A Phase II Trial of Lapatinib and Trastuzumab in Patients with Heavily Pretreated Metastatic Breast Cancer

A Phase II Trial of Lapatinib and Trastuzumab in Patients with Heavily Pretreated Metastatic Breast Cancer - A Phase II Trial of Lapatinib and Trastuzumab in Patients with Heavily Pretreated Metastatic Breast Cancer

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002651

Enrollment

Registered

2009-11-10

Start date

2009-12-01

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 patients treted with multiple cytotoxic agent including trastuzumab

Interventions

Lapatinib Trastuzumab

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: a) HER2 positive advanced breast cancer b) Anthracycline, taxanes, fluorouracil, vincaalkanoid, and trastzumab pretreated c) PS 0-2 d) New York Heart Association classification<II e) Target lesion required by RECIST

Exclusion criteria

Exclusion criteria: a) Lapatinib pretreated b) Ejectoon fraction <50%

Design outcomes

Primary

Measure	Time frame
response rate	—

Secondary

Measure	Time frame
overall survival, progression free survival, adverse event	—

Countries

Japan

Contacts

Public ContactKenji Hashimoto

National Cancer Center Hospital Breast and Medical Oncology Division

03-3542-2511

Outcome results

None listed

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