Trial reportESMO open2026
First-line ET plus palbociclib versus standard mono-chemotherapy in high-risk HR-positive/HER2-negative metastatic breast cancer and indication for chemotherapy: primary results from the randomized phase IV PADMA study.
Trial report in ESMO open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.
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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.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
3 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Comparative efficacy of first- versus second-line CDK4/6 inhibition in hormone receptor-positive, HER2-negative metastatic breast cancer.Breast cancer research : BCR · 2025Pooled it
- Chinese expert consensus on endocrine therapy for breast cancer (2026 edition).Translational breast cancer research : a journal focusing on translational research in breast cancer · 2026Review
- Clinical outcomes of everolimus in patients with hormone receptor positive breast cancer: a real-world analysis.Future oncology (London, England) · 2025Article
Corrections and comments
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Authors and funding
19 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPADMA is a prospective, randomized, open-label, multicenter phase IV study comparing palbociclib and endocrine therapy (ET) with mono-chemotherapy (CT) +/- maintenance ET (at the discretion of the treating physician) as first-line therapy in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR-positive/HER2-negative) metastatic breast cancer (mBC). PATIENTS AND
methodsPatients were randomly assigned 1:1 to receive first-line treatment with palbociclib + ET or investigator-selected CT (capecitabine, epirubicin, paclitaxel, or vinorelbine) +/- maintenance ET. The primary endpoint was time-to-treatment failure (TTF). Secondary endpoints were progression-free survival (PFS), overall survival (OS), safety, and treatment adherence.
resultsOne hundred twenty patients, of whom 106 (88.3%) were postmenopausal, were randomly assigned and started treatment (palbociclib + ET, n = 61; CT, n = 59). Most patients in the CT group received capecitabine (n = 40, 67.8%) or paclitaxel (n = 17, 28.8%). In 13 patients (22%), CT was followed by maintenance ET. At a median follow-up of 36.8 months, the median TTF was 17.2 months with palbociclib + ET versus 6.1 months with CT [hazard ratio 0.46, 95% confidence interval (CI) 0.31-0.69, P < 0.001]. The TTF benefit in subgroups, including AKT signaling alterations or g/tBRCA1/2 mutations, was consistent with that in the overall population. Median PFS was 18.7 months with palbociclib + ET versus 7.8 months with CT (hazard ratio 0.45, 95% CI 0.29-0.70, P < 0.001). OS did not differ significantly between the study arms (P = 0.494). Hematologic toxicity was significantly higher in the palbociclib + ET arm than in the CT-based arm (96.8% versus 70.7%; P < 0.001), although nonhematological toxicity was comparable in both arms.
conclusionPADMA is the first randomized multicenter study to show that palbociclib + ET as first-line treatment compared with CT also leads to improvements in TTF and PFS in predominantly postmenopausal patients with HR-positive/HER2-negative mBC.
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