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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ while on treatment, up to 4.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~while on treatment, up to 4.5 years
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 moreSide effects data
From 2020 Phase 1 & 2 trial • 88 Patients • NCT0201229682%
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%
Breast pain
6%
Alopecia
6%
Ear pain
6%
Flank pain
6%
Urinary incontinence
6%
White blood cell decreased
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
565 Previous Clinical Trials
1,921,420 Total Patients Enrolled
43 Trials studying Breast Cancer
6,649 Patients Enrolled for Breast Cancer
GlaxoSmithKlineIndustry Sponsor
4,750 Previous Clinical Trials
8,067,412 Total Patients Enrolled
32 Trials studying Breast Cancer
2,326,304 Patients Enrolled for Breast Cancer
NovartisIndustry Sponsor
1,610 Previous Clinical Trials
2,719,230 Total Patients Enrolled
57 Trials studying Breast Cancer
21,188 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a current heart condition.You have had allergic reactions to drugs similar to lapatinib or trastuzumab.I have an active liver or bile duct disease.I am able to get out of my bed or chair and move around.My heart pumps blood effectively.I cannot take medicine by mouth.You are expected to live for at least 12 weeks.Your AST and ALT levels in the blood are not more than 2.5 times the normal limit for the testing facility.I have brain metastases that are causing symptoms or are unstable.My breast cancer is advanced or has spread and is HER2 positive.I can swallow and keep down pills.I have previously been treated with lapatinib or trastuzumab.I agree to use birth control if I can have children or am a sexually active man.Your bilirubin levels are within the normal range for the hospital where the study is taking place.I am not currently on any experimental drugs or targeted cancer therapies.I have a condition that affects how my body absorbs nutrients.I can understand and am willing to sign the consent form.Your hemoglobin level must be 10 grams per deciliter or higher.Your neutrophil count is at least 1,500 per microliter of blood.You have enough platelets in your blood.My kidneys are working well enough (creatinine clearance >= 30 mL/min).I have had various treatments for cancer, including experimental ones.
Research Study Groups:
This trial has the following groups:- Group 1: Lapatinib and trastuzumab
Awards:
This trial has 3 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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.
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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