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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.

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Affiliations

  • 1. Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.
      Authors
    • Mayer EL 1, 16
    • Wagle N 1, 16
    • Sinclair N 1
    • Faggen M 1
    • Block CC 1, 16
    • Partridge AH 1, 16
    • Chen WY 1, 16
    • DeMeo M 1
    • Attaya V 1
    • Okpoebo A 1
    • Alberti J 1
    • Burstein HJ 1, 16
    • Tolaney SM 1, 16
    (13 authors)
  • 2. Department of Data Science, Dana-Farber Cancer Institute, Boston, MA.
      Authors
    • Ren Y 2
    • Regan MM 2, 16
    (2 authors)
  • 3. Department of Medical Oncology, Miami Cancer Institute, Miami, FL.
      Authors
    • Mahtani R 3
    (1 author)
  • 4. Division of Oncology, Department of Medicine, Washington University School of Medicine, St Louis, MO.
      Authors
    • Ma C 4
    (1 author)
  • 5. Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA.
      Authors
    • DeMichele A 5
    (1 author)
    • Show all (16)

ORCIDs linked to this article

Show all (18)

Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology, 21 Mar 2024, 42(17):2050-2060
https://doi.org/10.1200/jco.23.01940 PMID: 38513188 

Abstract 

Purpose

Cyclin-dependent kinase (CDK) 4/6 inhibitors (CDK4/6is) are an important component of treatment for hormone receptor-positive/human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (MBC), but it is not known if patients might derive benefit from continuation of CDK4/6i with endocrine therapy beyond initial tumor progression or if the addition of checkpoint inhibitor therapy has value in this setting.

Methods

The randomized multicenter phase II PACE trial enrolled patients with hormone receptor-positive/HER2- MBC whose disease had progressed on previous CDK4/6i and aromatase inhibitor (AI) therapy. Patients were randomly assigned 1:2:1 to receive fulvestrant (F), fulvestrant plus palbociclib (F + P), or fulvestrant plus palbociclib and avelumab (F + P + A). The primary end point was investigator-assessed progression-free survival (PFS) in patients treated with F versus F + P.

Results

Overall, 220 patients were randomly assigned between September 2017 and February 2022. The median age was 57 years (range, 25-83 years). Most patients were postmenopausal (80.9%), and 40% were originally diagnosed with de novo MBC. Palbociclib was the most common previous CDK4/6i (90.9%). The median PFS was 4.8 months on F and 4.6 months on F + P (hazard ratio [HR], 1.11 [90% CI, 0.79 to 1.55]; P = .62). The median PFS on F + P + A was 8.1 months (HR v F, 0.75 [90% CI, 0.50 to 1.12]; P = .23). The difference in PFS with F + P and F + P + A versus F was greater among patients with baseline ESR1 and PIK3CA alterations.

Conclusion

The addition of palbociclib to fulvestrant did not improve PFS versus fulvestrant alone among patients with hormone receptor-positive/HER2- MBC whose disease had progressed on a previous CDK4/6i plus AI. The increased PFS seen with the addition of avelumab warrants further investigation in this patient population.

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Read article at publisher's site: https://doi.org/10.1200/jco.23.01940

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