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Small Molecule Kinase Inhibitor
Lapatinib + Trastuzumab for Breast Cancer (HELEX Trial)
Phase 2
Waitlist Available
Led By Mothaffar Rimawi, MD
Research Sponsored by Baylor Breast Care Center
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 12 or 24 week depending the arm assignment
Awards & highlights
No Placebo-Only Group
Summary
This trial demonstrates that targeted therapies can be very successful in reducing tumor recurrences and mortality in early breast cancer. However, there is still a need for new strategies to overcome resistance to these treatments.
Who is the study for?
This trial is for women over 18 with advanced breast cancer larger than 2 cm, HER2 positive, and no Stage IV disease. They must have a life expectancy over 6 months, good performance status, normal organ function tests, and no other cancers or severe illnesses in the last five years. Participants cannot be pregnant and must agree to use contraception.
What is being tested?
The study examines the effectiveness of combining Trastuzumab (Herceptin), Lapatinib, and possibly Letrozole as treatments for breast cancer that overexpresses HER2. It aims to overcome resistance to therapy by targeting different molecular mechanisms within the tumor cells.
What are the potential side effects?
Potential side effects may include diarrhea, liver issues, rash or dry skin from Lapatinib; heart problems like reduced heart function from Trastuzumab; and joint pain or hot flashes from Letrozole.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 or 24 week depending the arm assignment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 or 24 week depending the arm assignment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Pathologic Complete Response
Secondary study objectives
Number of Participants With Adverse Events
Total Pathologic Complete Response
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: 24-week armExperimental Treatment3 Interventions
Participants will receive 24-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.
Group II: 12-week armActive Control3 Interventions
Participants will receive 12-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab
2014
Completed Phase 4
~5190
Letrozole
2002
Completed Phase 4
~3590
Lapatinib
2006
Completed Phase 3
~3530
Find a Location
Who is running the clinical trial?
Baylor Breast Care CenterLead Sponsor
15 Previous Clinical Trials
625 Total Patients Enrolled
11 Trials studying Breast Cancer
558 Patients Enrolled for Breast Cancer
Translational Breast Cancer Research ConsortiumOTHER
25 Previous Clinical Trials
2,847 Total Patients Enrolled
14 Trials studying Breast Cancer
1,865 Patients Enrolled for Breast Cancer
GlaxoSmithKlineIndustry Sponsor
4,806 Previous Clinical Trials
8,380,721 Total Patients Enrolled
31 Trials studying Breast Cancer
2,326,141 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a serious, long-term health condition.You are in good enough health and expected to live for at least 6 more months.You have a condition that affects how your body absorbs nutrients, or a significant disease that affects your stomach or intestines. If you have ulcerative colitis, you will also be excluded.You have not had any other cancers, except for certain types of skin and cervical cancers that were treated and are not a current concern.You have active, infectious Hepatitis B, Hepatitis C, or HIV.If you could become pregnant, you must have a negative pregnancy test within 7 days before starting the study drug.You have cancer in both breasts.You have severe or uncontrolled high blood pressure, or a history of serious heart problems.You have a heart condition called cardiomyopathy or your heart's pumping function is less than 50%.You have had a previous invasive breast cancer on the same side, or a non-invasive breast cancer, and now have a new cancer.You have been treated for breast cancer in the past five years, including surgery, chemotherapy, hormone therapy, or targeted therapy.You have breast cancer that is larger than 3 cm, or larger than 2 cm with signs of spread to the nearby lymph nodes. If the tumor is smaller than 3 cm, the size will be checked using imaging to see if it meets the size criteria.You must have a specific type of breast cancer with high levels of a protein called HER2, as confirmed by a lab test.Your kidney and liver function tests should be close to the normal range, not more than 1.5 times higher than the usual limit.You should not have cancer that has spread to the brain or the tissues surrounding the brain, or any other advanced stage of cancer.
Research Study Groups:
This trial has the following groups:- Group 1: 24-week arm
- Group 2: 12-week arm
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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