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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 am taking bisphosphonates, but my bone lesions can't be used to measure my cancer's progress.
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I have had no more than two treatments for my cancer since it spread, or I haven't had any but was treated with anthracyclines and taxanes before it spread.
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I finished my radiation therapy more than 21 days ago.
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My organ and bone marrow functions are normal.
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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 agree to a biopsy if my cancer has spread and it's safe to do so.
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I stopped chemotherapy 3 weeks ago.
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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
1,566 Previous Clinical Trials
2,268,364 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
946 Previous Clinical Trials
496,449 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants will be accepted in this clinical exploration?

"Unfortunately, recruitment for this research has already concluded. It was initially posted on September 1st 2014 and last reviewed on February 25th 2022. However, 2354 medical trials are presently recruiting participants with breast cancer while 42 studies related to the combination of Veliparib + Lapatinib currently require patients."

Answered by AI

What maladies can be alleviated with the Veliparib + Lapatinib combination therapy?

"Combination of Veliparib + Lapatinib is a viable solution for postmenopausal women, breast cancer patients and those seeking advance directives."

Answered by AI

Are there any preceding research examining the effects of Veliparib and Lapatinib administered together?

"Currently, 11 Combination of Veliparib + Lapatinib clinical trials are in Phase 3 with 42 ongoing studies. Though Lexington is the epicentre for these investigations, there exist 4371 sites globally conducting related research."

Answered by AI

Are investigators currently adding participants to this research endeavor?

"This medical trial is no longer accepting new patients. Initially posted on September 1st, 2014 and last updated February 25th 2022, participants should look elsewhere for clinical trials. At present, 2354 studies are recruiting individuals with a diagnosis of breast cancer while 42 separate investigations need volunteers to combine veliparib + lapatinib medications."

Answered by AI
~1 spots leftby Dec 2024