Phase 1b study of U3-1287 in combination with trastuzumab plus paclitaxel in patients with HER2-positive metastatic breast cancer (MBC)

Status

Unknown

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221730

Enrollment

Registered

2012-03-02

Start date

2012-03-02

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 MBC

Interventions

investigational material(s) Generic name etc : U3-1287 INN of investigational material : Patritumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: - Histologically or cytologically confirmed invasive carcinoma of the breast with metastatic disease - Documented HER2-positive disease - ECOG performance status: 0 or 1

Exclusion criteria

Exclusion criteria: - Has history of anti-HER3 therapy - Total dose of anthracyclines >= 360mg/m2 in prior treatment - Patients with active other malignancies - Has history or complication of interstitial lung disease by radiographic examination - Left ventricular ejection fraction(LVEF) = 10% from base line on prior trastuzumab therapy and the decline to <55% - Has brain metastasis with clinical symptoms or requiring treatment - Has history of serious drug hypersensitivity reaction such as anaphylaxis

Design outcomes

Primary

Measure	Time frame
Safety and pharmacokinetics NCI-CTC ver. 4.03	—

Secondary

Measure	Time frame
- Incidence of anti-U3-1287 antibody - Preliminary assessment of anti-tumor activity of U3-1287 - Exploratory study on U3-1287-related biomarker RECIST ver. 1.1	—

Outcome results

None listed

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