METASTATIC BREAST CANCER TRIAL DESIGN


The CLEOPATRA trial was a multicenter, randomized, double-blind, placebo-controlled Phase III trial that evaluated first-line (1L) PERJETA and Herceptin® (trastuzumab)-based therapy for patients with HER2+ metastatic breast cancer.

CLEOPATRA trial schema1,2

*Stratified by prior treatment status (de novo or prior adjuvant/neoadjuvant therapy) and geographic region.
All therapies administered every 3 weeks.
PERJETA dosing:
840 mg loading dose over 60 minutes; 420 mg over 30-60 minutes for subsequent infusions. Herceptin dosing: 8 mg/kg loading dose over 90 minutes; 6 mg/kg over 30-90 minutes for subsequent infusions. Docetaxel dosing: 75 mg/m² over 60 minutes for ≥6 cycles. Dose could be decreased by 25% due to toxicity or increased to 100 mg/m² in those patients who could tolerate this dose; <6 cycles were allowed for unacceptable toxicity.1,2
HER2 overexpression was defined as IHC 3+ or FISH amplification ratio ≥2.0. IHC 3+ is defined as uniform, intense membrane staining in >10% of tumor cells. Patients with a ≥12-month disease-free interval following adjuvant or neoadjuvant therapy, or one prior hormonal treatment for MBC were eligible for enrollment.

IHC=immunohistochemistry; FISH=fluorescence in situ hybridization.

CLEOPATRA trial endpoints included PFS, OS, and safety

Primary endpoint1

  • Progression-free survival (PFS; as assessed by an independent review facility [IRF]), defined as time from randomization to documented progressive disease as determined by RECIST, or death

Select secondary endpoints1

  • Overall survival (OS)
  • Investigator-assessed PFS
  • Objective response rate (ORR)
  • Duration of response (DoR)
  • Safety

RECIST=response evaluation criteria in solid tumors, version 1.0.

Learn about the CLEOPATRA trial outcomes and safety profile.

Select patient demographics in CLEOPATRA

Baseline patient characteristics were well balanced across treatment arms2

ECOG=Eastern Cooperative Oncology Group; ER=estrogen receptor; PR=progesterone receptor.

Patients may have received more than one form of adjuvant or neoadjuvant chemotherapy.

References