drugset

drugset / Trial / NCT03809988

PALbociclib Rechallenge in horMone Receptor-posItive/HER2- Negative Advanced Breast Cancer (PALMIRA)

NCT03809988 ↗

Phase 2 Completed 198 enrolled MedSIR Pfizer · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

Hormone Receptor (HR)-positive/Human Epidermal Growth Factor Receptor 2 (HER2)-negative advanced breast cancer (ABC)

Timeline

Start: 2019-04-05
Primary completion: 2022-11-30
Completion: 2022-11-30

Publications

Llombart-Cussac A, Harper-Wynne C, Perello A, Hennequin A, Fernandez-Ortega A, Colleoni M, Marin S, Quiroga V, Medioni J, Iranzo V, Wheatley D, Del Barco Berron S, Anton A, Dobi E, Ruiz-Borrego M, Alcala-Lopez D, Perez-Escuredo J, Antonarelli G, Sampayo-Cordero M, Perez-Garcia JM, Cortes J. Second-Line Endocrine Therapy With or Without Palbociclib Rechallenge in Patients With Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: PALMIRA Trial. J Clin Oncol. 2025 Jun 20;43(18):2084-2093. doi: 10.1200/JCO-24-01865. Epub 2025 Apr 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Palbociclib	Small molecule	100 mg	Oral
Subject	Palbociclib	Small molecule	125 mg	Oral
Background	Fulvestrant	Small molecule	—	—
Background	Letrozole	Other / unclassified	—	—

Indications