Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2022
Treatment Exposure and Discontinuation in the PALbociclib CoLlaborative Adjuvant Study of Palbociclib With Adjuvant Endocrine Therapy for Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Early Breast Cancer (PALLAS/AFT-05/ABCSG-42/BIG-14-03).
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers.
What it found
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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.
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Who cites it
30 citing papers in PubMed, 42 citations in OpenAlex.
- 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.Breast cancer research and treatment · 2025Trial
- Outcomes in stage IIA versus stage IIB/III in the PALLAS trial [ABCSG-42/AFT-05/PrE0109/BIG-14-13]).Breast cancer research : BCR · 2025Trial
- Metformin, placebo, and endocrine therapy discontinuation among participants in a randomized double-blind trial of metformin vs placebo in hormone receptor-positive early-stage breast cancer (CCTG MA32).Breast cancer research and treatment · 2023Trial
- Review
- Effects of intermittent discontinuation cyclin-dependent kinase inhibitors on metastatic breast cancer during Lebanon's economic crisis.Breast cancer research and treatment · 2025Article
- Efficacy and Predictability of Cyclin-Dependent Kinase 4/6 Inhibitors in HER2-Positive Breast Cancer.Cancers · 2025Review
- Breast cancer: pathogenesis and treatments.Signal transduction and targeted therapy · 2025Review
- Review
- Clinician's guide: expert insights on the use of CDK4/6 inhibitors in patients with early breast cancer.Therapeutic advances in medical oncology · 2025Review
- A Real-World Comparison Between Adjuvant Docetaxel with Cyclophosphamide (TC) and Anthracycline-Taxane Chemotherapy in Early HER-2 Negative Breast Cancer.Current oncology (Toronto, Ont.) · 2024Article
- Quality of life in women with early-stage and metastatic hormone receptor-positive, HER2-negative breast cancer receiving endocrine therapy.The oncologist · 2024Observational
- Updates in Systemic Treatment of Hormone Receptor-Positive Early-Stage Breast Cancer.Current treatment options in oncology · 2024Review
- Quantification of Letrozole, Palbociclib, Ribociclib, Abemaciclib, and Metabolites in Volumetric Dried Blood Spots: Development and Validation of an LC-MS/MS Method for Therapeutic Drug Monitoring.International journal of molecular sciences · 2024Article
- Cyclin-Dependent Kinase 4/6 Inhibitors Plus Endocrine Therapy versus Endocrine Therapy Alone for HR-Positive, HER-2-Negative Early Breast Cancer: Meta-Analysis of Phase III Randomized Clinical Trials.Journal of personalized medicine · 2024Review
- A narrative review: research progress of adjuvant intensive endocrine therapy for early breast cancer.Translational breast cancer research : a journal focusing on translational research in breast cancer · 2024Review
- Too Much, Too Little, or Just Right? Obesity and Dosing of Targeted Therapies in Breast Cancer.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023Article
- The Role of Cyclin-Dependent Kinases (CDK) 4/6 in the Ovarian Tissue and the Possible Effects of Their Exogenous Inhibition.Cancers · 2023Review
- Adjuvant Targeted Therapy in Solid Cancers: Pioneers and New Glories.Journal of personalized medicine · 2023Review
- Appraisal of Systemic Treatment Strategies in Early HER2-Positive Breast Cancer-A Literature Review.Cancers · 2023Review
- Recent advances in targeted strategies for triple-negative breast cancer.Journal of hematology & oncology · 2023Review
Corrections and comments
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Authors and funding
33 authors at 20 institutions in 10 countries.
Funding
Abstract
purposeThe PALLAS study investigated whether the addition of palbociclib, an oral CDK4/6 inhibitor, to adjuvant endocrine therapy (ET) improves invasive disease-free survival (iDFS) in early hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. In this analysis, we evaluated palbociclib exposure and discontinuation in PALLAS.
methodsPatients with stage II-III HR+, HER2- disease were randomly assigned to 2 years of palbociclib with adjuvant ET versus ET alone. The primary objective was to compare iDFS between arms. Continuous monitoring of toxicity, dose modifications, and early discontinuation was performed. Association of baseline covariates with time to palbociclib reduction and discontinuation was analyzed with multivariable competing risk models. Landmark and inverse probability weighted per-protocol analyses were performed to assess the impact of drug persistence and exposure on iDFS.
resultsOf the 5,743 patient analysis population (2,840 initiating palbociclib), 1,199 (42.2%) stopped palbociclib before 2 years, the majority (772, 27.2%) for adverse effects, most commonly neutropenia and fatigue. Discontinuation of ET did not differ between arms. Discontinuations for non-protocol-defined reasons were greater in the first 3 months of palbociclib, and in the first calendar year of accrual, and declined over time. No significant relationship was seen between longer palbociclib duration or ≥ 70% exposure intensity and improved iDFS. In the weighted per-protocol analysis, no improvement in iDFS was observed in patients receiving palbociclib versus not (hazard ratio 0.89; 95% CI, 0.72 to 1.11).
conclusionDespite observed rates of discontinuation in PALLAS, analyses suggest that the lack of significant iDFS difference between arms was not directly related to inadequate palbociclib exposure. However, the discontinuation rate illustrates the challenge of introducing novel adjuvant treatments, and the need for interventions to improve persistence with oral cancer therapies.
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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.