Brain Metastases In ErbB2-Positive Breast Cancer

Phase 2

• Conditions: Metastatic Breast Cancer

• Registration Number: JPRN-jRCT2080220279
• Lead Sponsor: GlaxoSmithKline K.K.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-07-14
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- 18 Years and above
- ErbB2(HER2)overexpressing breast cancer.
- Brain lesion(s) which are progressing.
- Prior treatment of brain metastases with Whole Brain Radiotherapy (WBR) and/or Stereotactic Radiosurgery (SRS).
- Prior treatment with Trastuzumab (Herceptin), either alone or in combination with chemotherapy.
- Cardiac ejection fraction (LVEF) within the institutional range of normal as measured by Echocardiogram.
- Adequate liver, kidney and bone marrow function.

- Pregnant or lactating females.
- Conditions that would effect the absorption of an oral drug.
- History of immediate or delayed hypersensitivity reaction to gadolinium contrast agents.
- Pre-existing severe cerebral vascular disease, such as stroke involving a major vessel.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the response to lapatinib in patients with progressive brain metastases from ErbB2-overexpressing breast cancer, and Safety.