Palbociclib After CDK and Endocrine Therapy (PACE)

Phase 2 Active not recruiting 220 enrolled Dana-Farber Cancer Institute Pfizer · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

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

Timeline

Start: 2017-09-05
Primary completion: 2022-12-31
Completion: 2026-06-30

Outcome

Missed primary endpoint

paper CONCLUSION: The addition of palbociclib to fulvestrant did not improve PFS versus fulvestrant alone among patients with hormone receptor-positive/HER2- MBC PMID 38513188 ↗

Publications

Mayer EL, Ren Y, Wagle N, Mahtani R, Ma C, DeMichele A, Cristofanilli M, Meisel J, Miller KD, Abdou Y, Riley EC, Qamar R, Sharma P, Reid S, Sinclair N, Faggen M, Block CC, Ko N, Partridge AH, Chen WY, DeMeo M, Attaya V, Okpoebo A, Alberti J, Liu Y, Gauthier E, Burstein HJ, Regan MM, Tolaney SM. PACE: A Randomized Phase II Study of Fulvestrant, Palbociclib, and Avelumab After Progression on Cyclin-Dependent Kinase 4/6 Inhibitor and Aromatase Inhibitor for Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor-Negative Metastatic Breast Cancer. J Clin Oncol. 2024 Jun 10;42(17):2050-2060. doi: 10.1200/JCO.23.01940. Epub 2024 Mar 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Avelumab	Monoclonal antibody	—	Intravenous
Subject	Fulvestrant	Small molecule	—	Intramuscular
Subject	Palbociclib	Small molecule	—	Oral