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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

No Placebo-Only Group

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Therapeutic procedure

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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