib, Palbociclib, and Abemaciclib in ER+/HER2- EBC
The 3 FDA-approved CDK4, 6 inhibitors, palbociclib, ribociclib, and abemciclib, all provided progression-free survival benefits when combined with endocrine therapy in advanced ER+/HER2- breast cancer.
- Conditions
- Breast Cancer, Hormone Receptor-positive Breast Cancer, Hormone Therapy
- Trial name
- ORACLE-RIPA (NCT05766410)
- Testing
- Palbociclib, Ribociclib, Abemaciclib
- Where
- 2 sites in Taiwan
- Volunteers
- 60 people
- Sponsor
- National Taiwan University Hospital
Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer
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)
This is a Phase III, randomized, open-label multicenter study that will evaluate the efficacy and safety of giredestrant compared with fulvestrant, both in combination with the investigator's choice of a CDK4/6 inhibitor…
- Trial name
- NCT06065748
- Testing
- Giredestrant, Fulvestrant, Abemaciclib
- Where
- 311 sites in United States, Argentina and 35 more
- Volunteers
- 1,050 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
A Real-World Study of Treatment Patterns, Tolerability and Effectiveness of CDK4/6 Inhibition in HR+, HER2-negative Metastatic Breast Cancer Patients
The aim of this study was to assess real-world treatment patterns and tolerability of ribociclib among patient populations historically underrepresented in clinical trials - specifically older adults and Black/African American…
- Trial name
- NCT07760714
- Where
- United States
- Volunteers
- 945 people
- Sponsor
- Novartis Pharmaceuticals
HER2-positive Breast Cancer, Postmenopausal
Phase IB & II Study of Ribociclib With Trastuzumab Plus Letrozole in Postmenopausal HR+, HER2+ Advanced Breast Cancer Patients
Survival benefit and quality of life are two key elements that should be kept in mind in the treatment of metastatic breast cancer.
- Conditions
- HER2-positive Breast Cancer, Postmenopausal, Metastatic Breast Cancer
- Trial name
- NCT03913234
- Testing
- Ribociclib, Trastuzumab, Letrozole
- Where
- South Korea
- Volunteers
- 95 people
- Sponsor
- Yonsei University
Metastatic Breast Cancer
ELACESTRANT in Women and Men With CDK4/6 Inhibitor-Naive Estrogen Receptor Positive, HER-2 Negative Metastatic Breast Cancer Study
The purpose of this study is to evaluate the efficacy and safety of elacestrant over the course of 6 months in patients with estrogen receptor positive (ER+)/human epidermal growth factor receptor-2 negative (HER2-)…
- Trial name
- ELCIN (NCT05596409)
- Testing
- Elacestrant
- Where
- 22 sites in United States, Brazil and 4 more
- Volunteers
- 61 people
- Sponsor
- Stemline Therapeutics, Inc.
Metastatic Breast Cancer
A Study of Abemaciclib (LY2835219) in Participants With HR+, HER2- Advanced Breast Cancer
The reason for this study is to see if the drug abemaciclib in combination with nonsteroidal aromatase inhibitors (anastrozole or letrozole) is effective in participants with Hormone Receptor Positive (HR+), Human Epidermal…
- Trial name
- proMONARCH (NCT03988114)
- Testing
- Abemaciclib, Nonsteroidal Aromatase Inhibitor (NSAI)
- Where
- 119 sites in United States, Argentina and 7 more
- Sponsor
- Eli Lilly and Company
Carcinoma, Non-Small-Cell Lung, Lung Cancer
G1T38, a CDK 4/6 Inhibitor, in Combination With Osimertinib in EGFR-Mutant Non-Small Cell Lung Cancer
This was a study to investigate the potential clinical benefit of G1T38 as an oral therapy in combination with osimertinib in patients with EGFR mutation-positive metastatic non-small cell lung cancer.
- Conditions
- Carcinoma, Non-Small-Cell Lung, Lung Cancer, Non-small Cell Lung Cancer
- Trial name
- NCT03455829
- Testing
- G1T38, Osimertinib
- Where
- 8 sites in United States
- Volunteers
- 30 people
- Sponsor
- G1 Therapeutics, Inc.
HER2-positive Advanced Breast Cancer
T-DM1 Combined With CDK4/6 Inhibitor Ribociclib
To explore the efficacy and safety of T-DM1 combined with CDK4/6 inhibitor Ribociclib in the treatment of HER2-positive advanced breast cancer.
- Trial name
- NCT06481956
- Testing
- Ribociclib Oral Tablet
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Zheng Yabing
Mantle Cell Lymphoma
Study of LY2835219 for Mantle Cell Lymphoma
The purpose of this study is to estimate the disease control rate with abemaciclib for relapsed or refractory mantle cell lymphoma.
- Trial name
- NCT01739309
- Testing
- Abemaciclib
- Where
- 7 sites in France, Germany
- Volunteers
- 28 people
- Sponsor
- Eli Lilly and Company
Hormonal Receptors Positive, HER2 Negative, Advanced Breast Cancer
Prediction of Treatment Efficacy of the Combination of Palbociclib/(Letrozole or Anastrozole) in First Line Metastatic Women With Luminal, HER2 Negative Advanced Breast Cancer, Using Infrared Laser Spectroscopy Analysis on Liquid Biopsies.
This study is a multicenter, international, open-label phase II study. Based on inclusion/exclusion criteria, eligible pre and postmenopausal patients with newly diagnosed metastatic luminal hormone receptor-positive and HER2…
- Trial name
- ICRG0201 (NCT05190094)
- Testing
- Combination of Palbociclib and aromatase inhibitor (Letrozole or Anastrozole)
- Where
- 7 sites in Algeria, Jordan and 1 more
- Volunteers
- 80 people
- Sponsor
- International Cancer Research Group, United Arab Emirates
Triple Negative Breast Cancer, Breast Cancer
Trilaciclib, a CDK4/6 Inhibitor, in Patients With Early-Stage Triple Negative Breast Cancer
The purpose of this study is to evaluate the mechanism of action, as well as the safety and efficacy of trilaciclib in combination with standard of care treatment in the neoadjuvant setting of early-stage triple negative breast…
- Trial name
- NCT05112536
- Testing
- Trilaciclib, Cylophosphamide, Doxorubicin
- Where
- 7 sites in United States
- Volunteers
- 24 people
- Sponsor
- G1 Therapeutics, Inc.
Anatomic Stage IV Breast Cancer AJCC v8, Metastatic HER2-Negative Breast Carcinoma
Tka Assay for CDK4/6i
This clinical trial assesses whether using a test developed by DiviTum can identify optimal levels of CDK 4/6 inhibitor medications in the blood and whether assessing medical compliance and drug-drug interactions can optimize…
- Trial name
- NCT06572800
- Testing
- DiviTum-TKa
- Where
- 18 sites in United States
- Volunteers
- 34 people
- Sponsor
- Yale University
The Efficacy of Abiraterone Acetate Combined With Dalpicilib in the Treatment of Patients With Metastatic Castration-resistant Prostate Cancer
Darxicilib Combined With Abiraterone Acetate Tablets (II) for the Treatment of Advanced Metastatic Castration-resistant Prostate Cancer.
This study is a single-arm, multicenter, phase II exploratory trial. The purpose is to explore the efficacy and safety of Darxicilib in combination with Abiraterone Acetate for the treatment of subjects with metastatic…
- Trial name
- NCT06500247
- Testing
- Dalpicilib, Abiraterone Acetate (II), Androgen Deprivation Therapy
- Where
- China
- Volunteers
- 43 people
- Sponsor
- Qilu Hospital of Shandong University
Solid Tumor, Solid Tumor, Adult
A Study With NKT3447 for Adults With Advanced/Metastatic Solid Tumors
The goal of the Dose Escalation phase of the study is to evaluate the safety, tolerability, and pharmacokinetics (PK) to determine the maximum tolerated dose (MTD) and/or preliminary recommended dose for expansion (RDE) of…
- Conditions
- Solid Tumor, Solid Tumor, Adult, Advanced Solid Tumor, Metastatic Tumor
- Trial name
- NCT06264921
- Testing
- NKT3447
- Where
- 8 sites in United States
- Volunteers
- 23 people
- Sponsor
- NiKang Therapeutics, Inc.
Relapsed Acute Leukemia, Refractory Acute Leukemia
A Phase 1 Trial of TST of PD 0332991 Followed by Cytarabine and Mitoxantrone for Adults With Relapsed and Refractory Acute Leukemias and High-Risk Myelodysplasia
1.1 Primary Objectives To determine the feasibility, tolerability, and toxicities of administering the selective CDK 4/6 inhibitor PD 0332991 prior to the combination of ara-C and Mitoxantrone for adults with relapsed and…
- Conditions
- Relapsed Acute Leukemia, Refractory Acute Leukemia, High-Risk Myelodysplasia
- Trial name
- NCT01701375
- Testing
- PD 0332991
- Where
- 2 sites in United States
- Volunteers
- 2 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Breast Cancer
Pyrotinib, Dalpiciclib(SHR6390) and Endocrine Therapy in Subjects With Dual-receptor Positive(ER+/HER2+) Advanced Breast Cancer
This is a single-center Ib / II study of triple targeted drug combination (endocrine therapy，novel HER2-targeted small molecule inhibitor pyrotinib and CDK4/6 inhibitor dalpiciclib(SHR6390) ) as a first or second line of therapy…
- Trial name
- PLEASURABLE (NCT03772353)
- Testing
- Dalpiciclib, Pyrotinib, Letrozole
- Where
- China
- Volunteers
- 59 people
- Sponsor
- Fudan University
Breast Cancer Metastatic
PARP Inhibitor With CDK4/6 Inhibitor and Endocrine Therapy in HR+/ HER2-Advanced Breast Cancer
This study is a prospective, open-label, phase II clinical study for patients with HR+/HER2- advanced breast cancer.
- Trial name
- NCT05759546
- Testing
- Fluzoparib, Dalpiciclib, Fulvestrant/AI
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Fudan University