23 Participants Needed

Veliparib + Lapatinib for Breast Cancer

Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: University of Alabama at Birmingham
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

AF

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.
See 20 more

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.
See 10 more

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?
1Treatment groups
Experimental Treatment
Group I: Combination of Veliparib + LapatinibExperimental Treatment1 Intervention

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

🇺🇸
Approved in United States as Tykerb for:
🇪🇺
Approved in European Union as Tyverb for:

Find a Clinic Near You

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 profile image

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 profile image

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron profile image

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

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