Clinical trials: CDK4/6 Inhibitor
Metastatic Breast Cancer
Pembrolizumab + Paclitaxel in HR+/HER2- Non-luminal (by PAM50) Advanced Breast Cancer After CDK4/6 Inhibitor Progression
This is an open-label, single arm, multicenter phase II study evaluating treatment with pembrolizumab in combination with paclitaxel in patients with locally advanced or metastatic non-luminal hormone receptor-positive (HR+)…
- Trial name
- TATEN (NCT04251169)
- Testing
- Pembrolizumab, Paclitaxel
- Where
- 7 sites in Spain
- Volunteers
- 20 people
- Sponsor
- SOLTI Breast Cancer Research Group
Breast Neoplasms
A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2)
The study is designed to compare the clinical benefit following treatment with letrozole in combination with PD-0332991 versus letrozole in combination with placebo in postmenopausal women with ER(+)/HER2(-) advanced breast…
- Trial name
- NCT01740427
- Testing
- PD-0332991, Letrozole
- Where
- 305 sites in United States, Australia and 16 more
- Volunteers
- 666 people
- Sponsor
- Pfizer
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.
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
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
Hormone Receptor Positive Malignant Neoplasm of Breast, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
Palbociclib in Combination With Tamoxifen as First Line Therapy for Metastatic Hormone Receptor Positive Breast Cancer
This is a non-randomized, open-label, single-arm, multicenter, phase II study of palbociclib in combination with tamoxifen in women with HR(+)/HER2(-) advanced breast cancer who have not received prior systemic anticancer…
- Conditions
- Hormone Receptor Positive Malignant Neoplasm of Breast, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, Estrogen Receptor Positive Breast Cancer, Progesterone Receptor Positive Tumor
- Trial name
- NCT02668666
- Testing
- Palbociclib, Tamoxifen
- Where
- 7 sites in United States
- Volunteers
- 49 people
- Sponsor
- Oana Danciu, MD
Breast Cancer, Metastatic Breast Cancer
Prognostic Impact of the Neutrophil/Lymphocyte Ratio (NLR) in the Treatment of First-line Metastatic or Locally Advanced Breast Cancer Treated With CDK4/6 Inhibitor.
The impact of the inflammatory microenvironment in predicting the benefit of a CDK4/6 inhibitor in the treatment of locally advanced or first line metastatic breast cancer has not yet been studied.
- Trial name
- PEPSI (NCT05303129)
- Testing
- Blood sampling
- Where
- 2 sites in France
- Volunteers
- 165 people
- Sponsor
- Centre Francois Baclesse
Urothelial Carcinoma, Bladder Cancer
Trilaciclib, a CDK 4/6 Inhibitor, in Patients With Advanced/Metastatic Bladder Cancer Receiving Chemotherapy Then Avelumab
This is a Phase 2, multicenter, randomized, open-label study evaluating the safety and efficacy of trilaciclib administered with platinum-based chemotherapy followed by trilaciclib administered with avelumab maintenance therapy…
- Conditions
- Urothelial Carcinoma, Bladder Cancer, Myelosuppression Adult, Chemotherapy-induced Neutropenia
- Trial name
- PRESERVE3 (NCT04887831)
- Testing
- Trilaciclib, Gemcitabine, Cisplatin
- Where
- 34 sites in United States, France and 3 more
- Volunteers
- 92 people
- Sponsor
- G1 Therapeutics, Inc.
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
Breast Cancer
A Study of Nonsteroidal Aromatase Inhibitors Plus Abemaciclib (LY2835219) in Postmenopausal Women With Breast Cancer
The main purpose of this study is to evaluate how effective nonsteroidal aromatase inhibitors (NSAI) plus abemaciclib are in postmenopausal women with breast cancer.
- Trial name
- MONARCH 3 (NCT02246621)
- Testing
- Abemaciclib, Anastrozole, Letrozole
- Where
- 155 sites in United States, Australia and 20 more
- Volunteers
- 493 people
- Sponsor
- Eli Lilly and Company
Advanced Breast Cancer
Palbociclib Pharmacokinetics Study In Postmenopausal Chinese Women With ER (+), HER2 (-) Advanced Breast Cancer
As part of the global clinical development program for Palbociclib, studies are planned in cancer patients in China. An assessment of Palbociclib pharmacokinetics in Chinese patients, as required by the Chinese Health…
- Trial name
- NCT02499146
- Testing
- Palbociclib, Letrozole
- Where
- 7 sites in China
- Volunteers
- 26 people
- Sponsor
- Pfizer
Advanced Cancer, Metastatic Cancer
A Study of Abemaciclib (LY2835219) in Native Chinese Participants With Advanced and/or Metastatic Cancers
The purpose of this study is to determine the safety of the study drug known as abemaciclib in native Chinese participants with advanced and/or metastatic cancers.
- Trial name
- NCT02919696
- Testing
- Abemaciclib
- Where
- 3 sites in China
- Volunteers
- 26 people
- Sponsor
- Eli Lilly and Company
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
Breast Cancer
Phase 3 Trial of Elacestrant Versus Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer
This Phase 3 clinical study compares the efficacy and safety of elacestrant to the standard of care (SoC) options of fulvestrant or an aromatase inhibitor (AI) in women and men with breast cancer whose disease has advanced on at…
- Trial name
- EMERALD (NCT03778931)
- Testing
- Elacestrant, Standard of Care
- Where
- 244 sites in United States, Argentina and 15 more
- Volunteers
- 478 people
- Sponsor
- Stemline Therapeutics, Inc.
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 Breast Cancer
Study of Efficacy and Safety of LEE011 in Men and Postmenopausal Women With Advanced Breast Cancer.
The main aim of this study was to evaluate the efficacy and safety of adding ribociclib to fulvestrant in men and postmenopausal women with hormone receptor positive (HR+), HER2-negative advanced breast cancer.
- Trial name
- MONALEESA-3 (NCT02422615)
- Testing
- Ribociclib, Fulvestrant
- Where
- 174 sites in United States, Australia and 28 more
- Volunteers
- 726 people
- Sponsor
- Novartis Pharmaceuticals
Small Cell Lung Cancer
Trilaciclib (G1T28) in Patients With Previously Treated Extensive Stage SCLC Receiving Topotecan Chemotherapy
This was a study to investigate the potential clinical benefit of trilaciclib (G1T28), a Cyclin Dependent Kinase (CDK) 4/6 inhibitor, in preserving the bone marrow and the immune system, in order to decrease chemotherapy-induced…
- Trial name
- NCT02514447
- Testing
- Trilaciclib, Topotecan
- Where
- 50 sites in United States, Belgium and 6 more
- Volunteers
- 123 people
- Sponsor
- G1 Therapeutics, Inc.