Phase 3
Completed N=243
A Study to Evaluate the Efficacy and Safety of Pertuzumab + Trastuzumab + Docetaxel Versus Placebo + Trastuzumab + Docetaxel in Previously Untreated Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer
Source: ClinicalTrials.gov NCT02896855 ↗Enrolled (actual)
243
Serious AEs
21.3%
Results posted
Jul 2019
Primary outcomePrimary: Progression-Free Survival, as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) — 12.4; 14.5; 12.5; 16.5 months — p=0.0418
◆ Published Evidence
Established
48citations · ~8 / year
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.
Summary
This Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial in China will evaluate the efficacy and safety of pertuzumab + trastuzumab + docetaxel compared with placebo + trastuzumab + docetaxel in participants with previously untreated HER2-positive metastatic breast cancer.
Linked Publications
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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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival, as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) |
12.4; 14.5; 12.5; 16.5 | 0.0418 sig |
| PRIMARY Kaplan-Meier Estimate of the Percentage of Participants Event-Free for Progression-Free Survival at 1 to 3 Years, as Determined by the Investigator Using RECIST v1.1 |
52.90; 66.37; 19.19; 37.85; 12.73; 29.44 | — |
| SECONDARY Overall Survival |
NA; NA | 0.0658 |
| SECONDARY Kaplan-Meier Estimate of the Percentage of Participants Event-Free for Overall Survival at 1 to 3 Years |
90.64; 93.44; 73.85; 78.87; 58.41; 70.79 | — |
| SECONDARY Percentage of Participants With Measurable Disease at Baseline Who Achieved an Objective Response (Complete or Partial Response), as Determined by the Investigator Using RECIST v1.1 |
69.1; 79.0; 8.2; 5.7; 60.8; 73.3 | 0.1126 |
| SECONDARY Duration of Objective Response, as Determined by the Investigator Using RECIST v1.1 |
10.4; 12.4 | 0.2867 |
| SECONDARY Number of Participants With at Least One Adverse Event |
115; 121; 5 | — |
| SECONDARY Number of Participants With at Least One Grade ≥3 Adverse Event |
83; 90; 1 | — |
| SECONDARY Number of Participants With at Least One Adverse Event Leading to Withdrawal From Any Treatment |
10; 15; 0 | — |
| SECONDARY Number of Participants With Symptomatic Left Ventricular Systolic Dysfunction (LVSD), as Determined Using Echocardiography (ECHO) or Multiple-Gated Acquisition (MUGA) Scan |
0; 0; 0 | — |
| SECONDARY Number of Participants With an Asymptomatic Decline in Left Ventricular Ejection Fraction (LVEF) Event, as Determined Using ECHO or MUGA Scan |
0; 2; 0 | — |
| SECONDARY Number of Participants by the LVEF Abnormality Status Categories Over Time, as Determined by the Change From Baseline in LVEF Using ECHO or MUGA Scans |
57; 63; 51; 52; 3; 4 | — |
| SECONDARY Baseline LVEF and Change From Baseline to Maximum On-Treatment Decrease in LVEF at Any Point During the Study |
64.23; 65.08; -4.88; -5.48 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease that is suitable for chemotherapy
- HER2-positive metastatic breast cancer (MBC)
- Left ventricular ejection fraction (LVEF) greater than or equal to (>=) 55 percent (%) at baseline (within 42 days of randomization)
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Women of childbearing potential and men should agree to use an effective form of contraception and to continue its use for the duration of study treatment and for at least 7 months after the last dose of study treatment (trastuzumab and/or pertuzumab)
Exclusion Criteria
- History of anti-cancer therapy for MBC (with the exception of one prior hormonal regimen for MBC)
- History of approved or investigative tyrosine kinase/HER inhibitors for breast cancer in any treatment setting, except trastuzumab used in the neoadjuvant or adjuvant setting
- History of systemic breast cancer treatment in the neo-adjuvant or adjuvant setting with a disease-free interval from completion of the systemic treatment (excluding hormonal therapy) to metastatic diagnosis of less than ( = 2 hematologic toxicity resulting from previous adjuvant therapy
- Grade >= 3 peripheral neuropathy at randomization
- History of other malignancy within the last 5 years, except for carcinoma in situ of the cervix or non-melanoma skin carcinoma that has been previously treated with curative intent
- Current clinical or radiographic evidence of central nervous system (CNS) metastases
- History of exposure to cumulative doses of anthracyclines
- Current uncontrolled hypertension or unstable angina
- History of congestive heart failure (CHF) of any New York Heart Association (NYHA) classification, or serious cardiac arrhythmia requiring treatment
- History of myocardial infarction within 6 months of randomization
- History of LVEF decrease to < 50% during or after prior trastuzumab neo-adjuvant or adjuvant therapy
- Current dyspnea at rest due to complications of advanced malignancy, or other diseases that require continuous oxygen therapy
- Inadequate organ function within 28 days prior to randomization
- Current severe, uncontrolled systemic disease
- Major surgical procedure or significant traumatic injury within 28 days prior to study treatment start or anticipation of the need for major surgery during the course of study treatment
- Pregnant or lactating women
- History of receiving any investigational treatment within 28 days of randomization
- Current known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or active hepatitis B virus (HBV)
- Receipt of intravenous (IV) antibiotics for infection within 14 days of randomization
- Current chronic daily treatment with corticosteroids (excluding inhaled steroids)
- Known hypersensitivity to any of the protocol-specified study treatments
- Concurrent participation in an interventional or noninterventional study
Data sourced from ClinicalTrials.gov (NCT02896855) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.