Pilot Study of Veliparib (ABT-888) and Lapatinib (Tykerb) in Patients With Metastatic, Triple Negative Breast Cancer

NCT02158507 | Completed Results DMC

• 2 other identifiers: F131219003 (UAB 1372)000504723
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Metastatic Triple Negative Breast Cancer

Keywords

triple negative breast cancer (TNBC); Veliparib; Lapatinib; estrogen receptor negative; progesterone receptor negative; (HER-2-Neu) negative

Outcome Measures

Primary Outcomes (1)

• 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.

  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]

  4 years post baseline

• Number of Subjects With Progression Free Survival (PFS) at 4 Years After Start of Study.

  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.

  Within 4 weeks of baseline (treatment initiation)

• Measure Numbers of Circulating Tumor Cells Before and After Therapy

  Before and after Cycle 1 (up to 28 days)

• Peak Plasma Concentration of Veliparib and Palatinib When Given in Combination.

  Up to day 10

Study Arms (1)

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.

Drug: Combination of Veliparib + Lapatinib

Interventions

Combination of Veliparib + Lapatinib DRUG

Treatment cannot be in administered conjunction with other chemotherapy, targeted therapy, radiation therapy, or other investigational drugs.

Also known as: Veliparib (ABT-888), Lapatinib (Tykerb)

Combination of Veliparib + Lapatinib

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Breast Cancer Research Foundation of Alabama: collaborator
• GlaxoSmithKline: collaborator
• AbbVie: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

• 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.

  PMID: 33663560 DERIVED

Related Links

• An open-label, pilot study of veliparib and lapatinib in patients with metastatic, triple-negative breast cancer \| Breast Cancer Research

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Lapatinib; veliparib

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Erica Stringer-Reasor
• Organization: The University of Alabama at Birmingham

esreasor@uabmc.edu

2059759375

Study Officials

• Andres Forero, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 29, 2014
• First Posted: June 9, 2014
• Study Start: September 4, 2014
• Primary Completion: July 22, 2021
• Study Completion: July 22, 2021
• Last Updated: January 22, 2026
• Results First Posted: January 22, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)