CLEOPATRA

Phase 3

Completed

• Conditions: Breast Cancer

• Registration Number: JPRN-jRCT2080220775
• Lead Sponsor: Chugai Pharmaceutical Co., Ltd.

Brief Summary

The combination of pertuzumab plus trastuzumab plus docetaxel, as compared with placebo plus trastuzumab plus docetaxel, when used as first-line treatment for HER2-positive metastatic breast cancer, significantly prolonged progression-free survival, with no increase in cardiac toxic effects.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-22
• Results First Posted: 2011-12-07
• Study Completion: 2018-11-23
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 808

Inclusion Criteria

adult patients, >=18 years of age;
-cancer of the breast, with locally recurrent or metastatic disease
-HER2 positive (FISH-positive or IHC 3+);
-candidate for chemotherapy;
-ECOG performance status 0 or 1.

Exclusion Criteria

-anticancer therapy for metastatic breast cancer (except for one prior hormonal regimen);
-tyrosine kinase/HER inhibitors for breast cancer, except Herceptin used in the neoadjuvant or adjuvant
setting;
-systemic breast cancer treatment in neoadjuvant or adjuvant setting, with a disease-free interval from
completion of systemic treatment to metastatic diagnosis of <12 months;
-CNS metastases;
-clinically relevant cardiovascular disease.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
efficacy<br>Based on independent review facility evaluation

Secondary Outcome Measures

Name	Time	Method
safety<br>efficacy<br>Observation / inspection