Clinical trials: Palbociclib
Advanced Breast Carcinoma, Locally Advanced Breast Carcinoma
Genetic Analysis in Blood and Tumor Samples From Patients With Advanced or Metastatic Estrogen Receptor Positive and HER2 Negative Breast Cancer Receiving Palbociclib and Endocrine Therapy
This research trial studies genetic profiles in blood and tumor samples from patients with estrogen receptor positive and HER2 negative breast cancer that has spread to other places in the body who are receiving palbociclib and…
- Conditions
- Advanced Breast Carcinoma, Locally Advanced Breast Carcinoma, Metastatic Breast Carcinoma, Recurrent Breast Carcinoma
- Trial name
- NCT03281902
- Testing
- Biopsy, Biospecimen Collection, Laboratory Biomarker Analysis
- Where
- 3 sites in United States
- Volunteers
- 68 people
- Sponsor
- Mayo Clinic
Breast Cancer, Solid Tumor, Adult
A Study to Investigate the Safety, Tolerability, of APG-2575 as a Single Agent or in Combination for Breast Cancer
This is a multi-center, open-label, phase Ib/II study of APG-2575 as a single agent in patients with advanced solid tumors or in combination with anti-cancer agents such as CDK 4/6 inhibitor palbociclib in patients with ER+/HER2…
- Trial name
- NCT04946864
- Testing
- APG-2575, Palbociclib
- Where
- 7 sites in United States, China
- Volunteers
- 65 people
- Sponsor
- Ascentage Pharma Group Inc.
Breast Cancer, Brain Metastases
Palbociclib, Trastuzumab,Pyrotinib and Fulvestrant Treatment in Patients With Brain Metastasis From ER/PR Positive, HER-2 Positive Breast Cancer: A Multi-center, Prospective Study in China
The objective of this study is to evaluate the efficacy of combination of palbociclib, trastuzumab and pyrotinib with fulvestrant in ER/PR positive and HER2-positive breast cancer patients with brain metastasis.
- Trial name
- NCT04334330
- Testing
- Palbociclib, Trastuzumab, Pyrotinib and Fulvestrant
- Where
- 2 sites in China
- Volunteers
- 34 people
- Sponsor
- Sun Yat-sen University
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
HR+ HER2- Breast Cancer
Sapanisertib and Serabelisib (PIKTOR) in Various Combinations in Patients With HR+/HER2- Advanced/Metastatic Breast Cancer
The study is a Phase 1b/2, multi-center, open-label, dose escalation trial evaluating the safety and preliminary efficacy of sapanisertib and serabelisib (PIKTOR) with fulvestrant and/or other anticancer therapies in participants…
- Trial name
- NCT07558733
- Testing
- Serabelisib, Sapanisertib, Fulvestrant
- Where
- 7 sites in United States
- Volunteers
- 32 people
- Sponsor
- Faeth Therapeutics
Neoplasms, Breast Neoplasms
A Study Of Oral Palbociclib (PD-0332991), A CDK4/6 Inhibitor, As Single Agent In Japanese Patients With Advanced Solid Tumors Or In Combination With Letrozole For The First-Line Treatment Of Postmenopausal Japanese Patients With ER (+) HER2 (-) Advanced Breast Cancer
This study is comprised of two portions: a Phase 1 portion and a Phase 2 portion. The Phase 1 portion is a single-country, non-randomized, open label, clinical trial which will evaluate the safety, tolerability, preliminary…
- Trial name
- NCT01684215
- Testing
- PD-0332991, letrozole
- Where
- 16 sites in Japan
- Volunteers
- 61 people
- Sponsor
- Pfizer
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
Breast Neoplasm
Impact of eHealth-support on Quality of Life in Metastatic Breast Cancer Patients Treated With Palbociclib and Endocrine Therapy
In this study the investigators assess the impact of the eHealth-supported therapy management system CANKADO on Quality of Life in patients with HR+, HER2-locally advanced or metastatic breast cancer treated with the cyclin…
- Trial name
- PRECYCLE (NCT03220178)
- Testing
- Palbociclib, Fulvestrant, Anastrozole
- Where
- Germany
- Volunteers
- 532 people
- Sponsor
- Palleos Healthcare GmbH
Rare Tumor
PLATFORM Study of Precision Medicine for Rare Tumors
A Phase II, open label, non-randomized, multiple-arm, single-center clinical trial in patients with advanced rare solid tumors who failed to standard treatment.
- Trial name
- NCT04423185
- Testing
- Almonertinib 110 MG, Dacomitinib 45 MG, Alectinib 150 MG
- Where
- China
- Volunteers
- 770 people
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Salivary Gland Carcinoma, Precision Therapy
Precision Treatment of Recurrent/Metastatic Salivary Gland Carcinoma Guided by Molecular Typing
Patients with salivary gland carcinoma were divided into groups according to HER2, NTRK, AR, TROP-2, etc. Patients in different groups were given precision targeted therapy or chemotherapy to evaluate the efficacy (ORR rate) and…
- Trial name
- NCT06145308
- Testing
- Cohort 1 (HER2-positive, RC48-ADC), Cohort 2 (NTRK-fusion or NTRK-mutant), Cohort 3 (AR-positive, leuprolide + bicalutamide + abiraterone)
- Where
- 2 sites in China
- Volunteers
- 39 people
- Sponsor
- Peking Union Medical College
Metastatic Breast Cancer, Advanced Breast Cancer
Patterns of Prescribing and Monitoring of Palbociclib
The purpose of this study is to determine if patients with ER+, human epidermal growth factor 2 negative (HER2-), advanced breast cancer are receiving dosing adjustments and monitoring based on manufacturer recommendations at a…
- Conditions
- Metastatic Breast Cancer, Advanced Breast Cancer, Estrogen Receptor-positive Breast Cancer, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
- Trial name
- NCT03285568
- Testing
- Palbociclib
- Volunteers
- 67 people
- Sponsor
- Rush University Medical Center
Metastatic Breast Cancer, Advanced Breast Cancer
Implementing Geriatric Assessment for Dose Optimization of Cyclin-dependent Kinase (CDK) 4/6-inhibitors in Older Breast Cancer Patients
IMPORTANT study is a multicenter, open-label, prospective, randomized-controlled, non-inferiority trial with a pragmatic approach involving older patients (≥ 70 years old) with advanced hormone receptor (HR)-positive/human…
- Conditions
- Metastatic Breast Cancer, Advanced Breast Cancer, Quality of Life, Toxicity
- Trial name
- IMPORTANT (NCT06044623)
- Testing
- CDK 4/6 inhibitors, Endocrine therapy
- Where
- 12 sites in Finland, Greece and 4 more
- Volunteers
- 495 people
- Sponsor
- Region Örebro County
Breast Cancer
Treatment Landscape and Real-World Dosing Patterns With CDK4/6 Inhibitors for Breast Cancer in Portugal
Assess and characterize the real-world cyclin-dependent kinase 4/6 inhibitor (CDKI) use in advanced/metastatic breast cancer (a/mBC), evaluate treatment persistence, and quantify CDKI dose adjustments in Portugal.
- Trial name
- PORTRAIT (NCT07223476)
- Where
- United States
- Volunteers
- 1,926 people
- Sponsor
- Novartis Pharmaceuticals
Rare Tumour
Study of Precision Treatment for Rare Tumours in China Guided by PDO and NGS
The objective of this Phase II, open-label, multicenter, non-randomised controlled clinical trial is to guide precision treatment for patients with rare tumours based on Patient-Derived Organoids/Next-Generation Sequencing drug…
- Trial name
- SPRING (NCT06692491)
- Testing
- Albumin-Bound Paclitaxel, Epirubicin, Gemcitabine
- Volunteers
- 200 people
- Sponsor
- Peking University Shenzhen Hospital
Breast Cancer Stage IV
The Resistance and Immune Response to Palbociclib in Breast Cancer
The investigators propose to conduct a biomarker and molecular profiling study in longitudinally paired tumor biopsies and serum from patients with Hormone Receptor positive (HR+) metastatic Breast Cancer (BC) treated with…
- Trial name
- NCT03401359
- Testing
- tissue biopsy, blood sample
- Where
- South Korea
- Volunteers
- 100 people
- Sponsor
- Samsung Medical Center
Healthy
A Single-Radiolabeled Dose Mass Balance Study To Investigate The Absorption, Metabolism, And Excretion Of [14C] Palbociclib (PD-0332991) In Healthy Male Volunteers
This will be an open-label, single-center study to evaluate the mass-balance and pharmacokinetics of PD-0332991 in approximately 6 healthy male subjects receiving a single oral 125 mg dose of PD-0332991 containing approximately…
- Trial name
- NCT01756768
- Testing
- [14C]-PD-0332991
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Pfizer
Renal Cell Carcinoma, Ovarian Carcinoma
OPTI - DOSE: Optimal Dosing of Oral Anticancer Drugs in Older Adults
The study hypothesis is that a lower starting dose of anticancer tablet treatments can lead to better treatment tolerability in older patients, while the benefits of treatment can be the same.
- Conditions
- Renal Cell Carcinoma, Ovarian Carcinoma, Thyroid Carcinoma, Breast Carcinoma
- Trial name
- OPTI-DOSE (NCT05949424)
- Testing
- Olaparib, Lenvatinib, Sunitinib
- Where
- Netherlands
- Volunteers
- 30 people
- Sponsor
- University Medical Center Groningen
Breast Cancer
Validation of Capillary Microsampling for Therapeutic Drug Monitoring of CDK4/6 Inhibitors in Breast Cancer Patients (TDHOME)
This is a prospective validation study, multicenter, open-label, single-arm study, evaluating the concordance between capillary microsampling (using the VAMS Mitra device) and venous sampling in patients undergoing CDK4/6 therapy.
- Trial name
- TDHOME (NCT07491380)
- Testing
- Capillary samples using the VAMS Mitra device
- Where
- 2 sites in France
- Volunteers
- 90 people
- Sponsor
- Institut Curie
Inhibition of Autophagy Synergizes Anti-tumor Effect
A Phase Ib/II Study Confirmed Inhibition of Autophagy Synergizes Anti-tumor Effect of High Dose CDK4/6i
In order to explore the safety and antitumor efficacy of different doses of CDK4/6 inhibitor Palbociclib in combination with the autophagy inhibitor hydroxychloroquine (HCQ) , a phase Ib/II study was conducted.
- Trial name
- NCT05953350
- Testing
- 600mg bid dose of hydroxychloroquine combined with three predefined dose groups of palbociclib, RP2D dose of 600mg bid of hydroxychloroquine combined with palbociclib was selected for phase II clinical trial.
- Where
- China
- Volunteers
- 29 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Breast Cancer
Phase 1b/2 Study of TTI-101 in Combination for Patients With Metastatic Hormone Receptor-Positive and HER2-Negative Breast Cancer
The primary objective of Phase 1b will be to evaluate the safety and tolerability of TTI-101 when added to palbociclib and AI or fulvestrant administered orally to participants with hormone receptor-positive (HR+) human epidermal…
- Trial name
- NCT05384119
- Testing
- TTI-101, Palbociclib, Aromatase inhibitor (AI)
- Where
- 6 sites in United States
- Volunteers
- 6 people
- Sponsor
- Tvardi Therapeutics, Incorporated