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
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
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
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.
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
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.
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.
Advanced Solid Tumor, Advanced Breast Cancer
A Phase 1 Study of BMS-986500 as Monotherapy or Combination Therapy in Advanced Solid Tumors
The purpose of this study is to assess BMS-986500 as monotherapy in advanced solid tumors and as combination therapy in CDK4/6 inhibitor pre-treated advanced breast cancer.
- Conditions
- Advanced Solid Tumor, Advanced Breast Cancer, Advanced Ovarian Cancer
- Trial name
- NCT06997029
- Testing
- BMS-986500, Palbociclib, Fulvestrant
- Where
- 21 sites in United States, Denmark and 1 more
- Volunteers
- 234 people
- Sponsor
- Bristol-Myers Squibb
Advanced Breast Cancer
A Study of SHR6390 in Combination With Letrozole or Anastrozole or Fulvestrant in Patients With HR Positive and HER2 Negative Advanced Breast Cancer
This is a phase IB/II clinical trial to evaluate the efficacy and safety of SHR6390 in combination with Letrozole or Anastrozole or Fulvestrant.
- Trial name
- NCT03481998
- Testing
- SHR6390, Letrozole or anastrozole or Fulvestrant
- Where
- 4 sites in China
- Volunteers
- 104 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Advanced Breast Cancer
Study to Assess the Safety of Alpelisib Plus Fulvestrant, in Men and Post-menopausal Women With HR-positive, HER2-negative, Advanced Breast Cancer (aBC) With PIK3CA Mutation, Whose Disease Progressed on or After Endocrine Treatment
The purpose of this study was to determine the safety of alpelisib plus fulvestrant in men and post-menopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, advanced or…
- Trial name
- ALPINIST (NCT05631795)
- Testing
- Alpelisib, Fulvestrant
- Where
- 12 sites in India
- Volunteers
- 40 people
- Sponsor
- Novartis Pharmaceuticals
Myelosuppression Adult, Chemotherapeutic Toxicity
Expanded Access to Trilaciclib for Patients Receiving Chemotherapy for Small Cell Lung Cancer
The purpose of this expanded access protocol is to provide access to trilaciclib for chemotherapy-induced myelosuppression in patients receiving chemotherapy as a treatment for small cell lung cancer (SCLC).
- Conditions
- Myelosuppression Adult, Chemotherapeutic Toxicity, Small Cell Lung Cancer
- Trial name
- NCT04504513
- Testing
- Trilaciclib
- Sponsor
- G1 Therapeutics, Inc.
Breast Cancer
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-0587 as a Monotherapy and in Combination With Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer
This is a first-in-human, Phase Ia/Ib, dose-escalation and expansion study evaluating the safety, pharmacokinetics, and activity of GDC-0587 (cyclin-dependent kinase-4 [CDK4] inhibitor) as a monotherapy and in combination with…
- Trial name
- NCT07214662
- Testing
- GDC-0587, Giredestrant, Omeprazole
- Where
- 4 sites in United States, Taiwan
- Volunteers
- 3 people
- Sponsor
- Genentech, Inc.
Breast Cancer
Study of Ribociclib With Everolimus + Exemestane in HR+ HER2- Locally Advanced/Metastatic Breast Cancer Post Progression on CDK 4/6 Inhibitor.
The purpose of this study is determine if the triplet combination of ribociclib, everolimus and exemastane is safe and effective in the treatment of locally advanced/metastatic breast cancer following treatment with a CDK 4/6…
- Trial name
- TRINITI-1 (NCT02732119)
- Testing
- Ribociclib, Everolimus, Exemestane
- Where
- 25 sites in United States
- Volunteers
- 104 people
- Sponsor
- Novartis Pharmaceuticals
Breast Neoplasms
A Study Of Palbociclib (PD-0332991) + Letrozole VS. Placebo+ Letrozole For 1st Line Treatment Of Asian Postmenopausal Women With ER+/HER2- Advanced Breast Cancer [PALOMA-4]
The study is designed to compare the clinical benefit following treatment with letrozole in combination with Palbociclib versus letrozole in combination with placebo in Asian postmenopausal women with ER(+)/HER2(-) advanced…
- Trial name
- NCT02297438
- Testing
- Palbociclib, Letrozole
- Where
- 54 sites in China, Hong Kong and 3 more
- Volunteers
- 340 people
- Sponsor
- Pfizer
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
Advanced Metastatic Breast Cancer
Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer
The purpose of this study was to determine whether treatment with tamoxifen or a non-steroidal aromatase inhibitors (NSAI) + goserelin + LEE011 prolonged progression-free survival (PFS) compared to treatment with tamoxifen or a…
- Trial name
- MONALEESA-7 (NCT02278120)
- Testing
- Ribociclib, Tamoxifen, Letrozole
- Where
- 183 sites in United States, Argentina and 28 more
- Volunteers
- 672 people
- Sponsor
- Novartis Pharmaceuticals