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Tyrosine Kinase Inhibitor

Lapatinib Ditosylate for Breast Cancer

Phase 2
Waitlist Available
Led By In A Kim
Research Sponsored by National Cancer Institute (NCI)
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 from randomization to last follow-up. mris occurred at baseline, 4 and 12 weeks post rt, then every 12 weeks thereafter until progression. maximum follow-up at time of analysis was 71.6 months.
Awards & highlights

Study Summary

This study is evaluating whether a combination of whole-brain radiation therapy and lapatinib ditosylate is more effective than either treatment alone.

Eligible Conditions
  • Breast Cancer
  • Brain Metastasis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization to last follow-up. mris occurred at baseline, 4 and 12 weeks post rt, then every 12 weeks thereafter until progression. maximum follow-up at time of analysis was 71.6 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to last follow-up. mris occurred at baseline, 4 and 12 weeks post rt, then every 12 weeks thereafter until progression. maximum follow-up at time of analysis was 71.6 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
Complete Response (CR) Rate in the Brain at 12 Weeks Post-radiation Therapy (RT) Using the RECIST 1.1 Criteria Based on Brain Magnetic Resonance Imaging (MRI)
Secondary outcome measures
Complete Response Rate in the Brain Using the World Health Organization (WHO)/Modified McDonald Criteria Based on Brain MRI
Brain
Frequency of Highest Treatment-related Adverse Event Per Participant
+7 more

Side effects data

From 2014 Phase 3 trial • 295 Patients • NCT00390455
62%
Diarrhea
55%
Fatigue
41%
Rash acneiform
35%
Nausea
27%
Hot flashes
16%
Vomiting
14%
Constipation
13%
Anorexia
13%
Headache
11%
Rash desquamating
6%
Aspartate aminotransferase increased
4%
Dyspnea
4%
Back pain
4%
Hemoglobin decreased
4%
Urinary tract infection
3%
Blood glucose increased
3%
Injection site reaction
3%
Alanine aminotransferase increased
2%
Alkaline phosphatase increased
2%
Bone pain
2%
Arthralgia
2%
Left ventricular failure
1%
Pneumonitis
1%
Pain of skin
1%
Alopecia
1%
Respiratory disorder
1%
Dry skin
1%
Eye pain
1%
Depression
1%
Blood bilirubin increased
1%
Pain in extremity
1%
Disease progression
1%
Serum sodium decreased
1%
Chest pain
1%
Hypoxia
1%
Serum potassium increased
1%
Anxiety
1%
Nail disorder
1%
Insomnia
1%
Pain
1%
Leukocyte count decreased
1%
Dehydration
1%
Skin disorder
1%
Sweating
1%
Hypertension
1%
Thrombosis
1%
Serum potassium decreased
1%
Developmental disturbance
1%
Ureteric obstruction
1%
Dyspnea (shortness of breath)
1%
Pruritus
1%
Abdominal pain
1%
Ascites
1%
Ill-defined disorder
1%
Creatinine increased
1%
Weight loss
1%
Cough
1%
Dizziness
1%
Peripheral sensory neuropathy
1%
Cardiac pain
1%
Skin ulceration
1%
Dyspepsia
1%
Gastrointestinal disorder
1%
Mucositis oral
1%
Bronchitis
1%
Nail infection
1%
Neck pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm I (Lapatinib)
Arm II (Placebo)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm B (lapatinib ditosylate, WBRT or SRS)Experimental Treatment4 Interventions
Patients undergo WBRT or SRS as in Arm A. Patients also receive lapatinib ditosylate PO QD for 6 weeks.
Group II: Arm A (WBRT or SRS)Experimental Treatment3 Interventions
Patients undergo WBRT 5 days a week for 3 weeks for a total of 15 treatments, or SRS for 1 treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Radiosurgery
2016
Completed Phase 2
~460
Lapatinib Ditosylate
2006
Completed Phase 3
~580
Whole-Brain Radiotherapy
2012
Completed Phase 2
~150

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,932,180 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
NRG OncologyOTHER
231 Previous Clinical Trials
100,709 Total Patients Enrolled
9 Trials studying Breast Cancer
11,638 Patients Enrolled for Breast Cancer
In A KimPrincipal InvestigatorNRG Oncology

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Whole-Brain Radiation Therapy or Stereotactic Radiosurgery With or Without Lapatinib Ditosylate in Treating Patients With Brain Metastasis From HER2-Positive Breast Cancer
2012. "Whole-Brain Radiation Therapy or Stereotactic Radiosurgery With or Without Lapatinib Ditosylate in Treating Patients With Brain Metastasis From HER2-Positive Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01622868.
~12 spots leftby Apr 2025
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