Published August 2020
| Version v1
Journal article
Pertuzumab, trastuzumab, and docetaxel for Chinese patients with previously untreated HER2-positive locally recurrent or metastatic breast cancer (PUFFIN): a phase III, randomized, double-blind, placebo-controlled study
Creators
- 1. Chinese Academy of Medical Sciences, and Peking Union Medical College. National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital (China)
- 2. The First Hospital of Jilin University. The Cancer Center (China)
- 3. Harbin Medical University (China)
- 4. Fudan University Shanghai Cancer Center (China)
- 5. Zhejiang Cancer Hospital (China)
- 6. Beijing Cancer Hospital (China)
- 7. Liaoning Cancer Hospital & Institute. Cancer Hospital of China Medical University (China)
- 8. Jiangsu Province Hospital (China)
- 9. Sichuan University. West China Hospital (China)
- 10. Jiangsu Cancer Hospital (China)
- 11. Janssen China R&D (China)
- 12. Roche Holding Ltd (China)
- 13. Roche Products Limited (United Kingdom)
- 14. F. Hoffmann-La Roche Ltd (Switzerland)
Description
Purpose
: The Chinese bridging study PUFFIN (NCT02896855) aimed to assess consistency of efficacy with CLEOPATRA (NCT00567190), investigating pertuzumab with trastuzumab and docetaxel versus placebo, trastuzumab, and docetaxel in patients with previously untreated HER2-positive locally recurrent or metastatic breast cancer.Methods
: Patients were randomized 1:1, stratified by visceral/non-visceral disease and hormone receptor status. The primary endpoint was investigator-assessed progression-free survival (PFS). Secondary endpoints included objective response rate (in patients with measurable baseline disease), overall survival, and safety. The consistency threshold for PFS (hazard ratio [HR] < 0.81) (maintaining ≥ 50% of the risk reduction determined in CLEOPATRA [HR 0.62]) determined the target sample size (n = 240).Results
: Two hundred forty-three patients were randomized. Median PFS was 14.5 months in the pertuzumab arm (95% confidence interval [CI] 12.5, 18.6) and 12.4 months in the placebo arm (95% CI 10.4, 12.7) in the intention-to-treat population (HR: 0.69 [95% CI 0.49, 0.99]). Objective responses were recorded in 83/105 (79.0%) and 67/97 (69.1%) patients, respectively. Grade ≥ 3 adverse events (70.5% and 69.2%, respectively) and serious adverse events (19.7% and 19.2%, respectively) were similar across both arms. No heart failure cases or symptomatic left ventricular ejection fraction declines were reported.Conclusions
: PUFFIN met its primary objective. Overall, efficacy data were consistent with CLEOPATRA. Safety was consistent with the known pertuzumab safety profile. PUFFIN adds 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 patientsTrial registration
: ClinicalTrials.gov, NCT02896855, registered 7 September 2016Additional details
Identifiers
Publishing Information
- Journal Title
- Breast Cancer Research and Treatment
- Journal Volume
- 182
- Journal Issue
- 3
- Journal Page Range
- p. 689-697
- ISSN
- 0167-6806
- CODEN
- BCTRD6
INIS
- Country of Publication
- Netherlands
- Country of Input or Organization
- International Atomic Energy Agency (IAEA)
- INIS RN
- 55060592
- Subject category
- S62: RADIOLOGY AND NUCLEAR MEDICINE;
- Descriptors DEI
- AUC; CARDIOVASCULAR DISEASES; CHEMOTHERAPY; CHINA; CLINICAL TRIALS; HEALTH HAZARDS; HEART; HEART FAILURE; MAMMARY GLANDS; METASTASES; NEOPLASMS; PATIENTS; RECEPTORS; SAFETY; STANDARD OF LIVING; SURVIVAL TIME
- Descriptors DEC
- ACTINIDE COMPOUNDS; AMMONIUM CARBONATES; AMMONIUM COMPOUNDS; ASIA; BODY; CARBON COMPOUNDS; CARBONATES; CARDIOVASCULAR SYSTEM; DISEASES; GLANDS; HAZARDS; MEDICINE; MEMBRANE PROTEINS; ORGANIC COMPOUNDS; ORGANS; OXYGEN COMPOUNDS; PROTEINS; SYMPTOMS; TESTING; THERAPY; URANIUM COMPOUNDS; URANYL COMPOUNDS
Optional Information
- Copyright
- Copyright (c) 2020 © The Author(s) 2020