CLEOPATRA trial results for first-line PERJETA + Herceptin® (trastuzumab)-based HER2+ metastatic breast cancer therapy.

Progression-free survival by independent review (primary endpoint)

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 independent review1

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

Overall survival1

PERJETA demonstrated an OS improvement when combined with Herceptin + docetaxel at the final analysis (secondary endpoint).1

15.7-month improvement in median OS in the final analysis1

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 receptor.
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

7.7 months improved median duration of response (DoR) over Herceptin + docetaxel alone1