Clinical trials: Palbociclib
Metastatic Breast Cancer
Ribociclib vs. Palbociclib in Patients With Advanced Breast Cancer Within the HER2-Enriched Intrinsic Subtype
HARMONIA is an international, multicenter, randomized, open-label and phase III study. The primary objective of this study is to demonstrate that the combination of ribociclib with endocrine therapy (letrozole or fulvestrant) is…
- Trial name
- HARMONIA (NCT05207709)
- Testing
- Ribociclib + Letrozole OR Fulvestrant, Palbociclib + Letrozole OR Fulvestrant, Paclitaxel +/- Tislelizumab
- Where
- 71 sites in United States, Portugal and 1 more
- Volunteers
- 61 people
- Sponsor
- SOLTI Breast Cancer Research Group
Breast Cancer
Palbociclib and Endocrine Therapy for LObular Breast Cancer Preoperative Study (PELOPS)
This research study is evaluating how well Breast Cancer responds to preoperative treatment with Endocrine treatment in combination with a drug called Palbociclib or Endocrine treatment alone as possible treatments for Hormone…
- Trial name
- NCT02764541
- Testing
- Letrozole, Tamoxifen, Palbociclib
- Where
- 11 sites in United States
- Volunteers
- 195 people
- Sponsor
- Dana-Farber Cancer Institute
Breast Cancer
PALbociclib CoLlaborative Adjuvant Study
This is a prospective, two arm, international, multicenter, randomized, open-label Phase III study evaluating the addition of 2 years of palbociclib to standard adjuvant endocrine therapy for patients with HR+ / HER2- early…
- Trial name
- PALLAS (NCT02513394)
- Testing
- Palbociclib, Standard Adjuvant Endocrine Therapy
- Where
- 437 sites in United States, Australia and 19 more
- Volunteers
- 5,796 people
- Sponsor
- Alliance Foundation Trials, LLC.
Breast Cancer, Metastatic Breast Cancer
Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer
This is a multicenter, Phase 1b/2 trial in participants with estrogen receptor positive/human epidermal growth factor receptor 2 negative (ER+/HER2-) advanced/metastatic breast cancer.
- Trial name
- ELEVATE (NCT05563220)
- Testing
- Elacestrant, Alpelisib, Everolimus
- Where
- 83 sites in United States, Argentina and 11 more
- Volunteers
- 435 people
- Sponsor
- Stemline Therapeutics, Inc.
Metastatic Breast Cancer
Palbociclib With Fulvestrant for Metastatic Breast Cancer After Treatment With Palbociclib and an Aromatase Inhibitor
This study is being done to look at the role of continuing palbociclib treatment in combination with another type of hormonal therapy (fulvestrant) after disease progression of palbociclib in combination with an aromatase…
- Trial name
- NCT02738866
- Testing
- Palbociclib, Fulvestrant
- Where
- 5 sites in United States
- Volunteers
- 60 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Hormone Receptor-positive Breast Cancer, HER2-negative Breast Cancer
ONO-4578-06:Phase I Study of ONO-4578 and Letrozole Plus CDK4 /6 Inhibitors in Breast Cancer
This is a multicenter, open-label, non-controlled, phase I study to investigate the tolerability and safety of ONO-4578 used in combination with standard-of-care letrozole and a CDK4/6 inhibitor (palbociclib or Abemaciclib) as…
- Conditions
- Hormone Receptor-positive Breast Cancer, HER2-negative Breast Cancer, Metastatic Breast Cancer, Recurrent Breast Cancer
- Trial name
- NCT06570031
- Testing
- ONO-4578, letrozole, Palbociclib
- Where
- 13 sites in Japan
- Volunteers
- 46 people
- Sponsor
- Ono Pharmaceutical Co., Ltd.
Breast Neoplasms
Treatment Patterns and Clinical Outcomes Among Patients Receiving Palbociclib Combinations for Hormone Receptor Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2 ) Advanced/Metastatic Breast Cancer in the Arabian Gulf Region
retrospective non-interventional study (NIS) that aims to describe the demographics, clinical characteristics, clinical outcomes, and treatment patterns, among patients receiving palbociclib for the treatment of HR+/HER2…
- Trial name
- NCT04916509
- Testing
- Palbociclib plus an aromatase inhibitor, Palbociclib plus fulvestrant
- Where
- 7 sites in Qatar, Saudi Arabia and 1 more
- Volunteers
- 258 people
- Sponsor
- Pfizer
Recurrent Mantle Cell Lymphoma
Ibrutinib and Palbociclib in Treating Patients With Previously Treated Mantle Cell Lymphoma
This phase I trial studies the side effects and best dose of ibrutinib and palbociclib in treating patients with previously treated mantle cell lymphoma.
- Trial name
- NCT02159755
- Testing
- Ibrutinib, Laboratory Biomarker Analysis, Palbociclib
- Where
- 4 sites in United States
- Volunteers
- 28 people
- Sponsor
- National Cancer Institute (NCI)
Sarcoma
Palbociclib and Pembrolizumab in Sarcoma
This is a single-arm open-label window of opportunity clinical study assessing the impact of pre-treatment with palbociclib in patients with soft tissue sarcomas for which PD-1 inhibitors are approved (includes undifferentiated…
- Trial name
- NCT06113809
- Testing
- Palbociclib, Pembrolizumab
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- John Rieth
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
Breast Cancer Stage IV, Radiotherapy
Locoregional Treatment and Palbociclib in de Novo, Treatment Naive, Stage IV ER+, HER2- Breast Cancer Patients
Approximately 3.5% to 6% of newly diagnosed breast cancer patients are stage IV metastatic. De novo metastatic breast cancer accounts for 20% to 25% of these cases.
- Conditions
- Breast Cancer Stage IV, Radiotherapy, Surgery
- Trial name
- PALATINE (NCT03870919)
- Testing
- Palbociclib, locoregional treatment
- Where
- 26 sites in France
- Volunteers
- 200 people
- Sponsor
- UNICANCER
Breast Neoplasms
A Study Of Palbociclib (PD-0332991) + Letrozole VS. Placebo+ Letrozole For 1st Line Treatment Of Asian Postmenopausal Women With ER+/HER2- Advanced Breast Cancer [PALOMA-4]
The study is designed to compare the clinical benefit following treatment with letrozole in combination with Palbociclib versus letrozole in combination with placebo in Asian postmenopausal women with ER(+)/HER2(-) advanced…
- Trial name
- NCT02297438
- Testing
- Palbociclib, Letrozole
- Where
- 54 sites in China, Hong Kong and 3 more
- Volunteers
- 340 people
- Sponsor
- Pfizer
Breast Cancer Stage II, Breast Cancer Stage III
Adjuvant Palbociclib in Elderly Patients With Breast Cancer
Phase II study to assess the efficacy of the combination of at least 5 year endocrine therapy and 2 year-palbociclib as adjuvant systemic treatment instead of adjuvant chemotherapy followed by endocrine therapy in older patients…
- Trial name
- Appalaches (NCT03609047)
- Testing
- Palbociclib, Docetaxel / cyclophosphamide, doxorubicin/cyclophosphamide
- Where
- 73 sites in Belgium, France and 7 more
- Volunteers
- 366 people
- Sponsor
- European Organisation for Research and Treatment of Cancer - EORTC
Advanced Breast Cancer
Emulation of the PALOMA-2 Trial
Investigators are building an empirical evidence base for real world data through large-scale emulation of randomized controlled trials.
- Trial name
- NCT07178743
- Testing
- Initiation of palbociclib plus letrozole, Initiation of letrozole
- Where
- United States
- Volunteers
- 6,097 people
- Sponsor
- Brigham and Women's Hospital
Small Cell Lung Cancer, Ovarian Cancer
PF-07104091 as a Single Agent and in Combination Therapy
To assess the safety and tolerability of increasing doses of PF-07104091 and to estimate the Maximum Tolerated Dose (MTD) and/or select the Recommended Phase 2 dose (RP2D) for PF-07104091 as a single agent in participants with…
- Conditions
- Small Cell Lung Cancer, Ovarian Cancer, Breast Cancer
- Trial name
- NCT04553133
- Testing
- PF-07104091 monotherapy dose escalation, PF-07104091 + palbociclib + fulvestrant, PF-07104091 + palbociclib + letrozole
- Where
- 22 sites in United States, Argentina and 2 more
- Volunteers
- 157 people
- Sponsor
- Pfizer
Soft Tissue Sarcoma
Molecular Profiling of Advanced Soft-tissue Sarcomas
MULTISARC is a randomized multicenter study assessing whether high throughput molecular analysis (next generation sequencing exome - NGS) is feasible in advanced/metastatic soft-tissue sarcoma patients, that is, whether NGS can…
- Trial name
- MULTISARC (NCT03784014)
- Testing
- Nilotinib, Ceritinib, Capmatinib
- Where
- 17 sites in France
- Volunteers
- 603 people
- Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
Non-Small Cell Lung Cancer, Carcinoma, Squamous Cell
National Lung Matrix Trial: Multi-drug Phase II Trial in Non-Small Cell Lung Cancer
The trial consists of a series of parallel multi-centre single arm phase II trial arms, each testing an experimental targeted drug in a population stratified by multiple pre-specified actionable target putative biomarkers.
- Conditions
- Non-Small Cell Lung Cancer, Carcinoma, Squamous Cell, Adenocarcinoma
- Trial name
- NCT02664935
- Testing
- AZD4547, Vistusertib, Palbociclib
- Where
- 25 sites in United Kingdom
- Volunteers
- 423 people
- Sponsor
- University of Birmingham
HR+/HER2-negative Breast Cancer
A Study to Evaluate the Safety and Tolerability of TOS-358 in Women With HR+ HER2- Breast Cancer
The goal of this clinical trial is to evaluate the safety and efficacy of TOS-358 in women with HR+ HER2- metastatic breast cancer whose tumors have a mutation in PIK3CA and who meet all other study enrollment criteria.
- Trial name
- NCT05683418
- Testing
- TOS-358, Fulvestrant, Palbociclib
- Where
- 18 sites in United States, Spain
- Volunteers
- 241 people
- Sponsor
- Totus Medicines
Head and Neck Squamous Cell Carcinoma
Los Tres Paso: Neoadjuvant Palbociclib Monotherapy, Concurrent Chemoradiation Therapy, Adjuvant Palbociclib Monotherapy in Patients With p16INK4a Negative, HPV-Unrelated Head and Neck Squamous Cell Carcinoma
The purpose of this study is to evaluate the results of treating patients with HPV-unrelated head and neck squamous cell carcinoma with neoadjuvant single-agent palbociclib, followed by chemoradiation (either cisplatin + IMRT or…
- Trial name
- NCT03389477
- Testing
- Palbociclib, Cetuximab, Cisplatin
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Washington University School of Medicine
Acute Lymphoblastic Leukemia, Pediatric, Relapsed Acute Lymphoblastic Leukemia
Palbociclib in Combo w/Chemotherapy in Peds Relapsed/Refractory Acute Lymphoblastic Leukemia
With this research study has following goals To confirm the highest tolerable dose of palbociclib in combination with chemotherapy is safe and well-tolerated.
- Conditions
- Acute Lymphoblastic Leukemia, Pediatric, Relapsed Acute Lymphoblastic Leukemia, Refractory Acute Lymphoblastic Leukemia
- Trial name
- NCT04996160
- Testing
- Palbociclib, Dexamethasone, Bortezomib
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Tanja Andrea Gruber