Trial reportBreast cancer research and treatment2023
Pertuzumab, trastuzumab, and docetaxel for Chinese patients with previously untreated HER2-positive locally recurrent or metastatic breast cancer (PUFFIN): final analysis of a phase III, randomized, double-blind, placebo-controlled study.
Trial report in Breast cancer research and treatment, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 21 papers, 2 of them syntheses that pooled it.
What it found
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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.
A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-Positive Metastatic Breast Cancer
A Phase III, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Pertuzumab+Herceptin+Docetaxel Versus Placebo+Herceptin+Docetaxel in Previously Untreated HER2-Positive Metastatic Breast Cancer
A Multicenter, Randomized, Open-Label, Controlled Phase II Clinical Study of Paclitaxel Polymeric Micelles Combined With Trastuzumab and Pertuzumab (HP) and Adebelimab Versus Taxane Combined With HP as First-Line Treatment for Advanced HER2-Positive Breast Cancer
Who cites it
21 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Pertuzumab in Combination with Trastuzumab and Docetaxel as Adjuvant Doublet Therapy for HER2-Positive Breast Cancer: A Systematic Review.International journal of molecular sciences · 2025Pooled it
- Efficacy and safety of first-line therapy in patients with HER2-positive advanced breast cancer: a network meta-analysis of randomized controlled trials.Journal of cancer research and clinical oncology · 2024Pooled it
- A phase I, randomized, double-blind, parallel, single-dose pharmacokinetic study to evaluate the biosimilarity of KM118 (proposed pertuzumab biosimilar) with reference pertuzumab (PerjetaAnnals of medicine · 2025Trial
- Longitudinal tissue analysis reveals microenvironmental changes correlate with combined immunotherapy and targeted therapy response in metastatic breast cancer.Journal for immunotherapy of cancer · 2025Trial
- Dalpiciclib combined with pyrotinib and endocrine therapy in women with ER-positive, HER2-positive advanced breast cancer: A prospective, multicenter, single-arm, phase 2 trial.PLoS medicine · 2025Trial
- Efficacy and safety of KN026 and docetaxel for HER2-positive breast cancer: a phase II clinical trial.Cancer communications (London, England) · 2025Trial
- Trastuzumab Biosimilar (HLX02), Pertuzumab Plus Chemotherapy in Patients with HER2-Positive Metastatic Breast Cancer after Progression of Trastuzumab: A Prospective, Phase II Study.Cancer research and treatment · 2024Trial
- Spatial molecular analyses reveal key features associated with response to KN026 in advanced HER2-positive breast cancer.British journal of cancer · 2026Article
- Real-world outcomes of first-line treatment with HLX02 versus reference trastuzumab plus pertuzumab in HER2-positive metastatic breast cancer.The oncologist · 2025Article
- Advances in Molecular Diagnostics and Targeted Therapeutic Approaches in HER-2 Positive Breast Cancer.Asian Pacific journal of cancer prevention : APJCP · 2025Review
- Real-world treatment patterns and outcomes among patients with HER2-positive unresectable or metastatic breast cancer in China.Frontiers in oncology · 2025Article
- DESTINY-Breast09, new breakthroughs in first-line therapy for HER2-positive advanced breast cancer.Translational breast cancer research : a journal focusing on translational research in breast cancer · 2025Article
- Efficacy and safety of first-line regimens for advanced HER2-positive breast cancer: A Bayesian network meta-analysis.Cancer innovation · 2024Article
- Guidelines for diagnosis and treatment of advanced breast cancer in China (2022 edition).Journal of the National Cancer Center · 2024Article
- Exploring the Combined Action of Adding Pertuzumab to Branded Trastuzumab versus Trastuzumab Biosimilars for Treating HER2+ Breast Cancer.International journal of molecular sciences · 2024Article
- Pyrotinib in combination with first-line trastuzumab and docetaxel for patients with HER2-positive metastatic breast cancer: a new therapeutic option?Nature reviews. Clinical oncology · 2024Article
- Application and challenge of HER2DX genomic assay in HER2+ breast cancer treatment.American journal of cancer research · 2024Review
- Inetetamab-based therapy in real-world treatment patterns with HER2-positive advanced breast cancer patients: a retrospective single-center study.Therapeutic advances in medical oncology · 2024Article
- Inetetamab combined with pyrotinib and oral vinorelbine for patients with human epidermal growth factor receptor 2 positive advanced breast cancer: A single-arm phase 2 clinical trial.Cancer pathogenesis and therapy · 2024Article
- A disproportionality analysis of adverse events associated to pertuzumab in the FDA Adverse Event Reporting System (FAERS).BMC pharmacology & toxicology · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposePUFFIN (NCT02896855), a Chinese bridging study in patients with previously untreated HER2-positive locally recurrent or metastatic breast cancer, assessed consistency of efficacy and safety of pertuzumab plus trastuzumab and docetaxel versus placebo, trastuzumab, and docetaxel, with CLEOPATRA (NCT00567190).
methodsEligible patients, n = 243, were randomized 1:1, stratified by visceral disease and hormone receptor status, to pertuzumab, trastuzumab, and docetaxel or placebo, trastuzumab, and docetaxel. PRIMARY ENDPOINT: investigator-assessed progression-free survival (PFS). Secondary endpoints: safety and overall survival (OS). After primary analysis, patients could cross over to the pertuzumab arm.
resultsUpdated median PFS: 16.5 months (pertuzumab arm) and 12.5 months (placebo arm), with a hazard ratio (HR) of 0.60 [95% confidence interval (CI) 0.45, 0.81; p = 0.0008]. Median OS was not reached in either arm; the OS HR was 0.68 (95% CI 0.45, 1.03; p = 0.0658). Safety was similar in both arms with no new safety signals: 73.8% (pertuzumab arm) and 69.2% (placebo arm) experienced grade ≥ 3 adverse events. No heart failure, symptomatic left ventricular systolic dysfunction, or left ventricular ejection fraction decline of < 40% were reported.
conclusionsThe PUFFIN final analysis showed, per the primary analysis, that overall efficacy of pertuzumab plus trastuzumab and docetaxel was consistent with CLEOPATRA. Safety remained consistent with the known pertuzumab profile. Overall, PUFFIN contributes to the totality of data with pertuzumab in previously untreated HER2-positive locally recurrent or metastatic breast cancer and supports the favorable benefit-risk profile of pertuzumab in Chinese patients.
trial registrationClinicalTrials.gov, NCT02896855, registered 7 September 2016.
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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.