Clinical trials: Palbociclib
Breast Cancer
Study to Evaluate Overall Survival in Japanese Patients With HR+/HER2- Advanced Breast Cancer Treated With Palbociclib Plus Letrozole
This is a retrospective, multicenter, observational study in Japan. The primary objective is to evaluate overall survival (OS) in Japanese patients with HR+/HER2- advanced breast cancer who have been treated with palbociclib plus…
- Trial name
- NCT04735367
- Testing
- palbociclib plus letrozole
- Where
- 13 sites in Japan
- Volunteers
- 42 people
- Sponsor
- Pfizer
Sarcoma, Liposarcoma
PD0332991 (Palbociclib) in Patients With Advanced or Metastatic Liposarcoma
The purpose of this study is to find out what effects, good and/or bad, Palbociclib (Ibrance) (formerly known as PD0332991) has on the patient and on the liposarcoma. Palbociclib is an investigational drug.
- Trial name
- NCT01209598
- Testing
- Palbociclib 200mg, Palbociclib 125mg
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Breast Cancer
A Phase 1/2 Trial of ARV-471 Alone and in Combination With Palbociclib (IBRANCE®) in Participants With ER+/HER2- Locally Advanced or Metastatic Breast Cancer
This was a Phase 1/2 dose escalation and cohort expansion study and assessed the safety, tolerability and anti-tumor activity of ARV-471 alone and in combination with palbociclib (IBRANCE®) in participants with estrogen receptor…
- Trial name
- mBC (NCT04072952)
- Testing
- Vepdegestrant, Palbociclib
- Where
- 16 sites in United States
- Volunteers
- 219 people
- Sponsor
- Arvinas Estrogen Receptor, Inc.
Metastatic Breast Carcinoma, Stage IV Breast Cancer AJCC v6 and v7
Pembrolizumab, Endocrine Therapy, and Palbociclib in Treating Postmenopausal Patients With Newly Diagnosed Metastatic Stage IV Estrogen Receptor Positive Breast Cancer
This phase II trial studies how well pembrolizumab works when given together with endocrine therapy and palbociclib in treating postmenopausal patients with newly diagnosed stage IV estrogen receptor positive breast cancer that…
- Trial name
- NCT02778685
- Testing
- Fulvestrant, Laboratory Biomarker Analysis, Letrozole
- Where
- 7 sites in United States
- Volunteers
- 47 people
- Sponsor
- City of Hope Medical Center
Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, Hormone Receptor (HR)-Positive Breast Cancer
Palbociclib With Everolimus + Exemestane In BC
This research study is studying a combination of targeted therapy and hormonal therapy as a possible treatment for breast cancer that has spread to other places in the body and is hormone receptor positive (HR+) and…
- Trial name
- NCT02871791
- Testing
- Palbociclib, Everolimus, Exemestane
- Where
- United States
- Volunteers
- 41 people
- Sponsor
- Dana-Farber Cancer Institute
Glioblastoma, Gliosarcoma
A Study of PD 0332991 in Patients With Recurrent Rb Positive Glioblastoma
This study will determine the efficacy of the small molecule CDK4/6 inhibitor PD 0332991 (as measured by progression free survival at 6 months) in patients with recurrent glioblastoma multiforme or gliosarcoma who are Rb…
- Conditions
- Glioblastoma, Gliosarcoma, Anaplastic Astrocytoma
- Trial name
- PD0332991 (NCT01227434)
- Testing
- PD 0332991 (pre-surgery), PD 0332991, Resection as clinical care
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- University of California, San Francisco
Breast Cancer
RW Treatment Patterns and Outcomes in Postmenopausal HR+/HER2- mBC Patients Treated With Palbociclib Plus Letrozole as Initial Endocrine Therapy at Community Oncology Practices in the U.S.
This is a retrospective, observational study that will document treatment patterns and clinical outcomes of postmenopausal patients diagnosed with HR+/HER2- mBC who received Palbociclib plus Letrozole as initial endocrine-based…
- Trial name
- NCT04460898
- Where
- United States
- Volunteers
- 195 people
- Sponsor
- Pfizer
Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma
Aromatase Inhibitor Therapy With or Without Fulvestrant for the Treatment of HR Positive Metastatic Breast Cancer With an ERS1 Activating Mutation, the INTERACT Study
This phase II trial studies how well letrozole, anastrozole, or fulvestrant work when given together with ribociclib, palbociclib, and/or abemaciclib in treating patients with hormone receptor (HR) positive breast cancer that has…
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Prognostic Stage IV Breast Cancer AJCC v8
- Trial name
- NCT04256941
- Testing
- Abemaciclib, Anastrozole, Fulvestrant
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- M.D. Anderson Cancer Center
Advanced Breast Cancer Female
Palbociclib Plus Letrozole For Postmenopausal Women With HR(+) HER2(-) Advanced Breast Cancer For Whom Letrozole Is Deemed Appropriate
The purpose of this study is to provide access to palbociclib in Mexico and in selected Latin American countries before it becomes commercially available to patients with HR positive/HER2-negative ABC who are appropriate…
- Trial name
- NCT02600923
- Testing
- Palbociclib, Letrozole
- Where
- 24 sites in Argentina, Brazil and 2 more
- Volunteers
- 131 people
- Sponsor
- Pfizer
Breast Cancer
Real-world Treatment Patterns of Endocrine Based Therapy Among Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor-2-negative (HR+/HER2-) Advanced Breast Cancer: An Analysis of Administrative Claims Data in Japan
This is a retrospective observational study focusing on patients diagnosed with advanced breast cancer(ABC) in Japan using de-identified claim data from Medical Data Vision (MDV) database.
- Trial name
- NCT05153187
- Where
- Japan
- Volunteers
- 1,170 people
- Sponsor
- Pfizer
Breast Cancer
Two Different Schedules of Palbociclib + Second Line Endocrine Therapy in Estrogen Receptor Positive, HER2 Neg Advanced/Metastatic Breast Cancer
The purpose of this study is to determine if the combination of endocrine therapy and Palbociclib at a daily dose of 100 mg will result in a better response to therapy with fewer dose interruptions than the proposed dosing…
- Trial name
- NCT02630693
- Testing
- Palbociclib 100mg, Palbociclib 125mg, Fulvestrant or Tamoxifen or Aromatase Inhibitor
- Where
- 22 sites in Canada
- Volunteers
- 180 people
- Sponsor
- Canadian Cancer Trials Group
Metastatic Urothelial Carcinoma (UC)
Phase II Trial of Palbociclib in Patients With Metastatic Urothelial Cancer After Failure of First-Line Chemotherapy
This multicenter phase II trial will evaluate palbociclib (PD-0332991) in patients with metastatic urothelial carcinoma (UC) with cyclin-dependent kinase inhibitor 2A (CDKN2A) (also referred to as p16) loss and positive…
- Trial name
- NCT02334527
- Testing
- Palbociclib
- Where
- 3 sites in United States
- Volunteers
- 12 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
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
Metastatic Breast Cancer
Palbociclib After CDK and Endocrine Therapy (PACE)
This research study is studying three combinations of drugs as treatments for breast cancer. The drugs involved in this study are: Fulvestrant Fulvestrant with Palbociclib Fulvestrant with Palbociclib and Avelumab
- Trial name
- NCT03147287
- Testing
- Palbociclib, Fulvestrant, Avelumab
- Where
- 22 sites in United States
- Volunteers
- 220 people
- Sponsor
- Dana-Farber Cancer Institute
Metastatic Breast Cancer
Real-World Effectiveness of Palbociclib in Combination With an Aromatase Inhibitor
A retrospective study of de-identified (to preserve patient privacy) patient information from the Flatiron Health Analytic Database to compare effectiveness (i.e., overall survival) of first line palbociclib + aromatase inhibitor…
- Trial name
- NCT05361655
- Testing
- Palbociclib + an aromatase inhibitor, Aromatase inhibitor
- Where
- United States
- Volunteers
- 2,888 people
- Sponsor
- Pfizer
Anatomic Stage IV Breast Cancer AJCC v8, Estrogen Receptor Positive
Radiation Therapy, Palbociclib, and Hormone Therapy in Treating Breast Cancer Patients With Bone Metastasis
This phase II trial studies how well radiation therapy given with standard care palbociclib and hormone therapy work in treating patients with breast cancer that has spread from one part of the body to the bone.
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, Estrogen Receptor Positive, HER2/Neu Negative, Metastatic Breast Carcinoma
- Trial name
- ASPIRE (NCT03691493)
- Testing
- Anastrozole, Exemestane, Fulvestrant
- Where
- 10 sites in United States
- Volunteers
- 36 people
- Sponsor
- Emory University
Breast Cancer
Study to Evaluate Patient Reported Outcome (PRO) and Physical Activity in Japanese Patients With HR+/HER2- Advanced Breast Cancer Treated With Palbociclib Plus Endocrine Therapy or Endocrine Monotherapy
The study is a prospective, multicenter, observational study to evaluate PRO and physical activity using smartphone-based application and wearable device in Japanese patients with HR+/HER2- advanced breast cancer (ABC).
- Trial name
- JBCRG-26 (NCT04736576)
- Testing
- Wearable device
- Where
- 20 sites in Japan
- Volunteers
- 99 people
- Sponsor
- Pfizer
Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Safety And Efficacy Study Of Palbociclib Plus Cetuximab Versus Cetuximab To Treat Head And Neck Cancer
The purpose of this study is to determine whether the combination of palbociclib with cetuximab is superior to cetuximab in prolonging overall survival in HPV-negative, cetuximab-naive patients with recurrent/metastatic squamous…
- Trial name
- NCT02499120
- Testing
- palbociclib, Cetuximab
- Where
- 71 sites in United States, Czechia and 13 more
- Volunteers
- 125 people
- Sponsor
- Pfizer
Non-small Cell Lung Cancer Metastatic, Non-small Cell Lung Cancer Stage IIIB
Survival Prolongation by Rationale Innovative Genomics
Patients with advanced/metastatic non-small cell lung cancer (NSCLC) with no documented targetable alterations (Epidermal Growth Factor Receptor (EGFR) mutation, Anaplastic Lymphoma Kinase (ALK) translocation, ROS1 mutation if…
- Trial name
- SPRING (NCT03386929)
- Testing
- Avelumab, Axitinib, Palbociclib
- Where
- 5 sites in United States, Israel and 2 more
- Volunteers
- 15 people
- Sponsor
- Worldwide Innovative Network Association
Breast Cancer
Amcenestrant (SAR439859) Plus Palbociclib as First Line Therapy for Patients With ER (+) HER2(-) Advanced Breast Cancer
Primary Objective: To determine whether Amcenestrant (SAR439859) in combination with palbociclib improves progression free survival (PFS) when compared with letrozole in combination with palbociclib in participants with estrogen…
- Trial name
- AMEERA-5 (NCT04478266)
- Testing
- SAR439859, Palbociclib, Letrozole
- Where
- 249 sites in United States, Argentina and 28 more
- Volunteers
- 1,068 people
- Sponsor
- Sanofi