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Small Molecule Kinase Inhibitor

Lapatinib + Trastuzumab for HER2 Positive Breast Cancer

Phase 2
Waitlist Available
Led By Arti Hurria, MD
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status =< 2
Cardiac ejection fraction >= 50%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up while on treatment, up to 4.5 years
Awards & highlights

Study Summary

This trial is studying how well lapatinib ditosylate and trastuzumab work in treating older patients with HER2-positive breast cancer.

Who is the study for?
This trial is for adults aged 60 or older with HER2 positive breast cancer that's either locally advanced or has spread to other body parts. Participants must be able to take oral meds, have a life expectancy over 12 weeks, and an ECOG status of <=2. They should not have active heart disease, infections like HIV, unstable brain metastases, or conditions affecting medication absorption.Check my eligibility
What is being tested?
The study tests the combination of two drugs: Lapatinib and Trastuzumab in treating older patients with advanced HER2-positive breast cancer. It aims to see how well these drugs work together and what side effects they might cause when used in this age group.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system attacking normal cells (infusion reactions), liver issues, diarrhea, rashes on hands and feet (hand-foot syndrome), fatigue, nausea or vomiting. Heart function may also be affected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am able to get out of my bed or chair and move around.
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My heart pumps blood effectively.
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My breast cancer is advanced or has spread and is HER2 positive.
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I can swallow and keep down pills.
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My kidneys are working well enough (creatinine clearance >= 30 mL/min).

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~while on treatment, up to 4.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and while on treatment, up to 4.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent of Participants With Grade 3 or Higher Non-hematological Toxicities and Symptomatic Congestive Heart Failure
Secondary outcome measures
Median Overall Survival (OS)
Median Progression-free Survival (PFS)
Number of Participants With Tumor Response Using Response Evaluation Criteria in Solid Tumors (RECIST)
+1 more

Side effects data

From 2020 Phase 1 & 2 trial • 88 Patients • NCT02012296
82%
Fatigue
45%
Hot flashes
42%
Anorexia
39%
Constipation
27%
Pain
27%
Generalized muscle weakness
21%
Back pain
18%
Diarrhea
18%
Headache
18%
Hypertension
18%
Dizziness
18%
Nausea
15%
Weight loss
15%
Arthralgia
15%
Upper respiratory infection
12%
Abdominal pain
12%
Memory impairment
12%
Peripheral sensory neuropathy
12%
Hematuria
12%
Vomiting
12%
Fall
12%
Pain in extremity
12%
Urinary frequency
9%
Dyspnea
9%
Pelvic pain
9%
Hyperglycemia
9%
General disorders and administration site conditions - Other
9%
Anxiety
9%
Edema limbs
6%
White blood cell decreased
6%
Breast pain
6%
Alopecia
6%
Ear pain
6%
Flank pain
6%
Urinary incontinence
6%
Renal and urinary disorders - Other
6%
Investigations - Other
6%
Cystitis noninfective
6%
Fracture
6%
Hypokalemia
6%
Weight gain
6%
Watering eyes
6%
Paresthesia
6%
Neoplasms benign, malignant and unspecified
6%
Flu like symptoms
6%
Arthritis
6%
Bone pain
6%
Cough
6%
Urinary retention
3%
Neutrophil count decreased
3%
Small intestinal obstruction
3%
Depression
3%
Dyspepsia
3%
Platelet count decreased
3%
Confusion
3%
Ileus
3%
Skin and subcutaneous tissue disorders - Other
3%
Skin infection
3%
Non-cardiac chest pain
3%
Blurred vision
3%
Muscle weakness lower limb
3%
Insomnia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Enzalutamide, Mifepristone)
Treatment (Enzalutamide)
Not Randomized

Trial Design

1Treatment groups
Experimental Treatment
Group I: Lapatinib and trastuzumabExperimental Treatment4 Interventions
Patients receive lapatinib ditosylate PO QD and trastuzumab IV once weekly OR once every 3 weeks. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab
FDA approved
Lapatinib
FDA approved

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
570 Previous Clinical Trials
1,922,576 Total Patients Enrolled
43 Trials studying Breast Cancer
6,649 Patients Enrolled for Breast Cancer
GlaxoSmithKlineIndustry Sponsor
4,763 Previous Clinical Trials
8,104,727 Total Patients Enrolled
32 Trials studying Breast Cancer
2,326,304 Patients Enrolled for Breast Cancer
NovartisIndustry Sponsor
1,613 Previous Clinical Trials
2,721,219 Total Patients Enrolled
57 Trials studying Breast Cancer
21,179 Patients Enrolled for Breast Cancer

Media Library

Lapatinib (Small Molecule Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT01273610 — Phase 2
Breast Cancer Research Study Groups: Lapatinib and trastuzumab
Breast Cancer Clinical Trial 2023: Lapatinib Highlights & Side Effects. Trial Name: NCT01273610 — Phase 2
Lapatinib (Small Molecule Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01273610 — Phase 2

Frequently Asked Questions

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

What is the typical purpose of a pharmacological research?

"Breast cancer is typically managed with pharmacological study, and this approach can be beneficial for patients at high risk of recurrence, those who are post-menopause, or those following advance directives."

Answered by AI

Has the federal agency given its stamp of approval to this pharmaceutical research?

"Our team at Power rated the safety of this pharmacological study a 2, as it is currently in Phase 2; suggesting that there are some data points regarding its security but not efficacy."

Answered by AI

How many healthcare facilities are presently engaged in the research of this trial?

"The City of Hope Antelope Valley in Lancaster, California, the City of Hope Medical Center in Duarte, New york and the Roswell Park Cancer Institute in Buffalo, North carolina are all operating this trial. Plus there are 8 additional sites involved."

Answered by AI

Is this research endeavor currently recruiting participants?

"According to clinicaltrials.gov, this medical trial has already ceased recruiting participants; the study was initially posted on April 20th 2011 and last updated on July 6th 2022. However, there are still 2492 other studies actively requesting enrollees at this time."

Answered by AI

Could you outline other scholarly investigations into pharmaceuticals?

"Currently, 206 pharmacological studies are running with 55 in their final phase. Of these trials, several are located in Seattle, Washington; however there is a grand total of 14778 active clinical trial sites across the globe for this specific research endeavour."

Answered by AI

How many participants are currently enrolled in this research endeavor?

"Currently, this medical trial is not accepting patient enrolment. Initially advertised on April 20th 2011 and last updated July 6th 2022, it may be worth exploring the 2286 trials pertaining to breast cancer or 206 pharmacological studies currently recruiting members."

Answered by AI
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~3 spots leftby May 2025