Veliparib + Lapatinib for Breast Cancer

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Must not be taking: Anti-arrhythmics, others

Disqualifiers: Brain metastases, Cardiac arrhythmia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 28 days per cycle

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness and safety of combining two drugs, Veliparib and Lapatinib, for treating metastatic triple-negative breast cancer. Veliparib remains under study, while Lapatinib (also known as Tykerb) has approval for another type of breast cancer. Participants with stage IV breast cancer that is HER-2 negative and who have tried other treatments might be suitable candidates. Eligible participants will receive both medications, not a placebo, and researchers will regularly monitor their response to the treatment. As an unphased trial, this study offers patients the chance to contribute to groundbreaking research that could lead to new treatment options.

Will I have to stop taking my current medications?

The trial requires that any chemotherapy treatment must be stopped at least 3 weeks before starting the study. However, the protocol does not specify about other medications, so it's best to discuss your current medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using Veliparib with Lapatinib is generally safe for people with advanced triple-negative breast cancer. Previous studies found that this combination has a manageable safety profile, meaning most side effects are known and can be effectively handled. Importantly, the studies did not identify any unexpected harmful effects. Lapatinib is already approved for another type of breast cancer, supporting its safety. While Veliparib is still under study, data so far suggests it is well-tolerated when used with Lapatinib. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of Veliparib and Lapatinib for treating breast cancer because it targets cancer cells in a unique way. Unlike most standard treatments that focus on hormone receptors or HER2 proteins, Veliparib is a PARP inhibitor, which works by preventing cancer cells from repairing their DNA, making them more susceptible to damage and death. Lapatinib, on the other hand, is a tyrosine kinase inhibitor that specifically targets the HER2 and EGFR pathways, which are involved in the growth and spread of cancer cells. The combination of these two drugs offers a novel approach by simultaneously disrupting multiple pathways critical for cancer cell survival, potentially leading to more effective outcomes.

What evidence suggests that the combination of Veliparib and Lapatinib could be effective for metastatic triple negative breast cancer?

Research has shown that using Veliparib and Lapatinib together, as studied in this trial, may help treat advanced triple-negative breast cancer. Early studies have found that this combination is generally safe, causing few serious side effects. These drugs have also shown promise in shrinking tumors. The FDA has already approved Lapatinib for another type of breast cancer, which supports its effectiveness. Veliparib remains under study, but early results are encouraging. ^{1 2 3 4 5}

Who Is on the Research Team?

Andres Forero, MD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My breast cancer is confirmed to be at stage IV.

Your platelet count is at least 100,000 per microliter.

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

Exclusion Criteria

My heart's electrical cycle is normal and I don't have conditions that could make it unsafe.

I have not used anthracyclines or taxanes for my cancer.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Veliparib and Lapatinib for 28-day cycles, with response evaluations every 8 weeks

28 days per cycle

Regular visits for drug administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 years

What Are the Treatments Tested in This Trial?

Interventions

• Lapatinib
• Veliparib

Trial Overview 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.

How Is the Trial Designed?

Group I: Combination of Veliparib + Lapatinib Experimental Treatment 1 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.

Lapatinib is already approved in United States, European Union for the following indications:

Approved in United States as Tykerb for:

• Advanced or metastatic breast cancer in combination with capecitabine for patients whose tumors overexpress HER2 and who have received prior therapy including an anthracycline, a taxane, and trastuzumab

Approved in European Union as Tyverb for:

• Advanced or metastatic breast cancer in combination with capecitabine for patients whose tumors overexpress HER2 and who have received prior therapy including an anthracycline, a taxane, and trastuzumab

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Breast Cancer Research Foundation of Alabama

Collaborator

Trials

2

Recruited

70+

AbbVie

Industry Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

GlaxoSmithKline

Industry Sponsor

Trials

4,834

Recruited

8,389,000+

Headquarters

London, UK

Known For

Vaccines & Medicines

Top Products

**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02158507

Pilot Study of Veliparib (ABT-888) and Lapatinib (Tykerb) in ... This study will evaluate the effectiveness and safety of the combination of two drugs, Veliparib and Lapatinib, given to participants with metastatic triple ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02158507?term=lapatinib%20and%20triple%20negative%20breast%20cancer&viewType=Table&rank=2

Pilot Study of Veliparib (ABT-888) and Lapatinib (Tykerb) in ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7934554/

An open-label, pilot study of veliparib and lapatinib in patients ... A first-in-human, pilot study of lapatinib and veliparib was conducted in metastatic TNBC (NCT02158507). The primary endpoint was safety and tolerability.

4. mycancergenome.org mycancergenome.org/content/clinical_trials/NCT02158507/

Clinical Trial: NCT02158507 - Breast Cancer This study will evaluate the effectiveness and safety of the combination of two drugs, Veliparib and Lapatinib, given to participants with ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33663560/

An open-label, pilot study of veliparib and lapatinib in ... Conclusions: Lapatinib plus veliparib therapy has a manageable safety profile and promising antitumor activity in advanced TNBC. Further ...