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

23 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will evaluate the effectiveness and safety of the combination of two drugs, Veliparib and Lapatinib, given to participants with metastatic triple negative breast cancer that have undergone previous treatment. Veliparib is an investigational drug and has not been approved by the FDA while Lapatinib has been approved by the FDA for another type of breast cancer. All eligible participants will receive the study medications and not a placebo.

Research Team

Andres Forero, MD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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