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