Trial Outcomes & Findings for Carboplatin and Combination Chemotherapy With or Without Veliparib in Treating Patients With Stage IIB-IIIC Breast Cancer (NCT NCT01818063)
NCT ID: NCT01818063
Last Updated: 2025-04-30
Results Overview
PCR is defined as the absence of any residual invasive cancer on hematoxylin and eosin (H\&E) evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
36 months following surgery
Results posted on
2025-04-30
Participant Flow
Participant milestones
| Measure |
Arm 1 (Paclitaxel, Carboplatin)
Patients receive paclitaxel IV and carboplatin IV on day 1 (course 1 only) or day 2 (courses 2-12). Treatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity. Beginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Paclitaxel: Given IV
Carboplatin: Given IV
Doxorubicin: Given IV
Cyclophosphamide: Given IV
|
Arm 2 (Veliparib, Paclitaxel, Carboplatin)
Patients receive veliparib PO BID on days 1-5. Patients also receive paclitaxel IV and carboplatin IV on day 3 (course 1 only) or day 4 (courses 2-12). Treatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity. Beginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Paclitaxel: Given IV
Carboplatin: Given IV
Doxorubicin: Given IV
Cyclophosphamide: Given IV
Veliparib: Given PO
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
4
|
|
Overall Study
COMPLETED
|
5
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Carboplatin and Combination Chemotherapy With or Without Veliparib in Treating Patients With Stage IIB-IIIC Breast Cancer
Baseline characteristics by cohort
| Measure |
Arm 1 (Paclitaxel, Carboplatin)
n=5 Participants
Patients receive paclitaxel IV and carboplatin IV on day 1 (course 1 only) or day 2 (courses 2-12). Treatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity. Beginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Paclitaxel: Given IV
Carboplatin: Given IV
Doxorubicin: Given IV
Cyclophosphamide: Given IV
|
Arm 2 (Veliparib, Paclitaxel, Carboplatin)
n=4 Participants
Patients receive veliparib PO BID on days 1-5. Patients also receive paclitaxel IV and carboplatin IV on day 3 (course 1 only) or day 4 (courses 2-12). Treatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity. Beginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Paclitaxel: Given IV
Carboplatin: Given IV
Doxorubicin: Given IV
Cyclophosphamide: Given IV
Veliparib: Given PO
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 36 months following surgeryPCR is defined as the absence of any residual invasive cancer on hematoxylin and eosin (H\&E) evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes.
Outcome measures
| Measure |
Arm 1 (Paclitaxel, Carboplatin)
n=5 Participants
Patients receive paclitaxel IV and carboplatin IV on day 1 (course 1 only) or day 2 (courses 2-12). Treatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity. Beginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Paclitaxel: Given IV
Carboplatin: Given IV
Doxorubicin: Given IV
Cyclophosphamide: Given IV
|
Arm 2 (Veliparib, Paclitaxel, Carboplatin)
n=4 Participants
Patients receive veliparib PO BID on days 1-5. Patients also receive paclitaxel IV and carboplatin IV on day 3 (course 1 only) or day 4 (courses 2-12). Treatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity. Beginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Paclitaxel: Given IV
Carboplatin: Given IV
Doxorubicin: Given IV
Cyclophosphamide: Given IV
Veliparib: Given PO
|
|---|---|---|
|
Count of Participants That Achieve Pathologic Complete Response (PCR)
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsThe count and percentage of subjects with each category of overall clinical response will be summarized by presence of baseline measureable disease (i.e., complete response \[CR\], partial response \[PR\], stable disease \[SD\], progressive disease \[PD\], unable to evaluate \[UE\], neurogenerative disease \[ND\]). Evaluated per Response Evaluation Criteria In Solid Tumors (RECIST v1.0) as assessed b 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. Beta will be used as priors for combination regimens in calculating the posterior distribution of the pathologic complete response \[pCR\] for each respective treatment group. Among subjects with measurable disease, a 95% credible region will be calculated for the odds ratio for each treatment combination relative to each other.
Outcome measures
| Measure |
Arm 1 (Paclitaxel, Carboplatin)
n=5 Participants
Patients receive paclitaxel IV and carboplatin IV on day 1 (course 1 only) or day 2 (courses 2-12). Treatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity. Beginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Paclitaxel: Given IV
Carboplatin: Given IV
Doxorubicin: Given IV
Cyclophosphamide: Given IV
|
Arm 2 (Veliparib, Paclitaxel, Carboplatin)
n=4 Participants
Patients receive veliparib PO BID on days 1-5. Patients also receive paclitaxel IV and carboplatin IV on day 3 (course 1 only) or day 4 (courses 2-12). Treatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity. Beginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Paclitaxel: Given IV
Carboplatin: Given IV
Doxorubicin: Given IV
Cyclophosphamide: Given IV
Veliparib: Given PO
|
|---|---|---|
|
Overall Clinical Response
Progressive Disease
|
1 Participants
|
1 Participants
|
|
Overall Clinical Response
Partial Response
|
2 Participants
|
1 Participants
|
|
Overall Clinical Response
Pathological Complete Response
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Sincere efforts have been made to gather and report the data, however, no data is available for this outcome measure.
Analyzed using Kaplan-Meier methods, stratified by study group, and the log rank test will be completed.
Outcome measures
Outcome data not reported
Adverse Events
Arm 1 (Paclitaxel, Carboplatin)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm 2 (Veliparib, Paclitaxel, Carboplatin)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1 (Paclitaxel, Carboplatin)
n=5 participants at risk
Patients receive paclitaxel IV and carboplatin IV on day 1 (course 1 only) or day 2 (courses 2-12). Treatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity. Beginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Paclitaxel: Given IV
Carboplatin: Given IV
Doxorubicin: Given IV
Cyclophosphamide: Given IV
|
Arm 2 (Veliparib, Paclitaxel, Carboplatin)
n=4 participants at risk
Patients receive veliparib PO BID on days 1-5. Patients also receive paclitaxel IV and carboplatin IV on day 3 (course 1 only) or day 4 (courses 2-12). Treatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity. Beginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Paclitaxel: Given IV
Carboplatin: Given IV
Doxorubicin: Given IV
Cyclophosphamide: Given IV
Veliparib: Given PO
|
|---|---|---|
|
Infections and infestations
Viral Meningitis
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
Other adverse events
| Measure |
Arm 1 (Paclitaxel, Carboplatin)
n=5 participants at risk
Patients receive paclitaxel IV and carboplatin IV on day 1 (course 1 only) or day 2 (courses 2-12). Treatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity. Beginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Paclitaxel: Given IV
Carboplatin: Given IV
Doxorubicin: Given IV
Cyclophosphamide: Given IV
|
Arm 2 (Veliparib, Paclitaxel, Carboplatin)
n=4 participants at risk
Patients receive veliparib PO BID on days 1-5. Patients also receive paclitaxel IV and carboplatin IV on day 3 (course 1 only) or day 4 (courses 2-12). Treatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity. Beginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Paclitaxel: Given IV
Carboplatin: Given IV
Doxorubicin: Given IV
Cyclophosphamide: Given IV
Veliparib: Given PO
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
40.0%
2/5 • Number of events 2
|
25.0%
1/4 • Number of events 1
|
|
Blood and lymphatic system disorders
Alkaline phosphatase Increased
|
20.0%
1/5 • Number of events 7
|
25.0%
1/4 • Number of events 1
|
|
Blood and lymphatic system disorders
ALT Increase
|
20.0%
1/5 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
|
Blood and lymphatic system disorders
Anemia
|
40.0%
2/5 • Number of events 2
|
25.0%
1/4 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
General disorders
Bone Pain
|
40.0%
2/5 • Number of events 7
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Burn
|
40.0%
2/5 • Number of events 7
|
0.00%
0/4
|
|
Gastrointestinal disorders
Constipation
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
1/5 • Number of events 2
|
0.00%
0/4
|
|
General disorders
Dehydration
|
20.0%
1/5 • Number of events 2
|
25.0%
1/4 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
40.0%
2/5 • Number of events 2
|
0.00%
0/4
|
|
Gastrointestinal disorders
Diverticulitis
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
General disorders
Dizziness
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
General disorders
Fall
|
40.0%
2/5 • Number of events 2
|
25.0%
1/4 • Number of events 1
|
|
General disorders
Fatigue
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
General disorders
Flu like symptoms
|
40.0%
2/5 • Number of events 3
|
25.0%
1/4 • Number of events 2
|
|
Injury, poisoning and procedural complications
Head Injury
|
40.0%
2/5 • Number of events 3
|
25.0%
1/4 • Number of events 1
|
|
General disorders
Hot flashes
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
Blood and lymphatic system disorders
Hyperglycemia
|
20.0%
1/5 • Number of events 2
|
0.00%
0/4
|
|
Blood and lymphatic system disorders
Hypoglycemia
|
20.0%
1/5 • Number of events 2
|
0.00%
0/4
|
|
Infections and infestations
Infection UTI
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
Nervous system disorders
Insomnia
|
20.0%
1/5 • Number of events 1
|
25.0%
1/4 • Number of events 2
|
|
Gastrointestinal disorders
Laryngeal Inflammation
|
0.00%
0/5
|
25.0%
1/4 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis
|
0.00%
0/5
|
25.0%
1/4 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
20.0%
1/5 • Number of events 2
|
25.0%
1/4 • Number of events 2
|
|
Nervous system disorders
Neuropathy
|
0.00%
0/5
|
25.0%
1/4 • Number of events 1
|
|
General disorders
Night Sweats
|
0.00%
0/5
|
25.0%
1/4 • Number of events 1
|
|
General disorders
Pain
|
0.00%
0/5
|
25.0%
1/4 • Number of events 1
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/5
|
25.0%
1/4 • Number of events 1
|
|
Blood and lymphatic system disorders
Platelet Count decreased
|
20.0%
1/5 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
|
Psychiatric disorders
Psychiatric Disorders, mood
|
0.00%
0/5
|
25.0%
1/4 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash Acneiform
|
0.00%
0/5
|
25.0%
1/4 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash Maculopapular
|
20.0%
1/5 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
|
General disorders
Runny nose
|
0.00%
0/5
|
25.0%
1/4 • Number of events 1
|
|
General disorders
Scalp pain
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
Nervous system disorders
Sciatica
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Scratch
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
Renal and urinary disorders
Urinary Urgency
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
General disorders
Voice alteration
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
Additional Information
Dr. Edith Mitchell
Sidney Kimmel Cancer Center at Thomas Jefferson University
Phone: 215-955-8874
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place