OUTCOMES IN METASTATIC BREAST CANCER
CLEOPATRA trial results for first-line PERJETA + Herceptin® (trastuzumab)-based HER2+ metastatic breast cancer therapy.
Progression-free survival by independent review (primary
Combining PERJETA with Herceptin + docetaxel added 6 months median
progression-free survival (PFS, assessed by independent review).1
6.1-month improvement in median PFS by
CI=confidence interval; HR=hazard ratio.
Median PFS was reached at the first interim analysis.
- At the first interim analysis, PFS events occurred in 191 (47.5%) patients treated with PERJETA + Herceptin + docetaxel and 242 (59.6%) patients treated with Herceptin + docetaxel1
National Comprehensive Cancer Network® (NCCN®) preferred first-line therapy
Pertuzumab + trastuzumab (PERJETA + Herceptin) + docetaxel is the only category 1–preferred first-line therapy for patients with HER2+ metastatic breast cancer (MBC) in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)2
PERJETA demonstrated an OS improvement when combined with Herceptin + docetaxel at the final analysis (secondary endpoint).1
The final OS analysis was performed when 221 patient-deaths occurred in the placebo-treated group and 168 occurred in the PERJETA-treated group.1
Select Important Safety Information
In the treatment of metastatic breast cancer, the most common adverse reactions (>30%) seen with PERJETA in combination with trastuzumab and docetaxel were diarrhea, alopecia, neutropenia, nausea, fatigue, rash, and peripheral neuropathy. The most common NCI-CTCAE v3.0 Grades 3-4 adverse reactions (>2%) were neutropenia, febrile neutropenia, leukopenia, diarrhea, peripheral neuropathy, anemia, asthenia, and fatigue.
PFS and OS by patient subgroups1
PERJETA helped improve both PFS and OS when combined with Herceptin
+ docetaxel in patients with metastatic disease.1,3
- 45% reduced risk of progression or death with PERJETA + Herceptin + docetaxel in the visceral metastases subgroup (n=630; HR for PFS=0.55; 95% CI: 0.45-0.68)4
- 41% reduced risk of death with PERJETA + Herceptin + docetaxel in the visceral metastases subgroup (n=630; HR for OS=0.59; 95% CI: 0.48-0.74)3
- There was an inability to show OS benefit with PERJETA in patients with nonvisceral metastases (n=178; HR=1.11; 95% CI: 0.66-1.85)1
PFS and OS by additional patient subgroups1,3,4
ER=estrogen receptor; PR=progesterone
Twelve patients had unknown hormone receptor status (HR=8.94; 95% CI: 0.56-143.6).
Objective response rate by independent review1
PERJETA-based regimen improved objective response rate (ORR) vs Herceptin + docetaxel alone (P=0.0011)1
CR=complete response; PR=partial response.
- ORR was assessed in patients with measurable disease1,3
- Patients without measurable disease or bone-only disease were not included in the ORR analysis3
- PERJETA Prescribing Information. Genentech, Inc. 2020.
- Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V2.2019. © National Comprehensive Cancer Network, Inc. 2019. All rights reserved. Accessed July 2, 2019. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
- Data on file. Genentech, Inc.
- Baselga J, Cortés J, Kim S-B, et al; CLEOPATRA Study Group. Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer. N Engl J Med. 2012;366:109-119. doi:10.1056/NEJMoa1113216.