Trial Outcomes & Findings for Pilot Study of Veliparib (ABT-888) and Lapatinib (Tykerb) in Patients With Metastatic, Triple Negative Breast Cancer (NCT NCT02158507)

Last Updated: 2026-01-22

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

baseline to 4 years

Results posted on

2026-01-22

Participant Flow

Participant milestones

Participant milestones
Measure	Combination of Veliparib + Lapatinib 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. Combination of Veliparib + Lapatinib: Treatment cannot be in administered conjunction with other chemotherapy, targeted therapy, radiation therapy, or other investigational drugs.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Combination of Veliparib + Lapatinib n=20 Participants 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. Combination of Veliparib + Lapatinib: Treatment cannot be in administered conjunction with other chemotherapy, targeted therapy, radiation therapy, or other investigational drugs.
Age, Categorical <=18 years	0 Participants n=270 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=270 Participants
Age, Categorical >=65 years	0 Participants n=270 Participants
Age, Continuous	50 years n=270 Participants
Sex: Female, Male Female	20 Participants n=270 Participants
Sex: Female, Male Male	0 Participants n=270 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=270 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=270 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=270 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=270 Participants
Race (NIH/OMB) Asian	0 Participants n=270 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=270 Participants
Race (NIH/OMB) Black or African American	9 Participants n=270 Participants
Race (NIH/OMB) White	11 Participants n=270 Participants
Race (NIH/OMB) More than one race	0 Participants n=270 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=270 Participants
Region of Enrollment United States	20 participants n=270 Participants

PRIMARY outcome

Timeframe: baseline to 4 years

Outcome measures

Outcome measures
Measure	Combination of Veliparib + Lapatinib n=17 Participants 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. Combination of Veliparib + Lapatinib: Treatment cannot be in administered conjunction with other chemotherapy, targeted therapy, radiation therapy, or other investigational drugs.
Number of Subjects Experiencing Study-related Toxicities When Taking Veliparib in Combination With Lapatinib fatigue	6 count of participants
Number of Subjects Experiencing Study-related Toxicities When Taking Veliparib in Combination With Lapatinib diarrhea	5 count of participants
Number of Subjects Experiencing Study-related Toxicities When Taking Veliparib in Combination With Lapatinib constipation	5 count of participants
Number of Subjects Experiencing Study-related Toxicities When Taking Veliparib in Combination With Lapatinib insomnia	5 count of participants
Number of Subjects Experiencing Study-related Toxicities When Taking Veliparib in Combination With Lapatinib vomiting	3 count of participants
Number of Subjects Experiencing Study-related Toxicities When Taking Veliparib in Combination With Lapatinib anemia	3 count of participants
Number of Subjects Experiencing Study-related Toxicities When Taking Veliparib in Combination With Lapatinib headache	3 count of participants
Number of Subjects Experiencing Study-related Toxicities When Taking Veliparib in Combination With Lapatinib dizziness	2 count of participants
Number of Subjects Experiencing Study-related Toxicities When Taking Veliparib in Combination With Lapatinib dyspnea	2 count of participants
Number of Subjects Experiencing Study-related Toxicities When Taking Veliparib in Combination With Lapatinib rash	2 count of participants

SECONDARY outcome

Timeframe: 4 years post baseline

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.

Outcome measures

Outcome measures
Measure	Combination of Veliparib + Lapatinib n=17 Participants 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. Combination of Veliparib + Lapatinib: Treatment cannot be in administered conjunction with other chemotherapy, targeted therapy, radiation therapy, or other investigational drugs.
Number of Subjects With Objective Response Rate (ORR) at 4 Years Post Baseline (Complete Responses [CRs] Plus Partial Responses [PRs]	17 Participants

SECONDARY outcome

Timeframe: Baseline to 4 years

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

Outcome measures

Outcome measures
Measure	Combination of Veliparib + Lapatinib n=17 Participants 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. Combination of Veliparib + Lapatinib: Treatment cannot be in administered conjunction with other chemotherapy, targeted therapy, radiation therapy, or other investigational drugs.
Number of Subjects With Progression Free Survival (PFS) at 4 Years After Start of Study.	17 Participants

SECONDARY outcome

Timeframe: Within 4 weeks of baseline (treatment initiation)

Population: Progressive Disease (PD)/Partial Response (PR)=Fold Change

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.

Outcome measures

Outcome measures
Measure	Combination of Veliparib + Lapatinib n=17 Participants 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. Combination of Veliparib + Lapatinib: Treatment cannot be in administered conjunction with other chemotherapy, targeted therapy, radiation therapy, or other investigational drugs.
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. CRYAB	-4.55 percentage of fold change
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. RASGRF1	-3.79 percentage of fold change
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. CALML5	-15.74 percentage of fold change
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. MMP7	-12.45 percentage of fold change
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. BRCA1	-4.82 percentage of fold change
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. PLA2G3	4.74 percentage of fold change
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. COL11A1	-4.48 percentage of fold change
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. CKB	-4.36 percentage of fold change
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. LFNG	4.13 percentage of fold change
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. PIK3R3	-3.6 percentage of fold change
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. SOCS1	3.46 percentage of fold change
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. GJB2	3.15 percentage of fold change
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. PTCH1	-3.05 percentage of fold change
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. STAT1	2.96 percentage of fold change
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. COL27A1	-2.57 percentage of fold change
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. SOCS2	2.53 percentage of fold change
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. FGFR2	-2.49 percentage of fold change
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. NOTCH1	-2.27 percentage of fold change
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. HGF	2.21 percentage of fold change

SECONDARY outcome

Timeframe: Before and after Cycle 1 (up to 28 days)

Population: This lab test was not performed. Circulating Tumor Cells were no longer clinically relevant upon IRB approval of this study. This was inadvertently not removed from the protocol or CT.gov outcome measures at the start of the study. CTC was being studied by a different investigator (Dr. Haluska) was at Mayo at the initial writing of the protocol and subsequently left and was never with UAB

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to day 10

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).

Outcome measures

Outcome measures
Measure	Combination of Veliparib + Lapatinib n=17 Participants 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. Combination of Veliparib + Lapatinib: Treatment cannot be in administered conjunction with other chemotherapy, targeted therapy, radiation therapy, or other investigational drugs.
Peak Plasma Concentration of Veliparib and Palatinib When Given in Combination.	2600 nanograms per mL Interval 2300.0 to 2900.0

Adverse Events

Combination of Veliparib + Lapatinib

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Combination of Veliparib + Lapatinib n=17 participants at risk 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. Combination of Veliparib + Lapatinib: Treatment cannot be in administered conjunction with other chemotherapy, targeted therapy, radiation therapy, or other investigational drugs.
Nervous system disorders fatigue	100.0% 17/17 • Number of events 17 • 4 years
Gastrointestinal disorders diarrhea	100.0% 17/17 • Number of events 17 • 4 years

Additional Information

Dr. Erica Stringer-Reasor

The University of Alabama at Birmingham

Phone: 2059759375

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place