Extension Study of pertuzumab

A SINGLE-ARM OPEN-LABEL MULTI-CENTRE EXTENSION STUDY OF PERTUZUMAB ADMINISTERED AS A SINGLE AGENT OR IN COMBINATION WITH OTHER ANTI-CANCER THERAPIES IN PATIENTS PREVIOUSLY ENROLLED IN A HOFFMANN-LA ROCHE-SPONSORED PERTUZUMAB STUDY

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224110

Enrollment

Registered

2018-10-24

Start date

2018-11-09

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

Solid Tumor

Interventions

investigational material(s) Generic name etc : Pertuzumab(RO4368451) INN of investigational material : Pertuzumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for I

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Informed consent - Prior eligibility for, and receiving pertuzumab as an investigational medicinal product in, a Roche-sponsored study (either as a single agent or in combination with other anti-cancer drugs used in the Parent study) at the time of the Parent study closure - Investigator's opinion that the patient continues to benefit from treatment

Exclusion criteria

Exclusion criteria: - Evidence of disease progression assessed according to Parent protocol before enrollment in to the extension study - More than 9 weeks between the last dose of pertuzumab in the Parent study and the first dose pertuzumab in the extension study

Design outcomes

Primary

Measure	Time frame
other To provide continued pertuzumab therapy to patients who were enrolled in a pertuzumab-study (the Parent study) and who continue to derive benefit from pertuzumab-based therapy.	—

Secondary

Measure	Time frame
safety efficacy observation, imaging	—

Countries

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

Outcome results

None listed

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