Assessment of safety on trastuzumab with varied dilution solution volume in HER2 positive breast cancer

Assessment of safety on trastuzumab with varied dilution solution volume in HER2 positive breast cancer - Assessment of safety on trastuzumab with varied dilution solution volume in HER2 positive breast cancer(KBCSG03)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008983

Enrollment

Registered

2012-09-26

Start date

2012-09-26

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

level 1 After the first trastuzumab treatment: 2mg/kg of trastuzumab with 100 ml saline solution administered intravenously over 30 minutes level 2 After the first trastuzumab treatment: 6mg/kg of

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1) 20 years of age or more 2) HER2 overexpression confirmed by IHC or FISH 3) recieving neo-adjuvant or adjuvant therapy with trastuzumab 4) recieving mono trastuzumab treatment 5) Baseline left ventricular ejection fraction; above 50% based on echocardiography or MUGA scan in last 6)Signed informed consent

Exclusion criteria

Exclusion criteria: 1) with severe allergy to trastuzumab 2) Judjed ineligible based on physicians' decision

Design outcomes

Primary

Measure	Time frame
To evaluate MTD and RD	—

Secondary

Measure	Time frame
serious incidence of infusion reaction after the first treatment with trastuzumab	—

Countries

Japan

Contacts

Public ContactNorihiko Sengoku

Kitasato University School of Medicine Department of Surgery

042-778-8111

Outcome results

None listed

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