Evidence map›Paper›PMID 40140172›Full record

Trial reportBreast cancer research and treatment2025

Impact of adding palbociclib on treatment adherence to ongoing adjuvant endocrine treatment in the global randomized PALLAS randomized trial in patients with early breast cancer.

Eileen Shinn, David Zahrieh, Angela DeMichele, Nick Zdenkowski, Julie Lemieux, Jun Mao, Vesna Bjelic-Radisic, Michelle J Naughton, Georg Pfeiler, Karen Gelmon and 33 more

Erratum issued Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Breast cancer research and treatment, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT02513394 (PALbociclib CoLlaborative Adjuvant Study), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02513394 phase3active not recruitingnot on this map

PALbociclib CoLlaborative Adjuvant Study: A Randomized Phase III Trial of Palbociclib With Standard Adjuvant Endocrine Therapy Versus Standard Adjuvant Endocrine Therapy Alone for Hormone Receptor Positive (HR+) / Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Early Breast Cancer

TypeinterventionalSponsorAlliance Foundation Trials, LLC.Ran2015 to 2028Enrolled5,796ConditionsBreast CancerArmsPalbociclib, Standard Adjuvant Endocrine Therapy
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

43 authors.

Eileen ShinnThe University of Texas MD Anderson Cancer Center, Houston, TX, USA. eshinn@mdanderson.org.
David ZahriehMayo Clinic, Rochester, MN, USA.
Angela DeMicheleECOG, University of Pennsylvania, Philadelphia, PA, USA.
Nick ZdenkowskiThe University of Newcastle, Callaghan, NSW, Australia.
Julie LemieuxCentre Hospitalier Universitaire de Québec-Université Laval, Quebec, Canada.
Jun MaoMemorial Sloan Kettering Cancer Center, New York, NY, USA.
Vesna Bjelic-RadisicHelios University Clinic Wuppertal, University Witten/Herdecke Germany, Wuppertal, Germany.
Michelle J NaughtonOhio State University/Alliance, Columbus, OH, USA.
Georg PfeilerDepartment of Obstetrics and Gynecology, Comprehensive Cancer Center Vienna, Medical University of Vienna, Vienna, Austria.
Karen GelmonUniversity of British Columbia, Vancouver, BC, Canada.
Justin M BalkoVanderbilt University Medical Center, Nashville, TN, USA.
Daniel EgleMedical University of Innsbruck, Innsbruck, Austria.
Gabriele ZoppoliGruppo Oncologico Italiano di Ricerca Clinica (GOIRC), Policlinico San Martino IRCCS, University of Genoa, Genoa, Italy.
Tiffany TrainaMemorial Sloan Kettering Cancer Center, New York, NY, USA.
Miguel Martin JimenezGEICAM, Hospital General Universitario Gregorio Marañón, Universidad Complutense, Madrid, Spain.
Silvia Antolin NovoaA Coruña University Hospital, A Coruna, Spain.
Tufia HaddadMayo Clinic, Rochester, MN, USA.
Arlene ChanBreast Cancer Research Centre, Nedlands, WA, Australia.
Alistair RingThe Royal Marsden Hospital, NHS Foundation Trust, East Sussex, UK.
Antonio WolffJohns Hopkins University/ECOG, Baltimore, MD, USA.
William Fraser SymmansThe University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Jose Ponce LorenzoGEICAM, Hospital General Universitario Gregorio Marañón, Universidad Complutense, Madrid, Spain.
Dhanusha SabanathanLakeside Specialist Breast Clinic, Nepean Cancer Care Centre, Norwest, NSW, Australia.
Hal J BursteinDana-Farber Cancer Institute, Boston, MA, USA.
Zbigniew Ireneusz NoweckiThe Maria Sklodowska Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland.
Gunda Pristauz-TelsniggMedical University of Graz, Graz, Austria.
Adam BrufskyUniversity of Pittsburgh Cancer Institute UPMC Hillman Cancer Center, Pittsburgh, PA, USA.
Meritxell Bellet-EzquerraVall d'Hebron Institute of Oncology, Barcelona, Spain.
Theodoros FoukakisKarolinska Institute and University Hospital, Solna, Sweden.
Yelena NovikNew York University, New York, NY, USA.
Gabor RubovszkyNational Institute of Oncology, Budapest, Hungary.
Christian F SingerDepartment of Obstetrics and Gynecology, Comprehensive Cancer Center Vienna, Medical University of Vienna, Vienna, Austria.
Karoline MuehlbacherAustrian Breast and Colorectal Cancer Study Group AT, Vienna, Austria.
Otto Metzger FilhoDana-Farber Cancer Institute, Boston, MA, USA.
Theodora GouliotiBreast International Group, Brussels, Belgium.
Ernest LawPfizer, Chicago, IL, USA.
Ann H PartridgeDana-Farber Cancer Institute, Boston, MA, USA.
Lisa A CareyUniversity of North Carolina/Alliance, Chapel Hill, NC, USA.
Alex ZoroufyMayo Clinic, Rochester, MN, USA.
Dominik HlauschekAustrian Breast and Colorectal Cancer Study Group AT, Vienna, Austria.
Christian FeslAustrian Breast and Colorectal Cancer Study Group AT, Vienna, Austria.
Erica L Mayer *Dana-Farber Cancer Institute, Boston, MA, USA.
Michael Gnant *Austrian Breast and Colorectal Cancer Study Group AT, Vienna, Austria.

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Fabien Delerue · 1985 to 2026
$290.8M
Alliance Foundation Trials AFT-05Austrian Breast and Colorectal Cancer Study Group ABCSG-42NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

purposeUsing patient-reported outcomes (PROs) and more objective measures, we evaluated adherence to adjuvant palbociclib and ET in the PALLAS trial, and the impact of palbociclib on ET adherence.

methodsThe open-label, global, phase 3 PALLAS trial randomized patients with hormone receptor-positive (HR+), HER2-negative stage II-III breast cancer (1:1) to either 26 cycles of palbociclib (125 mg/day for 21 days and then 7 days off) plus adjuvant ET, versus ET alone. After 23.7 months median follow-up, palbociclib was stopped due to futility of the intervention and patients were moved to follow-up. For each cycle, daily adherence to ET was measured with study diaries; for palbociclib, study diaries and pill counts. At cycles 2, 3, 6, 12, 18 and 24, patients completed the Morisky Medication Adherence Scale-4 plus an additional item and the McHorney Adherence Questionnaire. Mean persistence was defined in months from treatment initiation to cessation.

resultsFour thousand six hundred eighty-eight of 5796 total PALLAS participants were included. Across all cycles, mean daily ET adherence values measured by study diary were > 98.0% and did not differ between treatment arms. Mean persistence to ET was similar between arms (19.2 months for palbociclib + ET vs. 19.6 months for ET alone). However, patient-reported maximal ET adherence was higher across time for palbociclib + ET compared to ET alone (p ≤ 0.0001, modified MMAS-4; p = 0.05, McHorney).

conclusionIn the PALLAS trial, addition of palbociclib did not decrease adherence to adjuvant ET. Though numbers declined over time, daily adherence for palbociclib and ET remained relatively high at each cycle.

trial registrationThe trial is registered with ClinicalTrials.gov (NCT02513394; 07-31-2015) and EudraCT (2014-005181-30).

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsMedication AdherencePiperazinesPyridinesAdultAgedChemotherapy, AdjuvantFemaleHumansMiddle AgedNeoplasm StagingPatient Reported Outcome MeasuresTreatment OutcomepalbociclibPiperazinesPyridinesAdherenceAdjuvant endocrine therapyPalbociclibPALLASPatient-reported outcomes

Identifiers

What OpenQuestion holds

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Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.