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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 4 years
Awards & highlights

Study 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.

Timeline

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
Therapeutic procedure
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.

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,598 Previous Clinical Trials
2,286,739 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
977 Previous Clinical Trials
506,292 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