Lapatinib + Trastuzumab for HER2 Positive Breast Cancer

Recruiting in Palo Alto (17 mi)

+7 other locations

Overseen byDaneng Li, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: City of Hope Medical Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Daneng Li, MD

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

This trial is for adults aged 60 or older with HER2 positive breast cancer that's either locally advanced or has spread to other body parts. Participants must be able to take oral meds, have a life expectancy over 12 weeks, and an ECOG status of <=2. They should not have active heart disease, infections like HIV, unstable brain metastases, or conditions affecting medication absorption.

Inclusion Criteria

I am able to get out of my bed or chair and move around.

My heart pumps blood effectively.

You are expected to live for at least 12 weeks.

See 12 more

Exclusion Criteria

Concomitant medications listed are prohibited

Ongoing or active infection (including human immunodeficiency virus [HIV]) or psychiatric illness/social situations that would limit compliance with study requirements

I have a current heart condition.

See 6 more

Treatment Details

Interventions

Lapatinib (Small Molecule Kinase Inhibitor)
Trastuzumab (Monoclonal Antibodies)

Trial OverviewThe study tests the combination of two drugs: Lapatinib and Trastuzumab in treating older patients with advanced HER2-positive breast cancer. It aims to see how well these drugs work together and what side effects they might cause when used in this age group.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Lapatinib and trastuzumabExperimental Treatment4 Interventions

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.