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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
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.
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.
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Objective Response Rate
Secondary study objectives
3-Year Overall Survival
Clinical Benefit Rate
Median Time to Progression
+2 moreTrial 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
~11520
Lapatinib
2006
Completed Phase 3
~3530
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Who is running the clinical trial?
Nancy Lin, MDLead Sponsor
3 Previous Clinical Trials
69 Total Patients Enrolled
2 Trials studying Breast Cancer
50 Patients Enrolled for Breast Cancer
GlaxoSmithKlineIndustry Sponsor
4,788 Previous Clinical Trials
8,176,720 Total Patients Enrolled
31 Trials studying Breast Cancer
2,326,217 Patients Enrolled for Breast Cancer
NovartisIndustry Sponsor
1,624 Previous Clinical Trials
2,723,695 Total Patients Enrolled
56 Trials studying Breast Cancer
21,058 Patients Enrolled for Breast Cancer
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are able to perform daily activities without difficulty.You have brain tumors that are currently getting worse.You are willing to have a tissue sample taken from your recurrent or spreading disease for research purposes.Your organs and bone marrow are working normally, as described in the study plan.You have a specific type of breast cancer that shows high levels of HER2 protein or gene amplification.You have confirmed invasive breast cancer that has spread to other parts of the body.You have had up to two rounds of chemotherapy for advanced breast cancer, and you have not been treated with lapatinib or other HER2-targeted therapy except for trastuzumab.You have a serious problem absorbing nutrients from food.You have had allergic reactions to drugs similar to lapatinib.You are expected to live for more than 12 weeks.Your heart's pumping ability, as measured by a MUGA scan or echocardiogram, is 50% or higher.You have at least one specific spot of disease that can be accurately measured.You have not had chemotherapy or certain targeted therapies for advanced breast cancer before.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1
- Group 2: Cohort 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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