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Monoclonal Antibodies

Lapatinib + Herceptin for Metastatic Breast Cancer

Phase 2

Waitlist Available

Research Sponsored by Nancy Lin, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 93 months

Awards & highlights

Study Summary

This trial is testing the effects of combining lapatinib with Herceptin for treating breast cancer that has spread outside the breast. They are also investigating if PET/CT scans could predict who would benefit from the treatment and studying genes and proteins in the tumor tissue that could make the cancer sensitive or resistant to Herceptin and the combination of Herceptin with lapatinib.

Who is the study for?

This trial is for adults with HER2-positive, metastatic breast cancer who have completed prior chemotherapy and radiation. They must be able to take oral meds, have a life expectancy over 12 weeks, and normal organ/marrow function. It's not for those with uncontrolled illnesses, on certain drugs, pregnant/breastfeeding women, or with active brain metastases.Check my eligibility

What is being tested?

The study tests the combination of lapatinib plus Herceptin in patients whose breast cancer has spread. It also examines if PET/CT scans can predict treatment benefits and analyzes tumor genes/proteins related to treatment sensitivity or resistance.See study design

What are the potential side effects?

Possible side effects include reactions similar to allergies due to compounds like lapatinib or other agents used in the study. The specific side effects are not listed but may relate to the typical profile of cancer therapies affecting organ functions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 93 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 93 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 93 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective Response Rate

Secondary outcome measures

3-Year Overall Survival

Clinical Benefit Rate

Median Time to Progression

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort 2Experimental Treatment2 Interventions

This cohort is made up of participants with one to two lines of chemotherapy for metastatic disease with at least one trastuzumab-containing regimen or patients who recurred within 12 months of adjuvant or neoadjuvant trastuzumab with up to one line of metastatic trastuzumab-based therapy 1000 mg daily Lapatinib 2 mg/kg weekly or 6 mg/kg every 3 week dose of trastuzumab

Group II: Cohort 1Experimental Treatment2 Interventions

This cohort is made up of participants without prior trastuzumab for MBC. Adjuvant or neoadjuvant trastuzumab was allowed, if the interval from trastuzumab completion to recurrence exceeded 1 year. 1000 mg daily Lapatinib 2 mg/kg weekly or 6 mg/kg every 3 week dose of trastuzumab

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Herceptin

2006

Completed Phase 3

~11180

Lapatinib

2006

Completed Phase 3

~3530

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Nancy Lin, MDLead Sponsor

3 Previous Clinical Trials

83 Total Patients Enrolled

2 Trials studying Breast Cancer

50 Patients Enrolled for Breast Cancer

GlaxoSmithKlineIndustry Sponsor

4,750 Previous Clinical Trials

8,067,365 Total Patients Enrolled

31 Trials studying Breast Cancer

2,326,217 Patients Enrolled for Breast Cancer

NovartisIndustry Sponsor

1,610 Previous Clinical Trials

2,719,183 Total Patients Enrolled

56 Trials studying Breast Cancer

21,101 Patients Enrolled for Breast Cancer

Media Library

Herceptin (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT00470704 — Phase 2

Breast Cancer Research Study Groups: Cohort 1, Cohort 2

Breast Cancer Clinical Trial 2023: Herceptin Highlights & Side Effects. Trial Name: NCT00470704 — Phase 2

Herceptin (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00470704 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has this medication been given the okay by the FDA?

"This is a Phase 2 trial, meaning that while there is some data supporting safety, none of it speaks to the efficacy of the treatment. Our team at Power has estimated the safety of this treatment to be a 2 on a scale from 1 to 3."

Answered by AI

What other purposes has this remedy been put to use for in the past?

"Breast cancer patients often receive this medication, but it is also sometimes given to postmenopausal women and those with a high risk of recurrence. Additionally, some advance directives include this treatment."

Answered by AI

How many individuals are being asked to participate in this clinical trial?

"Currently, this particular trial is not seeking patients. This study was first posted on May 14th, 2007 and was updated as recently as August 15th, 2022. There are 2698 trials for breast cancer and 216 for this treatment that are actively recruiting participants."

Answered by AI

Is this clinical trial widespread throughout the nation?

"Beth Israel Deaconess Medical Center in Boston, Massachusetts, Mayo Clinic in Rochester, Minnesota and Baylor College of Medicine in Houston, Texas are all active locations for this clinical trial. 9 other research centres across the country are also participating."

Answered by AI

Does this treatment have a good track record?

"This treatment was first researched in 1999 at Ospedale di Circolo e Fondazione Macchi. Since then, 471 completed studies have been undertaken. At the moment, there are 216 active trials; a majority of these are based in Boston, Massachusetts."

Answered by AI

Are there any patients needed for this clinical trial at the moment?

"Unfortunately, this research is not currently seeking new participants. The listing was first posted on May 14th, 2007 and edited most recently on August 15th, 2022. There are presently 2698 studies actively recruiting patients with breast cancer and 216 trials for this treatment actively enrolling patients."

Answered by AI

Recent research and studies

Journal of Clinical OncologyJournal

Phase II Study of Lapatinib in Combination with Trastuzumab in Patients with Human Epidermal Growth Factor Receptor 2–positive Metastatic Breast Cancer: Clinical Outcomes and Predictive Value of Early [<sup>18</sup>f]fluorodeoxyglucose Positron Emission Tomography Imaging (TBCRC 003)

Lin, Nancy U., Hao Guo, Jeffrey T. Yap, Ingrid A. Mayer, Carla I. Falkson, Timothy J. Hobday, E. Claire Dees, et al.. 2015. “Phase II Study of Lapatinib in Combination with Trastuzumab in Patients with Human Epidermal Growth Factor Receptor 2–positive Metastatic Breast Cancer: Clinical Outcomes and Predictive Value of Early [18f]fluorodeoxyglucose Positron Emission Tomography Imaging (TBCRC 003)”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2014.60.0353.

clinicaltrials.govStudy

Lapatinib in Combination With Trastuzumab in Patients With HER2-Positive, Metastatic Breast Cancer

Nancy Lin, MD 2007. "Lapatinib in Combination With Trastuzumab in Patients With HER2-Positive, Metastatic Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00470704.

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