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Phase II clinical study of RG3502 in HER2 positive breast cancer patients

Phase II clinical study of RG3502 in HER2 positive patients with locally advanced/recurrent or metastatic breast cancer

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080221240
Enrollment
70
Registered
2010-09-13
Start date
2010-09-13
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

HER2 positive Breast Cancer

Interventions

Sponsors

Chugai Pharmaceutical Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: - Inoperable, locally advanced/recurrent or metastatic breast cancer - HER2-positive (FISH + or IHC 3+) - ECOG PS :0-2

Exclusion criteria

Exclusion criteria: - Clinically significant cardiac disease - Grade 3 or higher Hypersensitivity to trastuzumab

Design outcomes

Primary

MeasureTime frame
Response rate based on Efficacy Review Committee assessment RECIST ver. 1.1

Secondary

MeasureTime frame
Efficacy, Safety, Pharmacokinetics, Anti-RG3502 antibodies RECIST ver. 1.1, CTCAE ver. 4.0

Outcome results

None listed

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