Clinical trials: CDK4/6 Inhibitor
Advanced Breast Cancer
Genetically-informed Therapy for ER+ Breast Cancer Post-CDK4/6 Inhibitor
The purpose of this study is to learn if certain drug combinations are effective treatments for patients with advanced ER+/HER2- who have previously been treated with palbociclib, ribociclib, or abemaciclib.
- Trial name
- GERTRUDE (NCT05933395)
- Testing
- Fulvestrant, Neratinib, Alpelisib
- Where
- United States
- Volunteers
- 135 people
- Sponsor
- Dartmouth-Hitchcock Medical Center
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
EGFR Tyrosine Kinase Inhibitors Plus Cyclin-dependent Kinase 4/6 Inhibitor
A Study of Almonertinib Combined With Palbociclib in Patients With Advanced Solid Tumors Harboring KRAS Mutations
The main purpose of this study is to evaluate the safety and tolerability of almonertinib combined with palbociclib in patients with advanced solid tumors harboring KRAS gene mutations, and to conduct a preliminary observation of…
- Trial name
- APEAK (NCT06947811)
- Testing
- Almonertinib, Palbociclib
- Where
- China
- Volunteers
- 71 people
- Sponsor
- Sun Yat-sen 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.
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
Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm
Ribociclib and Gemcitabine Hydrochloride in Treating Patients With Advanced or Metastatic Solid Tumors
This phase I trial studies the side effects and best dose of ribociclib and gemcitabine hydrochloride in treating patients with solid tumors that have spread to other places in the body.
- Trial name
- NCT03237390
- Testing
- Gemcitabine Hydrochloride, Laboratory Biomarker Analysis, Pharmacological Study
- Where
- 3 sites in United States
- Volunteers
- 43 people
- Sponsor
- Mayo Clinic
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
HR+/HER2- Advanced/Metastatic Breast Cancer
Sirolimus for Injection (Albumin-bound) Combined With Fulvestrant for HR+/HER2- Advanced/Metastatic Breast Cancer Patients Previously Treated With CDK4/6 Inhibitors
A randomized, double-blind, multicenter phase III clinical study to evaluate the efficacy and safety of sirolimus for injection (albumin-bound) combined with fulvestrant in patients with HR+ and HER2- advanced breast cancer.
- Trial name
- NCT06929325
- Testing
- Sirolimus for Injection (Albumin-bound), Fulvestrant Injection
- Where
- China
- Volunteers
- 312 people
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma
A Study of a New Drug Combination, Copanlisib and Fulvestrant, in Advanced Breast Cancer
This phase I/II trial studies the side effects and how well copanlisib works when given together with fulvestrant in treating patients with estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative…
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Metastatic Malignant Neoplasm in the Brain, Prognostic Stage IV Breast Cancer AJCC v8
- Trial name
- NCT03803761
- Testing
- Copanlisib, Fulvestrant
- Where
- 7 sites in United States
- Sponsor
- National Cancer Institute (NCI)
Breast Cancer Female
PreOperative Endocrine Therapy for Individualised Care With Abemaciclib
POETIC-A is a phase 3 trial which targets post-menopausal primary breast cancer patients with a high 5-year risk of relapse as determined by a high Ki67 after 2 weeks aromatase inhibitor therapy pre-surgery.
- Trial name
- POETIC-A (NCT04584853)
- Testing
- Abemaciclib, Endocrine therapy (letrozole, anastrozole, exemestane or tamoxifen)
- Where
- 62 sites in United Kingdom
- Volunteers
- 123 people
- Sponsor
- Institute of Cancer Research, United Kingdom
Breast Cancer
Fulvestrant and Ipatasertib for Advanced HER-2 Negative and Estrogen Receptor Positive (ER+) Breast Cancer Following Progression on First Line CDK 4/6 Inhibitor and Aromatase Inhibitor
The purpose of this study is to find out whether a new drug, Ipatasertib, can slow the growth of advanced breast cancer when added to standard therapy (Fulvestrant).
- Trial name
- FINER (NCT04650581)
- Testing
- Ipatasertib, Fulvestrant
- Where
- 39 sites in Australia, Canada and 1 more
- Volunteers
- 250 people
- Sponsor
- Canadian Cancer Trials Group
Metastatic Breast Cancer (MBC), HER2-Positive Breast Cancer
Trastuzumab Rezetecan Followed by Pyrotinib, Fulvestrant, and Dalpiciclib in HR-Positive, HER2-Positive Advanced Breast Cancer
The purpose of this clinical trial is to evaluate whether, in patients with hormone receptor-positive (HR-positive) and HER2-positive advanced breast cancer whose disease has progressed after trastuzumab-based therapy, switching…
- Conditions
- Metastatic Breast Cancer (MBC), HER2-Positive Breast Cancer, Hormone Receptor-Positive Breast Cancer
- Trial name
- NCT07892274
- Testing
- Fulvestrant, Pyrotinib, Dalpiciclib
- Where
- China
- Volunteers
- 226 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Breast Neoplasm Female
Endocrine Therapy Plus CDK4/6 in First or Second Line for Hormone (SONIA) Receptor Positive Advanced Breast Cancer
Given the uncertain benefit in efficacy of adding CDK 4/6 to first rather than second line endocrine treatment, the aim of this project is to evaluate whether the sequence of an aromatase inhibitor plus CDK 4/6 in first line…
- Trial name
- NCT03425838
- Testing
- CDK 4/6 inhibitor, Non-Steroidal Aromatase Inhibitor, Fulvestrant
- Where
- 72 sites in Netherlands
- Volunteers
- 1,050 people
- Sponsor
- Borstkanker Onderzoek Groep
HR+ HER2- Metastatic Breast Cancer, Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, Triple Negative Breast Cancer, Male Breast Cancer
A Study of PF-06873600 in People With Cancer
The purpose of this clinical trial is to learn about the safety and effects of study medicine (PF-06873600) when taken alone or with hormone therapy by people with cancer.
- Trial name
- NCT03519178
- Testing
- PF-06873600, Endocrine Therapy 1, Endocrine Therapy 2
- Where
- 54 sites in United States, Bulgaria and 4 more
- Volunteers
- 155 people
- Sponsor
- Pfizer
Non-small Cell Lung Cancer
Cyclin Dependent Kinase (CDK)4/6 Inhibitor, PD0332991 in Advanced Non-small Cell Lung Cancer NSCLC.
The purpose of this study is to determine the efficacy and the toxicities of the study drug PD0332991 in the treatment of patients with Stage IV non-small cell lung cancer with wildtype retinoblastoma protein (RB) and inactivated…
- Trial name
- NCT01291017
- Testing
- PD0332991
- Where
- 2 sites in United States
- Volunteers
- 19 people
- Sponsor
- University of Florida
Breast Cancer Metastatic
Clinical Trial of Avasopasem in Patients With Metastatic Hormone Receptor Positive Breast Cancer With Progression on a CDK 4/6 Inhibitor and Hormonal Therapy
This study aims to evaluate the safety of avasopasem in combination with CDK 4/6 inhibitor and hormonal therapy in women with metastatic hormone receptor positive breast cancer, and to see if the addition of avasopasem improves…
- Trial name
- NCT07137871
- Testing
- Avasopasem
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- The University of Texas Health Science Center at San Antonio
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
Recurrent Ovarian Carcinoma
Dalpiciclib Combined With Letrozole in HR+/HER2 - Gynecologic Solid Tumors
This is a prospective, single-arm, single-center registry study to investigate 6-month progression-free survival with Dalpiciclib, a CDK4/6 kinase inhibitor, plus letrozole in patients with unresectable refractory or resistant…
- Trial name
- NCT06243185
- Testing
- Dalpiciclib plus letrozole
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Fengzhi Feng
Breast Cancer
A Real-World Study of Early Breast Cancer Patients Eligible for Treatment With CDK4/6 Inhibitors
The aim of this study was to describe treatment patterns, patient characteristics and clinical outcomes among hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) early breast cancer (eBC)…
- Trial name
- LEEWARD (NCT07647042)
- Where
- United States
- Volunteers
- 750 people
- Sponsor
- Novartis Pharmaceuticals