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Tyrosine Kinase Inhibitor

Veliparib + Lapatinib for Breast Cancer

N/A

Waitlist Available

Led By Andres Forero, MD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient must have pathologically documented stage IV breast cancer.

Patients must have recovered from all reversible toxicities related to prior therapy before beginning protocol treatment and may not have any pre-existing treatment-related toxicities higher than Grade 2. Patients must have less than Grade 2 pre-existing peripheral neuropathy.

Must not have

No prior use of anthracyclines and taxanes for metastatic disease or in the adjuvant or neoadjuvant setting.

Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, history of recent myocardial infarction, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease or psychiatric illness/social situations that would limit compliance with study requirements.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 4 years

Awards & highlights

Summary

This trial will study the effectiveness of two drugs, Veliparib and Lapatinib, for treating metastatic triple negative breast cancer.

Who is the study for?

This trial is for adults over 19 with stage IV triple negative breast cancer, who've had prior treatments but no more than two in the metastatic setting. They must have measurable disease, normal organ/marrow function, and a life expectancy of over 12 weeks. Not eligible if they have certain heart conditions, brain metastases that are active or recent serious illnesses.Check my eligibility

What is being tested?

The study tests Veliparib combined with Lapatinib on patients with advanced breast cancer to assess effectiveness and safety. Veliparib is experimental while Lapatinib is FDA-approved for another type. There's no placebo; all participants receive the drugs.See study design

What are the potential side effects?

Potential side effects aren't specified here but may include typical reactions to cancer medications such as nausea, fatigue, blood count changes, liver function alterations, and possibly heart or nerve issues due to the nature of these drugs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My breast cancer is confirmed to be at stage IV.

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I have recovered from side effects of previous treatments and do not have severe nerve damage.

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I finished my radiation therapy more than 21 days ago.

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My kidney function, measured by creatinine levels or clearance, is within the required range.

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I am 19 years old or older.

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I can take care of myself but might not be able to do heavy physical work.

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My doctor expects me to live more than 12 weeks.

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My tumor is not driven by HER-2, estrogen, or progesterone, and I don't have BRCA mutations.

Exclusion Criteria

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

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I have not used anthracyclines or taxanes for my cancer.

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I do not have any severe illnesses that could interfere with the study.

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I have cancer spread to my brain but also have a measurable tumor outside my brain.

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I have not had cancer, except for certain skin cancers, in the last 5 years.

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I am able to understand and give informed consent.

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I have seizures that are not controlled by medication.

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I have a history of HIV or Hepatitis B.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 4 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

Number of subjects experiencing study-related toxicities when taking Veliparib in Combination with Lapatinib

Secondary outcome measures

Therapeutic procedure

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Combination of Veliparib + LapatinibExperimental Treatment1 Intervention

Lapatinib will be administered as a tablet at a dosage of 1250 mg/day continuously for 28 days starting on Day 1 of each cycle. Veliparib will be administered as a capsule at a dosage of 200 mg every 12 hours for 28 days starting on Day 2 of each cycle. A cycle of therapy is defined as 28 days. Treatment is administered on an outpatient basis. Patient response will be evaluated every 8 weeks according to the current Response Evaluation Criteria in Solid Tumors (RECIST) guidelines and performance of relevant scans and/or x-rays.

0 / 15Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,599 Previous Clinical Trials

2,287,897 Total Patients Enrolled

32 Trials studying Breast Cancer

4,491 Patients Enrolled for Breast Cancer

Breast Cancer Research Foundation of AlabamaUNKNOWN

1 Previous Clinical Trials

40 Total Patients Enrolled

AbbVieIndustry Sponsor

983 Previous Clinical Trials

509,338 Total Patients Enrolled

7 Trials studying Breast Cancer

454 Patients Enrolled for Breast Cancer

Media Library

Lapatinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02158507 — N/A

Breast Cancer Research Study Groups: Combination of Veliparib + Lapatinib

Breast Cancer Clinical Trial 2023: Lapatinib Highlights & Side Effects. Trial Name: NCT02158507 — N/A

Lapatinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02158507 — N/A

~1 spots leftby Dec 2024

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