Clinical trials: CDK4/6 Inhibitor
Locally Advanced or Metastatic Breast Cancer
Safety and Efficacy of SPH4336 in Combination With Endocrine Therapy in the Treatment of Locally Advanced or Metastatic Breast Cancer
This study evaluated the safety and efficacy of SPH4336 in combination with endocrine therapy in the treatment of locally advanced or metastatic breast cancer that progressed on CDK4/6 inhibitor combined with endocrine therapy.
- Trial name
- NCT05860465
- Testing
- SPH4336 Tablets
- Where
- 22 sites in China
- Volunteers
- 254 people
- Sponsor
- Shanghai Pharmaceuticals Holding Co., Ltd
Breast Cancer, Hormonreceptor Positive
A Study of Palbociclib in Addition to Standard Endocrine Treatment in Hormone Receptor Positive Her2 Normal Patients With Residual Disease After Neoadjuvant Chemotherapy and Surgery
The PENELOPEB study is designed to demonstrate that, in the background of standard anti-hormonal therapy, palbociclib provides superior invasive disease-free survival (iDFS) compared to placebo in pre- and postmenopausal women…
- Conditions
- Breast Cancer, Hormonreceptor Positive, Her2-normal, Postneoadjuvant Treatment With CDK 4/6 Inhibitor
- Trial name
- PENELOPE-B (NCT01864746)
- Testing
- Palbociclib PD-0332991
- Where
- 11 sites in United States, Australia and 9 more
- Volunteers
- 1,250 people
- Sponsor
- GBG Forschungs GmbH
Breast Neoplasms
A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer
The main purpose of this study is to compare progression-free survival for women with hormone receptor positive (HR+), human epidermal growth factor receptor (HER2) negative advanced breast cancer receiving either abemaciclib +…
- Trial name
- MONARCH 2 (NCT02107703)
- Testing
- Abemaciclib, Fulvestrant
- Where
- 146 sites in United States, Australia and 18 more
- Volunteers
- 669 people
- Sponsor
- Eli Lilly and Company
TNBC - Triple-Negative Breast Cancer, Breast Cancer
Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving Gemcitabine and Carboplatin for Metastatic Triple-Negative Breast Cancer (TNBC)
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of trilaciclib versus placebo administered prior to gemcitabine and carboplatin in patients receiving first- or…
- Trial name
- PRESERVE 2 (NCT04799249)
- Testing
- Trilaciclib, Gemcitabine, Carboplatin
- Where
- 71 sites in United States, Australia and 9 more
- Volunteers
- 194 people
- Sponsor
- G1 Therapeutics, Inc.
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.
Advanced Breast Cancer, Metastatic Breast Cancer
A Study of SHR6390 Combined With Famitinib in the Treatment of HR + / HER2- Advanced Breast Cancer.
The study is being conducted to assess the efficacy and safety of SHR6390 combined with famitinib in the treatment of advanced or metastatic breast cancer that progress in 1-2 line endocrine therapy.
- Trial name
- NCT04733417
- Testing
- SHR6390, famitinib
- Where
- China
- Volunteers
- 35 people
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
Small Cell Lung Cancer
Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Combination With Etoposide and Carboplatin in Extensive Stage Small Cell Lung Cancer (SCLC)
This is a study to investigate the potential clinical benefit of trilaciclib (G1T28) in preserving the bone marrow and the immune system, and enhancing chemotherapy antitumor efficacy when administered prior to carboplatin and…
- Trial name
- NCT02499770
- Testing
- Carboplatin, Trilaciclib, Etoposide
- Where
- 40 sites in United States, France and 5 more
- Volunteers
- 122 people
- Sponsor
- G1 Therapeutics, Inc.
Hormone Receptor Positive Breast Cancer, Metastatic Breast Cancer
CDK4/6-inhibitor or Chemotherapy, in Combination with ENDOcrine Therapy, for Advanced Breast Cancer / KENDO
Prospective, open label, multicenter, group sequential response adaptive randomized phase 2 study, comparing two treatments for locally advanced or metastatic luminal breast cancer: Arm A: concomitant cyclin-dependent Kinase 4/6…
- Conditions
- Hormone Receptor Positive Breast Cancer, Metastatic Breast Cancer, Hormone Receptor Negative Breast Cancer
- Trial name
- KENDO (NCT03227328)
- Testing
- concomitant cyclin-dependent Kinase 4/6 (CDK4/6) inhibitor plus endocrine therapy, chemotherapy plus endocrine therapy (administered either concomitantly or sequentially)
- Where
- 20 sites in Italy
- Volunteers
- 52 people
- Sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Digestive System Tumors
A Trail of CDK4 / 6 Inhibitor and MEK Inhibitor in the Treatment of Metastatic Digestive System Tumors
This is a prospective, open, phase I clinical study to evaluate the safety and tolerability of a CDK4 / 6 inhibitor and a MEK inhibitor in the treatment of metastatic digestive system tumors
- Trial name
- NCT04615312
- Testing
- a CDK4 / 6 inhibitor and a MEK inhibitor
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Henan Cancer Hospital
Advanced Solid Tumor
A Study of CS3002 in Subjects With Advanced Solid Tumors
This is a phase I, open-label, multiple-dose, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of CS3002 in subjects with advanced solid tumors.
- Trial name
- NCT04162301
- Testing
- CS3002
- Where
- 2 sites in Australia
- Volunteers
- 10 people
- Sponsor
- CStone Pharmaceuticals
CDK4/6 Inhibitor, Breast Cancer
Pharmacogenomic and Circulating Biomarkers for CDK4/6 Inhibitors
The goal of this research study is to reduce adverse effects of anti-cancer medications known as kinase inhibitors, while preserving their therapeutic benefits. There have been major advances in the way cancers are treated.
- Conditions
- CDK4/6 Inhibitor, Breast Cancer, CYP3A4 Protein, Human, Drug Interaction
- Trial name
- NCT07100054
- Testing
- Whole gene sequencing, Drug-drug interaction analysis, Biomarker analysis
- Where
- Canada
- Volunteers
- 100 people
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Advanced Digestive System Neuroendocrine Neoplasm, Digestive System Neuroendocrine Tumor
Abemaciclib in Treating Patients With Advanced, Refractory, and Unresectable Digestive System Neuroendocrine Tumors
This phase II trial studies how well abemaciclib works in treating patients with digestive system neuroendocrine tumors that have spread to other places in the body, do not respond to treatment, and cannot be removed by surgery.
- Conditions
- Advanced Digestive System Neuroendocrine Neoplasm, Digestive System Neuroendocrine Tumor, Foregut Neuroendocrine Tumor, Hindgut Neuroendocrine Tumor
- Trial name
- NCT03891784
- Testing
- Abemaciclib
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- University of Washington
Breast Cancer Metastatic, Estrogen Receptor-positive Breast Cancer
Personalised Disease Monitoring in Metastatic Breast Cancer
Patients with metastatic breast cancer may respond well to treatment and metastases can remain stable for several years. Despite personalised medicine being increasingly used for diagnosis and treatment, follow-up still include…
- Trial name
- PDM-MBC (NCT04597580)
- Where
- 7 sites in Sweden, United Kingdom
- Volunteers
- 97 people
- Sponsor
- The Christie NHS Foundation Trust
Breast Cancer
AKT Inhibitor, Ipatasertib, With Endocrine and CDK 4/6 Inhibitor for Patients With Metastatic Breast Cancer (TAKTIC)
This study is exploring the safety/tolerabtility and preliminary efficacy of the combination of Ipatasertib with Aromatase inhibitor or Fulvestrant for patients with metastatic HR+ breast cancer.
- Trial name
- NCT03959891
- Testing
- Ipatasertib, Fulvestrant, Aromatase Inhibitor
- Where
- United States
- Volunteers
- 77 people
- Sponsor
- Massachusetts General Hospital
Breast Cancer
A Phase 2 Bridging Study of Elacestrant Monotherapy in Advanced or Metastatic Breast Cancer
This is a multicenter, open-label, Phase 2 bridging study to evaluate the efficacy and safety of elacestrant in Japanese post-menopausal women and men with estrogen receptor positive (ER+)/human epidermal growth factor receptor 2…
- Trial name
- NCT07766018
- Testing
- Elacestrant
- Where
- 19 sites in Japan
- Volunteers
- 70 people
- Sponsor
- Stemline Therapeutics, Inc.
Metastatic Breast Cancer, HER2 Low Breast Carcinoma
ERADICATE: A Phase Ib/II Study of Elacestrant Plus Trastuzumab Deruxtecan in Patients With CDK4/6 Inhibitor and Endocrine-resistant HR+/HER2-low or HER2-ultralow Metastatic Breast Cancer
The goal of this study is to evaluate the safety and efficacy of elacestrant in combination with trastuzumab deruxtecan (T-DXd) in participants with hormone receptor-positive (HR+), HER2-low or HER2-ultralow, metastatic breast…
- Conditions
- Metastatic Breast Cancer, HER2 Low Breast Carcinoma, HER2-negative Breast Cancer, Breast Cancer
- Trial name
- ERADICATE (NCT07198724)
- Testing
- Elacestrant, Trastuzumab Deruxtecan
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- Kristina A. Fanucci
Metastatic Breast Cancer
Efficacy Evaluation of Sabizabulin Monotherapy Versus Active Control for Treatment of ER+HER2- Metastatic Breast Cancer
To demonstrate the efficacy of sabizabulin in the treatment of ER+HER2- metastatic breast cancer (MBC) as measured by progression free survival (PFS) by RECIST v1.1.
- Trial name
- NCT05079360
- Testing
- Sabizabulin, Exemestane monotherapy, exemestane plus everolimus, or selective estrogen receptor modulator
- Where
- 26 sites in United States
- Sponsor
- Veru Inc.
Glioma
A Study Comparing Abemaciclib Plus Temozolomide to Temozolomide Monotherapy in Children and Young Adults With High-grade Glioma Following Radiotherapy
The purpose of this study is to measure the benefit of adding abemaciclib to the chemotherapy, temozolomide, for newly diagnosed high-grade glioma following radiotherapy.
- Trial name
- NCT06413706
- Testing
- Abemaciclib, Temozolomide
- Where
- 37 sites in United States, Australia and 8 more
- Volunteers
- 45 people
- Sponsor
- Eli Lilly and Company
Breast Cancer
Adjuvant Ribociclib With Endocrine Therapy in Hormone Receptor+/HER2- Intermediate Risk Early Breast Cancer
This is an international, multi-center, randomized, double-blinded, placebo-controlled clinical study evaluating the efficacy and safety of ribociclib with endocrine therapy as an adjuvant treatment in patients with hormone…
- Trial name
- EarLEE-2 (NCT03081234)
- Testing
- Ribociclib, Adjuvant endocrine therapy
- Sponsor
- Novartis Pharmaceuticals
ER-Positive HER2-Negative Breast Cancer
Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6)
The study is intended to show superiority of AZD9833 in combination with CDK4/6 inhibitor (palbociclib, abemaciclib or ribociclib) versus aromatase inhibitors (anastrozole or letrozole) in combination with CDK4/6 inhibitor in…
- Trial name
- SERENA-6 (NCT04964934)
- Testing
- AZD9833, Anastrozole, Letrozole
- Where
- 264 sites in United States, Australia and 21 more
- Volunteers
- 315 people
- Sponsor
- AstraZeneca