Metastatic Triple Negative Breast CancerNCT02158507
Pilot Study of Veliparib (ABT-888) and Lapatinib (Tykerb) in Patients With Metastatic, Triple Negative Breast Cancer
A study testing Combination of Veliparib + Lapatinib in people with Metastatic Triple Negative Breast Cancer, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Metastatic Triple Negative Breast Cancer
- What is being tested?
- Combination of Veliparib + Lapatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2014to 22 Jul 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must pathologically documented stage IV breast cancer.
- Tumor must be HER-2 negative, and estrogen and progesterone receptors negative. Patients with BRCA 1 or 2 mutations will not be included.
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension.
- Biopsy of a metastatic lesion is not required for protocol entry but all patients with reasonably accessible lesions must agree to biopsy. (Lung and brain metastasis will not be biopsied.) Patients with no reasonably accessible lesions can be enrolled in the trial.
- Prior Therapy:
- No more than two regimens in the metastatic setting as long as patients have adequate performance status. Patients with no prior chemotherapy for metastatic disease may be included in the trial if they received anthracyclines and taxanes in the adjuvant or neoadjuvant settings. Chemotherapy naïve patients with metastatic disease must have failed anthracyclines and taxanes.
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- Chemotherapy treatment prior to enrollment must be discontinued for at least 3 weeks prior to study entry.
- Patients must have completed radiation therapy at least 21 days prior to beginning protocol treatment.
- Patients must have recovered from all reversible toxicities related to prior therapy before beginning protocol treatment and may not have an pre- existing treatment-related toxicities higher than Grade 2. Patients must have less than Grade 2 pre-existing peripheral neuropathy.
- Patients may receive bisphosphonates. However, if used, bone lesions may not be used for progression or response.
- At least 19 years of age.
- Life expectancy of >12 weeks.
- Performance status according to Eastern Cooperative Oncology Group (ECOG) is less than or equal to 2.
- Patients must have normal organ and marrow function as defined below:
- Absolute neutrophil count: greater than or equal to 1,000/uL
- Hemoglobin: greater than or equal to 9 mg/dL
- Platelets: greater than or equal to 100,000/uL
- Total bilirubin: less than or equal to 1.5 times the institutional upper limit of normal
- AST (SGOT)/ALT (SGPT): less than or equal to 2.5 times the institutional upper limit of normal without liver metastases OR less than or equal to 5 times the institutional upper limit of normal if documented liver metastases
- Creatinine: less than or equal to 1.5 mg/dL OR calculated creatinine clearance greater than or equal to 40 mL/min (calculated using the modified Cockcroft and Gault method).
- Ability to understand and the willingness to sign a written informed consent document.
- Use of an effective means of contraception in subjects of child-bearing potential.
- Negative serum or urine beta-HCG (human chorionic gonadotropin) pregnancy test at screening for patients with childbearing potential.
- Ejection fraction must be 50%.
Who cannot join
- Patients may not be receiving any other investigational agents.
- No prior use of anthracyclines and taxanes for metastatic disease or in the adjuvant or neoadjuvant setting.
- Metastatic lesions identifiable only by PET.
- QTc (corrected QT) >470 msec. Excluded are patients who may develop prolongation of QTc. These conditions include patients with hypokalemia or hypomagnesemia, congenital long QT syndrome, patients taking anti- arrhythmic medicines or other medicinal products that lead to QT prolongation, and cumulative high-dose anthracycline therapy.
- Patients may not be receiving concurrent chemotherapy for treatment of metastatic disease.
- Active brain metastases: evidence of progression less than or equal to 3 months after local therapy. (Patients should be asymptomatic and off corticosteroids and anticonvulsants for at least 3 months prior to study entry).
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- Patients with brain metastases must have at least one site of measurable disease outside of the central nervous system.
- 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.
- Uncontrolled seizure disorder.
- Pregnant or lactating women are excluded. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother, breastfeeding should be discontinued if the mother is treated. These potential risks may also apply to other agents used in this study.
- A prior invasive malignant disease within five years except for skin cancer (squamous cell or basal cell carcinoma).
- Patients with known history of HIV or Hepatitis B because of potential for added toxicity from treatment regimen.
- Dementia or altered mental status that would prohibit the understanding of informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: An Open Label, Pilot Study of Veliparib (ABT-888) and Lapatinib (Tykerb) in Patients With Metastatic, Triple Negative (ER, PR, and HER-2 Negative) Breast Cancer
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.
Read the detailed description
Breast cancer is the most commonly diagnosed cancer in American women. Metastatic breast cancer remains incurable partially due to the lack of targeted therapy for selected subsets of patients. There are five distinct subsets of breast cancer with unique biological profiles. Triple negative breast cancer (TNBC) is a subset with special clinical interest because of its significant percentage of occurrence (10-20% of all breast cancer diagnoses) and its poor prognosis. With no defined targeted therapy to date, this study seeks to investigate a therapeutic strategy based on specific molecular abnormalities in the tumor cells of TNBC.
- Conditions
- Metastatic Triple Negative Breast Cancer
- Being tested
- Combination of Veliparib + Lapatinib
- Keywords
- triple negative breast cancer (TNBC), Veliparib, Lapatinib, estrogen receptor negative, progesterone receptor negative, (HER-2-Neu) negative
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination of Veliparib + LapatinibDrug
Also called Veliparib (ABT-888), Lapatinib (Tykerb)
Treatment cannot be in administered conjunction with other chemotherapy, targeted therapy, radiation therapy, or other investigational drugs.
| Study group | Role | What they receive |
|---|---|---|
| Combination of Veliparib + Lapatinib | Experimental | 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. Receives: Drug: Combination of Veliparib + Lapatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Experiencing Study-related Toxicities When Taking Veliparib in Combination With Lapatinib
Drug related toxicities for the safety analysis are defined as: a) any grade 3 or 4 non-hematologic toxicity except alopecia and nausea which is not refractory to anti-emetics; b) failure to recover to baseline (except alopecia) after delaying the next dose by more than 14 days; c) grade 3 or 4 neutropenia complicated by fever equal to or greater than 38.50 degrees C or infection, or grade 4 neutropenia of a least 7 days duration; or d) grade 4 thrombocytopenia, or grade 3 thrombocytopenia complicated by hemorrhage. Toxicity evaluation of the patients enrolled in the trial will be done using the NCI Common Toxicity Criteria.
Measured: baseline to 4 years
Secondary outcomes (5)
Number of Subjects With Objective Response Rate (ORR) at 4 Years Post Baseline (Complete Responses [CRs] Plus Partial Responses [PRs]
Complete responses plus partial responses will be included as indicators of an objective response rates. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Measured: 4 years post baseline
Number of Subjects With Progression Free Survival (PFS) at 4 Years After Start of Study.
Number of subjects who survive to 4 years with no disease progression. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Measured: Baseline to 4 years
DNA Methylation and RNA Transcriptome Will be Evaluated Before and After Therapy; Baseline Pattern Will be Compared With the Post Treatment Pattern to Identify Markers of Response or Resistance.
Analysis of the genomic data from tumors may allow us to identify if there is a gene or groups of genes that will be able to predict response or resistance to the research combination; in order to conduct the genomic evaluation it is necessary to correlate with clinical response. In addition, we will conduct IHC studies in order to analyze markers that will indicate us if the combination of the research agents inhibit the targets for which they were designed (H2AX, BRCA and EGFR); this data needs to be correlated with clinical data to see if the lab evaluations correlate with the response of the patient. In addition, we will evaluate by IHC markers of apoptosis that will indicate us if the combination of research agents was cytotoxic against the tumor cells ; this data needs to be correlated with clinical data to see if the lab evaluations correlate with the response of the patient.
Measured: Within 4 weeks of baseline (treatment initiation)
Measure Numbers of Circulating Tumor Cells Before and After Therapy
Circulating tumor cells will be measured before and after therapy and will indicate if the therapy is active against the tumor; a decrease in the number of the circulating tumor cells will indicate effectiveness of the combination.
Measured: Before and after Cycle 1 (up to 28 days)
Peak Plasma Concentration of Veliparib and Palatinib When Given in Combination.
Blood samples for the first day will be collected 5 minutes before the start of therapy, 30 and 60 minutes after the first dose of Lapatinib and then 2, 4, 6, 8, and 24 hours after the start of Lapatinib. On day 2, Lapatinib and Veliparib will be given and samples will be taken 30 and 60 minutes after the first dose and then at 2, 4, 6, 8, and 24 hours. Additional blood samples will be taken on day 3, before the third day dose of the combined study drugs. The same schema will be followed on days 8, 9, and 10.
Each pharmacokinetic variable will be divided by dose groups for descriptive statistical analyses (mean, standard deviation, coefficient of variation, geometric mean, median, minimum and maximum per dose group).
Measured: Up to day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2014 (estimated)
- Study start4 Sep 2014
- Primary completion22 Jul 2021
- Study completion22 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Triple Negative Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Breast Cancer Research Foundation of Alabama, GlaxoSmithKline, AbbVie
- Responsible party
- Principal investigator, Erica Stringer-Reasor, University of Alabama at Birmingham
- Investigators
- Andres Forero, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02158507
- Sponsor's protocol ID
- F131219003 (UAB 1372)
- Other IDs
- 000504723
- Status last verified
- Dec 2025
- First submitted
- 29 May 2014
- Last updated
- 22 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Stringer-Reasor EM, May JE, Olariu E, Caterinicchia V, Li Y, Chen D, Della Manna DL, Rocque GB, Vaklavas C, Falkson CI, Nabell LM, Acosta EP, Forero-Torres A, Yang ES. An open-label, pilot study of veliparib and lapatinib in patients with metastatic, triple-negative breast cancer. Breast Cancer Res. 2021 Mar 4;23(1):30. doi: 10.1186/s13058-021-01408-9.
PubMed 33663560
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Pilot Study of Veliparib (ABT-888) and Lapatinib (Tykerb) in Patients With Metastatic, Triple Negative (ER, PR, and HER-2 Negative) Breast Cancer
- ClinicalTrials.gov ID
- NCT02158507
- Acronym / sponsor ID
- F131219003 (UAB 1372)
- Conditions
- Metastatic Triple Negative Breast Cancer
- Keywords
- triple negative breast cancer (TNBC), Veliparib, Lapatinib, estrogen receptor negative, progesterone receptor negative, (HER-2-Neu) negative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Breast Cancer Research Foundation of Alabama, GlaxoSmithKline, AbbVie
- Study start
- 4 Sep 2014 (actual)
- Primary completion
- 22 Jul 2021 (actual)
- Study completion
- 22 Jul 2021 (actual)
- First posted
- 9 Jun 2014 (estimated)
- Results
- Posted 22 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Breast cancer is the most commonly diagnosed cancer in American women. Metastatic breast cancer remains incurable partially due to the lack of targeted therapy for selected subsets of patients. There are five distinct subsets of breast cancer with unique biological profiles. Triple negative breast cancer (TNBC) is a subset with special clinical interest because of its significant percentage of occurrence (10-20% of all breast cancer diagnoses) and its poor prognosis. With no defined targeted therapy to date, this study seeks to investigate a therapeutic strategy based on specific molecular abnormalities in the tumor cells of TNBC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combination of Veliparib + Lapatinib | Experimental | Drug: Combination of Veliparib + LapatinibLapatinib 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Patient must pathologically documented stage IV breast cancer.
- Tumor must be HER-2 negative, and estrogen and progesterone receptors negative. Patients with BRCA 1 or 2 mutations will not be included.
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension.
- Biopsy of a metastatic lesion is not required for protocol entry but all patients with reasonably accessible lesions must agree to biopsy. (Lung and brain metastasis will not be biopsied.) Patients with no reasonably accessible lesions can be enrolled in the trial.
- Prior Therapy:
Key exclusion criteria (13 listed)
- Patients may not be receiving any other investigational agents.
- No prior use of anthracyclines and taxanes for metastatic disease or in the adjuvant or neoadjuvant setting.
- Metastatic lesions identifiable only by PET.
- QTc (corrected QT) >470 msec. Excluded are patients who may develop prolongation of QTc. These conditions include patients with hypokalemia or hypomagnesemia, congenital long QT syndrome, patients taking anti- arrhythmic medicines or other medicinal products that lead to QT prolongation, and cumulative high-dose anthracycline therapy.
- Patients may not be receiving concurrent chemotherapy for treatment of metastatic disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combination of Veliparib + LapatinibAlso: Veliparib (ABT-888), Lapatinib (Tykerb)Treatment cannot be in administered conjunction with other chemotherapy, targeted therapy, radiation therapy, or other investigational drugs. | Drug | Combination of Veliparib + Lapatinib |
Primary outcome
Number of Subjects Experiencing Study-related Toxicities When Taking Veliparib in Combination With Lapatinib
Time frame: baseline to 4 years
Drug related toxicities for the safety analysis are defined as: a) any grade 3 or 4 non-hematologic toxicity except alopecia and nausea which is not refractory to anti-emetics; b) failure to recover to baseline (except alopecia) after delaying the next dose by more than 14 days; c) grade 3 or 4 neutropenia complicated by fever equal to or greater than 38.50 degrees C or infection, or grade 4 neutropenia of a least 7 days duration; or d) grade 4 thrombocytopenia, or grade 3 thrombocytopenia complicated by hemorrhage. Toxicity evaluation of the patients enrolled in the trial will be done using the NCI Common Toxicity Criteria.
5 secondary outcomes
Number of Subjects With Objective Response Rate (ORR) at 4 Years Post Baseline (Complete Responses [CRs] Plus Partial Responses [PRs]
Time frame: 4 years post baseline
Number of Subjects With Progression Free Survival (PFS) at 4 Years After Start of Study.
Time frame: Baseline to 4 years
DNA Methylation and RNA Transcriptome Will be Evaluated Before and After Therapy; Baseline Pattern Will be Compared With the Post Treatment Pattern to Identify Markers of Response or Resistance.
Time frame: Within 4 weeks of baseline (treatment initiation)
Measure Numbers of Circulating Tumor Cells Before and After Therapy
Time frame: Before and after Cycle 1 (up to 28 days)
Peak Plasma Concentration of Veliparib and Palatinib When Given in Combination.
Time frame: Up to day 10
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33663560Stringer-Reasor EM, May JE, Olariu E, Caterinicchia V, Li Y, Chen D, Della Manna DL, Rocque GB, Vaklavas C, Falkson CI, Nabell LM, Acosta EP, Forero-Torres A, Yang ES. An open-label, pilot study of veliparib and lapatinib in patients with metastatic, triple-negative breast cancer. Breast Cancer Res. 2021 Mar 4;23(1):30. doi: 10.1186/s13058-021-01408-9.
- An open-label, pilot study of veliparib and lapatinib in patients with metastatic, triple-negative breast cancer \| Breast Cancer ResearchLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andres Forero, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combination of Veliparib + Lapatinib in people with Metastatic Triple Negative Breast Cancer, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects Experiencing Study-related Toxicities When Taking Veliparib in Combination With Lapatinib (time frame: baseline to 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02158507, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.