Clinical trials: Palbociclib
HER-2 Positive Breast Cancer, Estrogen Receptor Positive Breast Cancer
Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer
The primary objective of this study is to demonstrate that the combination of palbociclib with anti-HER2 therapy plus endocrine therapy is superior to anti-HER2-based therapy plus endocrine therapy alone in improving the outcomes…
- Trial name
- PATINA (NCT02947685)
- Testing
- palbociclib, trastuzumab, pertuzumab
- Where
- 108 sites in United States, Australia and 6 more
- Volunteers
- 518 people
- Sponsor
- Alliance Foundation Trials, LLC.
Breast Cancer, Estrogen Receptor Positive Tumor
To Reduce the Use of Chemotherapy in Postmenopausal Patients With ER-positive and HER2-positive Breast Cancer (TOUCH)
This is a phase II open-label, multicentre, randomized trial. The study assesses the treatment of postmenopausal patients with hormone receptor positive/HER2 positive early breast cancer with neoadjuvant palbociclib in…
- Conditions
- Breast Cancer, Estrogen Receptor Positive Tumor, HER2-positive Breast Cancer
- Trial name
- TOUCH (NCT03644186)
- Testing
- Paclitaxel, Trastuzumab, Pertuzumab
- Where
- 54 sites in Belgium, France and 2 more
- Volunteers
- 147 people
- Sponsor
- ETOP IBCSG Partners Foundation
Estrogen Receptor-positive Breast Cancer, HER2/Neu Negative
Testing the Effects of Palbociclib and Fulvestrant or Letrozole for Patients 70 Years of Age of Older With Metastatic Breast Cancer
This phase II trial studies the side effects and how well palbociclib and letrozole or fulvestrant works in treating patients aged 70 years and older with estrogen receptor positive, HER2 negative breast cancer that has spread to…
- Conditions
- Estrogen Receptor-positive Breast Cancer, HER2/Neu Negative, Stage IV Breast Cancer AJCC v6 and v7
- Trial name
- NCT03633331
- Testing
- Palbociclib, Letrozole, Fulvestrant
- Where
- 447 sites in United States
- Volunteers
- 93 people
- Sponsor
- Alliance for Clinical Trials in Oncology
Ewing Sarcoma, Solid Tumors
Study Of Palbociclib Combined With Chemotherapy In Pediatric Patients With Recurrent/Refractory Solid Tumors
A study to learn about safety and find out maximum tolerable dose of palbociclib given in combination with chemotherapy (temozolomide with irinotecan or topotecan with cyclophosphamide) in children, adolescents and young adults…
- Conditions
- Ewing Sarcoma, Solid Tumors, Rhabdoid Tumor, Rhabdomyosarcoma
- Trial name
- NCT03709680
- Testing
- Palbociclib, Temozolomide, Irinotecan
- Where
- 84 sites in United States, Brazil and 11 more
- Volunteers
- 128 people
- Sponsor
- Pfizer
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.
Breast Neoplasms
PD 0332991 and Anastrozole for Stage 2 or 3 Estrogen Receptor Positive and HER2 Negative Breast Cancer
A Phase II study to investigate the potential utility of PD 0332991 in the treatment of early stage ER+ Human epidermal growth factor receptor 2 (HER2)- breast cancer, to investigate whether the combination of PD 0332991 and…
- Trial name
- NCT01723774
- Testing
- PD0332991, Anastrozole, Goserelin
- Where
- 4 sites in United States
- Volunteers
- 84 people
- Sponsor
- Washington University School of Medicine
HER2+/HR+ Breast Cancer
Phase 2a Study of ZW25 in Combination With Palbociclib Plus Fulvestrant
This is a multicenter, Phase 2a, open-label, 2-part study to investigate the safety, tolerability, and anti-tumor activity of ZW25 (zanidatamab) in combination with palbociclib plus fulvestrant.
- Trial name
- NCT04224272
- Testing
- ZW25 (Zanidatamab), Palbociclib, Fulvestrant
- Where
- 13 sites in United States, Canada and 1 more
- Volunteers
- 51 people
- Sponsor
- Jazz Pharmaceuticals
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
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
Breast Cancer
A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Participants With PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer
This study will evaluate the efficacy, safety, and pharmacokinetics of inavolisib in combination with palbociclib and fulvestrant compared with placebo plus palbociclib and fulvestrant in participants with PIK3CA-mutant, hormone…
- Trial name
- INAVO120 (NCT04191499)
- Testing
- Inavolisib, Palbociclib, Fulvestrant
- Where
- 135 sites in United States, Argentina and 26 more
- Volunteers
- 325 people
- Sponsor
- Hoffmann-La Roche
Receptors, Estrogen, Genes, Erbb-2
A Study of H3B-6545 in Combination With Palbociclib in Women With Advanced or Metastatic Estrogen Receptor-Positive Human Epidermal Growth Factor Receptor-2 (HER2)-Negative Breast Cancer
The primary objective of this study is to evaluate the safety and tolerability of H3B-6545 and palbociclib when administered in combination in order to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2…
- Conditions
- Receptors, Estrogen, Genes, Erbb-2, Breast Neoplasms
- Trial name
- NCT04288089
- Testing
- Palbociclib (75, 100, 125 milligram [mg]), H3B-6545 (150, 300, 450 mg)
- Where
- 8 sites in United States, United Kingdom
- Volunteers
- 31 people
- Sponsor
- Eisai Inc.
Metastatic Breast Cancer
Palbociclib in Molecularly Characterized ER-positive/HER2-negative Metastatic Breast Cancer
This international, multicenter, prospective single arm Phase II biomarker discovery clinical trial with the primary objective of assessing the association of PFS with gene mutations, gene copy number aberrations and gene…
- Trial name
- PYTHIA (NCT02536742)
- Testing
- Palbociclib, Fulvestrant
- Where
- 19 sites in Belgium, Italy and 1 more
- Volunteers
- 124 people
- Sponsor
- ETOP IBCSG Partners Foundation
Advanced Malignant Solid Neoplasm, Ann Arbor Stage III Non-Hodgkin Lymphoma
Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial)
This phase II Pediatric MATCH screening and multi-sub-trial studies how well treatment that is directed by genetic testing works in pediatric patients with solid tumors, non-Hodgkin lymphomas, or histiocytic disorders that have…
- Conditions
- Advanced Malignant Solid Neoplasm, Ann Arbor Stage III Non-Hodgkin Lymphoma, Ann Arbor Stage IV Non-Hodgkin Lymphoma, Histiocytic Sarcoma
- Trial name
- NCT03155620
- Testing
- Biopsy Procedure, Biospecimen Collection, Bone Marrow Aspiration and Biopsy
- Where
- 172 sites in United States, Australia and 2 more
- Volunteers
- 1,377 people
- Sponsor
- National Cancer Institute (NCI)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Testing Palbociclib (PD-0332991) as Potentially Targeting Treatment in Cancers With CDK4 or CDK6 Amplification (MATCH - Subprotocol Z1C)
This phase II MATCH treatment trial tests how well palbociclib (PD-0332991) works in treating patients with cancer that has certain genetic changes. Palbociclib (PD-0332991) is in a class of medications called kinase inhibitors.
- Conditions
- Advanced Lymphoma, Advanced Malignant Solid Neoplasm, Refractory Lymphoma, Refractory Malignant Solid Neoplasm
- Trial name
- NCT06390839
- Testing
- Biopsy Procedure, Biospecimen Collection, Computed Tomography
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- National Cancer Institute (NCI)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Testing Palbociclib (PD-0332991) as a Potential Targeted Treatment in Cancers With CCND1, 2, 3 Amplification (MATCH-Subprotocol Z1B)
This phase II MATCH treatment trial identifies the effects of palbociclib in patients whose cancer has genetic changes called CCND1, 2, or 3 amplification.
- Conditions
- Advanced Lymphoma, Advanced Malignant Solid Neoplasm, Hematopoietic and Lymphoid Cell Neoplasm, Refractory Lymphoma
- Trial name
- NCT04439201
- Testing
- Palbociclib
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- National Cancer Institute (NCI)
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 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
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
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