Clinical Evaluation of Lapatinib Administered with Capecitabine in Japanese Patients with ErbB2 Overexpressing Advanced or Metastatic Breast Cancer

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080220386

Enrollment

Registered

2007-04-27

Start date

2007-04-27

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

ErbB2 Overexpressing Advanced or Metastatic Breast Cancer

Interventions

investigational material(s) Generic name etc : Lapatinib|Capecitabine INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigat

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: - Signed informed consent - ErbB2 overexpressing advanced or metastatic breast cancer - Prior treatments with taxanes, anthracyclines, trastuzumab - No prior treatment with capecitabine - Female 20 years of age - ECOG Performance Status of 0 or 1 - Cardiac ejection fraction within the institutional range of normal - Adequate hematologic value, hepatic and renal function - Pregnant or lactating females - Conditions affecting the absorption of oral drugs - History of other malignancy - Known history of uncontrolled or symptomatic angina, arrhythmia or congestive heart failure - Known history or clinical evidence of leptomeningeal carcinomatosis - Known dihydropyrimidine dehydrogenase (DPD) deficiency

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Tolerability, Clinical Benefit Response Rate (CR, PR or SD for at least 6 months)	—

Outcome results

None listed

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