CLEOPATRA

A randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of Herceptin + docetaxel + pertuzumab versus Herceptin + docetaxel + placebo in previously untreated HER2-positive metastatic breast cancer

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080220775

Enrollment

800

Registered

2009-07-22

Start date

2009-07-18

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Interventions

investigational material(s) Generic name etc : R1273(pertuzumab) INN of investigational material : Pertuzumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Inves

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
efficacy Based on independent review facility evaluation	—

Secondary

Measure	Time frame
safety efficacy Observation / inspection	—

Countries

Asia except Japan, Europe, Japan, North America, South America

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026