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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

HELEX Trial 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.Check my eligibility
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.See study design
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.

HELEX Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 or 24 week depending the arm assignment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 or 24 week depending the arm assignment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pathologic Complete Response
Secondary outcome measures
Clinical Response
Number of Participants With Adverse Events
Total Pathologic Complete Response

HELEX 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
~3240
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
22 Previous Clinical Trials
2,229 Total Patients Enrolled
12 Trials studying Breast Cancer
1,447 Patients Enrolled for Breast Cancer
GlaxoSmithKlineIndustry Sponsor
4,758 Previous Clinical Trials
8,104,002 Total Patients Enrolled
31 Trials studying Breast Cancer
2,326,176 Patients Enrolled for Breast Cancer

Media Library

Lapatinib (Small Molecule Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT00999804 — Phase 2
Breast Cancer Research Study Groups: 24-week arm, 12-week arm
Breast Cancer Clinical Trial 2023: Lapatinib Highlights & Side Effects. Trial Name: NCT00999804 — Phase 2
Lapatinib (Small Molecule Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00999804 — Phase 2

Frequently Asked Questions

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

Can Lapatinib be administered without fear of adverse consequences?

"Lapatinib has been assigned a safety evaluation of 2, as its efficacy is yet to be confirmed but the available data does suggest it carries some level of security."

Answered by AI

How has Lapatinib been employed to treat certain medical conditions?

"Lapatinib is a drug that has seen much success against the BRCA1 gene-related illnesses, such as breast cancer and inflammatory breast cancer (IBC). It can also be employed in tamoxifen treatment."

Answered by AI

Are there any opportunities to participate in this clinical experiment currently?

"According to clinicaltrials.gov, this research trial is not currently recruiting patients. The study began on October 1st 2011 and was last edited on May 15th 2022. There are numerous other medical trials actively looking for volunteers at the present time: a total of 2940 in fact."

Answered by AI

Could you provide information on other research initiatives regarding Lapatinib?

"Currently, there are 340 active trials investigating the usage of Lapatinib. Out of those studies, 91 have reached Phase 3. Notably, though Seattle is a major centre for this drug's research, over 25 thousand medical centres across the world are administering clinical tests for Lapatinib."

Answered by AI

How many sites are facilitating this experiment?

"This research trial is taking place at Duke University in Durham, North carolina and Indiana University in Indianapolis, Indiana. Other locations include Vanderbilt University Medical Center in Nashville, Tennessee as well as 8 other sites."

Answered by AI

How many individuals have been accepted to partake in this medical trial?

"Unfortunately, this clinical trial has already closed its recruitment period. Initially posted on October 1st 2011 and last updated on May 15th 2022, it is no longer enrolling patients. Nevertheless, 2600 trials related to breast cancer are still recruiting participants and 340 studies involving Lapatinib remain open for enrolment."

Answered by AI
~9 spots leftby May 2025