Palbociclib and Endocrine Therapy for LObular Breast Cancer Preoperative Study (PELOPS)
Summary
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 Receptor Positive Breast Cancer.
Timeline
- Start
- 2016-05-24
- Primary completion
- 2022-02
- Completion
- 2031-04
Outcome
Mixed primary results
registry analysis (equivalence test); Tamoxifen With Invasive Ductal vs Letrozole With Invasive Ductal; p = 0.0045; Wilcoxon (Mann-Whitney) NCT02764541 ↗
registry MEAN Tamoxifen With Invasive Ductal: -0.180 (Standard Deviation 2.5) log fold-change NCT02764541 ↗
registry MEAN Letrozole With Invasive Ductal: -1.304 (Standard Deviation 2.2) log fold-change NCT02764541 ↗
registry analysis (equivalence test); Tamoxifen With Invasive Lobular vs Letrozole With Invasive Lobular; p = 0.0161; Wilcoxon (Mann-Whitney) NCT02764541 ↗
registry MEAN Tamoxifen With Invasive Lobular: -0.635 (Standard Deviation 2.5) log fold-change NCT02764541 ↗
registry MEAN Letrozole With Invasive Lobular: -1.944 (Standard Deviation 2.6) log fold-change NCT02764541 ↗
registry analysis (equivalence test); Arm C Endocrine With Palbociclib vs Arm D Endocrine Therapy Alone; p = 0.9288; Wilcoxon (Mann-Whitney) NCT02764541 ↗
Publications
- Grinshpun A, Dustin D, Cai M, Hughes M, DiLullo M, Moore M, Yardley D, Mayer IA, Symmans WF, Mayer EL, Winer EP, Lin NU, Tolaney SM, Metzger O, Jeselsohn R. Circulating tumor DNA in neoadjuvant endocrine therapy for early breast cancer. ESMO Open. 2026 Mar;11(3):106067. doi: 10.1016/j.esmoop.2026.106067. Epub 2026 Feb 10.
- Weiss A, Jin Q, Tayob N, Wrabel E, DeMeo M, Carter J, Constantine M, Faggen M, Block C, Fenton MA, Lo KMS, Openshaw T, Yardley D, Kennedy L, Bedrosian I, Mittendorf EA, Jeselsohn R, Metzger Filho O, King TA. Axillary Management and Outcomes After Neoadjuvant Endocrine Therapy in the Randomized PELOPS Trial. Ann Surg Oncol. 2026 Mar;33(3):2275-2283. doi: 10.1245/s10434-025-18697-5. Epub 2025 Nov 23.
- Weiss A, Revette A, Nava-Coulter B, Mittendorf EA, Filho OM, King TA. Surgeon Perspectives on Axillary Management Following Neoadjuvant Endocrine Therapy: Results from a Qualitative Substudy of the PELOPS Trial. Ann Surg Oncol. 2026 Mar;33(3):2267-2274. doi: 10.1245/s10434-025-18695-7. Epub 2025 Nov 21.
- Hermida-Prado F, Xie Y, Sherman S, Nagy Z, Russo D, Akhshi T, Chu Z, Feit A, Campisi M, Chen M, Nardone A, Guarducci C, Lim K, Font-Tello A, Lee I, Garcia-Pedrero J, Canadas I, Agudo J, Huang Y, Sella T, Jin Q, Tayob N, Mittendorf EA, Tolaney SM, Qiu X, Long H, Symmans WF, Lin JR, Santagata S, Bedrosian I, Yardley DA, Mayer IA, Richardson ET, Oliveira G, Wu CJ, Schuster EF, Dowsett M, Welm AL, Barbie D, Metzger O, Jeselsohn R. Endocrine Therapy Synergizes with SMAC Mimetics to Potentiate Antigen Presentation and Tumor Regression in Hormone Receptor-Positive Breast Cancer. Cancer Res. 2023 Oct 2;83(19):3284-3304. doi: 10.1158/0008-5472.CAN-23-1711.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Letrozole | Other / unclassified | — | — |
| Subject | Palbociclib | Small molecule | — | — |
| Subject | Tamoxifen | Small molecule | — | — |