CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 40 enrolled / 40 target
Drug / intervention
Lapatinib +3 moredrug
Likely dose
Lapatinib 250 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01273610
NCT01273610Phase 2ActiveUpdate Overdue (0.2/mo)Completion was 100mo ago

Tolerability of the Combination of Lapatinib and Trastuzumab in Adults Age 60 or Older With HER2 Positive Locally Advanced or Metastatic Breast Cancer

City of Hope Medical Center·interventional·Posted Jan 10, 2011·Updated Jun 25, 2026

In Brief

A Phase 2 clinical trial evaluating Lapatinib, Trastuzumab, and 2 other interventions for Breast Neoplasms and 2 related conditions. Active but no longer recruiting, targeting 40 participants across 8 sites.

Signals

Enrollment appears stalled

Detailed Summary

This phase II trial studies the side effects and how well lapatinib ditosylate and trastuzumab work in treating older patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced) or to other parts of the body (metastatic). Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor to grow and spread. Others find tumor cells and help kill them or tumor cancer-killing substances to them. Giving lapatinib ditosylate together with trastuzumab may kill more tumor cells.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2Active
20112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 10, 2011
Enrollment StartApr 20, 2011
Primary CompletionFeb 22, 2018
Study CompletionApr 20, 2027
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 15.5 years ago

Arms & Interventions

Lapatinib and trastuzumabexperimental

Patients receive lapatinib ditosylate PO QD and trastuzumab IV once weekly OR once every 3 weeks. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Drug: LapatinibDrug: TrastuzumabOther: laboratory biomarker analysisOther: pharmacological study

Interventions

Lapatinibdrug

250 mg tablets

Trastuzumabdrug

Intravenous injection

laboratory biomarker analysisother

pharmacological studyother