Palbociclib After CDK and Endocrine Therapy (PACE)
1 other identifier
interventional
220
1 country
22
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2017
Longer than P75 for phase_2
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 5, 2017
CompletedFirst Posted
Study publicly available on registry
May 10, 2017
CompletedStudy Start
First participant enrolled
September 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedResults Posted
Study results publicly available
December 12, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
ExpectedSeptember 30, 2025
September 1, 2025
5.3 years
May 5, 2017
October 24, 2023
September 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (PFS), According to RECIST v1.1 Criteria (Investigator Assessment)
Progression-Free Survival (PFS), according to RECIST v1.1 criteria (investigator assessment): the time from randomization to the earlier of progression or death due to any cause. Participants alive without disease progression were censored at date of last disease assessment (tumor assessments). The date of progression was the first date that recurrent or progressive disease was objectively documented; if death was the defining event, it must have happened within 2 intervals of the last disease assessment, otherwise PFS was censored at last disease assessment. The length of PFS was calculated as PFS time (months) =\[progression/death date(censor date) - randomization date + 1\]/30.4375.
Tumor were assessed every 8 weeks until 24 weeks, then every 12 weeks. The median PFS follow-up time at database lock was 12.1 months (range 1 day to 50.1 months).
Secondary Outcomes (2)
Overall Response Rate, According to RECIST v1.1 Criteria (Investigator Assessment)
Tumor were assessed every 8 weeks until 24 weeks, then every 12 weeks. The median follow-up time for overall response rate at database lock was 12.1 months (range 1 day to 50.1 months).
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability)
The median follow-up time for adverse event was 5.4 months (range 1.6 months to 51.2 months).
Study Arms (3)
Fulvestrant
ACTIVE COMPARATOR-Fulvestrant will be administered in the clinic as two IM injections on Cycle 1 Days 1, 15, then monthly
Fulvestrant with Palbociclib
EXPERIMENTAL-Palbociclib should be taken orally, once per day for 21 days on a 28 days cyclye -Fulvestrant will be administered in the clinic as two IM injections on Cycle 1 Days 1, 15, then monthly
Fulvestrant with Palbociclib and Avelumab
EXPERIMENTAL-Palbociclib should be taken orally, once per day for 21 days on a 28 days cyclye -Fulvestrant will be administered in the clinic as two IM injections on Cycle 1 Days 1, 15, then monthly -Avelumab will be administered intravebously once every 2 weeks
Interventions
Palbociclib is a drug that may stop cancer cells from growing
Fulvestrant prevents growth of hormone receptor positive breast cancer by blocking stimulation of cancer cells by estrogen
Avelumab is an antibody designed to block the PD-1 pathway and helps the immune system in detecting and fighting cancer cells
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- Pfizercollaborator
Study Sites (22)
University of Miami
Miami, Florida, 33136, United States
Emory University - Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Northwestern University
Chicago, Illinois, 60611, United States
Indiana University
Indianapolis, Indiana, 46202, United States
The University of Kansas Cancer Center - North
Kansas City, Kansas, 64154, United States
The University of Kansas Cancer Center - Overland Park
Overland Park, Kansas, 66210, United States
The University of Kansas Cancer Center
Westwood, Kansas, 66205, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Eastern Maine Medical Center
Bangor, Maine, 04401, United States
Boston Medical Center
Boston, Massachusetts, 02188, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Dana-Farber at St. Elizabeth's Medical Center
Brighton, Massachusetts, 02135, United States
DF/BWCC at Milford Regional Medical Center
Milford, Massachusetts, 01757, United States
DF/BWCC in clinical affiliation with South Shore Hospital
South Weymouth, Massachusetts, 02190, United States
The University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, 64064, United States
Washington University
St Louis, Missouri, 63110, United States
Dana-Farber/New Hampshire Oncology-Hematology
Londonderry, New Hampshire, 03053, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Baylor University
Houston, Texas, 77030, United States
Aurora Cancer Care
Milwaukee, Wisconsin, 53215, United States
Related Publications (1)
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.
PMID: 38513188DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Project Manager
- Organization
- Dana-Farber Cancer Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Erica L Mayer, MD MPH
Dana-Farber Cancer Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Physician, Susan F Smith Center for Women's Cancers
Study Record Dates
First Submitted
May 5, 2017
First Posted
May 10, 2017
Study Start
September 5, 2017
Primary Completion
December 31, 2022
Study Completion (Estimated)
June 30, 2026
Last Updated
September 30, 2025
Results First Posted
December 12, 2023
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share