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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%

Must not have

Active cardiac disease

Current active hepatic or biliary disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up while on treatment, up to 4.5 years

Awards & highlights

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).

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a current heart condition.

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I have an active liver or bile duct disease.

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I cannot take medicine by mouth.

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I have brain metastases that are causing symptoms or are unstable.

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I am not currently on any experimental drugs or targeted cancer therapies.

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I have a condition that affects how my body absorbs nutrients.

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

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

Dyspnea

Pelvic pain

Hyperglycemia

General disorders and administration site conditions - Other

Anxiety

Edema limbs

Weight gain

White blood cell decreased

Hypokalemia

Breast pain

Alopecia

Ear pain

Flank pain

Urinary incontinence

Renal and urinary disorders - Other

Investigations - Other

Cystitis noninfective

Fracture

Watering eyes

Paresthesia

Neoplasms benign, malignant and unspecified

Flu like symptoms

Arthritis

Bone pain

Cough

Urinary retention

Small intestinal obstruction

Neutrophil count decreased

Depression

Dyspepsia

Platelet count decreased

Confusion

Ileus

Skin and subcutaneous tissue disorders - Other

Skin infection

Non-cardiac chest pain

Blurred vision

Muscle weakness lower limb

Insomnia

100%

80%

60%

40%

20%

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

0 / 11Eligibility criteria met