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Carboplatin and Combination Chemotherapy With or Without Veliparib in Treating Patients With Stage IIB-IIIC Breast Cancer

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ClinicalTrials.gov Identifier: NCT01818063
Recruitment Status : Completed
First Posted : March 26, 2013
Results First Posted : January 16, 2018
Last Update Posted : October 28, 2019
Sponsor:
Collaborator:
Susan G. Komen Breast Cancer Foundation
Information provided by (Responsible Party):
Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Estrogen Receptor-negative Breast Cancer
HER2-negative Breast Cancer
Progesterone Receptor-negative Breast Cancer
Stage II Breast Cancer
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Triple-negative Breast Cancer
Interventions Drug: Paclitaxel
Drug: Carboplatin
Drug: Doxorubicin
Drug: Cyclophosphamide
Drug: Veliparib
Enrollment 9
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm 1 (Paclitaxel, Carboplatin) Arm 2 (Veliparib, Paclitaxel, Carboplatin)
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 5 4
Completed 5 4
Not Completed 0 0
Arm/Group Title Arm 1 (Paclitaxel, Carboplatin) Arm 2 (Veliparib, Paclitaxel, Carboplatin) Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 5 4 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 4 participants 9 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
  60.0%
4
 100.0%
7
  77.8%
>=65 years
2
  40.0%
0
   0.0%
2
  22.2%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 4 participants 9 participants
Female
5
 100.0%
4
 100.0%
9
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 4 participants 9 participants
Hispanic or Latino
0
   0.0%
1
  25.0%
1
  11.1%
Not Hispanic or Latino
5
 100.0%
3
  75.0%
8
  88.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 4 participants 9 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
  20.0%
2
  50.0%
3
  33.3%
White
4
  80.0%
2
  50.0%
6
  66.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 5 participants 4 participants 9 participants
5
 100.0%
4
 100.0%
9
 100.0%
1.Primary Outcome
Title Count of Participants That Achieve Pathologic Complete Response (PCR)
Hide Description 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.
Time Frame 36 months following surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 (Paclitaxel, Carboplatin) Arm 2 (Veliparib, Paclitaxel, Carboplatin)
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 5 4
Measure Type: Count of Participants
Unit of Measure: Participants
3
  60.0%
3
  75.0%
2.Secondary Outcome
Title Overall Clinical Response
Hide Description

The 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.

Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 (Paclitaxel, Carboplatin) Arm 2 (Veliparib, Paclitaxel, Carboplatin)
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 5 4
Measure Type: Count of Participants
Unit of Measure: Participants
Progressive Disease
1
  20.0%
1
  25.0%
Partial Response
2
  40.0%
1
  25.0%
Pathological Complete Response
2
  40.0%
2
  50.0%
3.Secondary Outcome
Title Relapse Free Survival
Hide Description Analyzed using Kaplan-Meier methods, stratified by study group, and the log rank test will be completed.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Sincere efforts have been made to gather and report the data, however, no data is available for this outcome measure.
Arm/Group Title Arm 1 (Paclitaxel, Carboplatin) Arm 2 (Veliparib, Paclitaxel, Carboplatin)
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1 (Paclitaxel, Carboplatin) Arm 2 (Veliparib, Paclitaxel, Carboplatin)
Hide Arm/Group Description

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

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

All-Cause Mortality
Arm 1 (Paclitaxel, Carboplatin) Arm 2 (Veliparib, Paclitaxel, Carboplatin)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)      0/4 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1 (Paclitaxel, Carboplatin) Arm 2 (Veliparib, Paclitaxel, Carboplatin)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/5 (20.00%)      0/4 (0.00%)    
Infections and infestations     
Viral Meningitis *  1/5 (20.00%)  1 0/4 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm 1 (Paclitaxel, Carboplatin) Arm 2 (Veliparib, Paclitaxel, Carboplatin)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/5 (60.00%)      1/4 (25.00%)    
Blood and lymphatic system disorders     
Alkaline phosphatase Increased *  1/5 (20.00%)  7 1/4 (25.00%)  1
ALT Increase *  1/5 (20.00%)  1 1/4 (25.00%)  1
Anemia *  2/5 (40.00%)  2 1/4 (25.00%)  1
Hyperglycemia *  1/5 (20.00%)  2 0/4 (0.00%)  0
Hypoglycemia *  1/5 (20.00%)  2 0/4 (0.00%)  0
Platelet Count decreased *  1/5 (20.00%)  1 1/4 (25.00%)  1
Gastrointestinal disorders     
Constipation *  1/5 (20.00%)  1 0/4 (0.00%)  0
Diarrhea *  2/5 (40.00%)  2 0/4 (0.00%)  0
Diverticulitis *  1/5 (20.00%)  1 0/4 (0.00%)  0
Laryngeal Inflammation *  0/5 (0.00%)  0 1/4 (25.00%)  1
Mucositis *  0/5 (0.00%)  0 1/4 (25.00%)  2
Nausea *  1/5 (20.00%)  2 1/4 (25.00%)  2
Vomiting *  1/5 (20.00%)  1 0/4 (0.00%)  0
General disorders     
Bone Pain *  2/5 (40.00%)  7 0/4 (0.00%)  0
Dehydration *  1/5 (20.00%)  2 1/4 (25.00%)  1
Dizziness *  1/5 (20.00%)  1 0/4 (0.00%)  0
Fall *  2/5 (40.00%)  2 1/4 (25.00%)  1
Fatigue *  1/5 (20.00%)  1 0/4 (0.00%)  0
Flu like symptoms *  2/5 (40.00%)  3 1/4 (25.00%)  2
Hot flashes *  1/5 (20.00%)  1 0/4 (0.00%)  0
Night Sweats *  0/5 (0.00%)  0 1/4 (25.00%)  1
Pain *  0/5 (0.00%)  0 1/4 (25.00%)  1
Runny nose *  0/5 (0.00%)  0 1/4 (25.00%)  1
Scalp pain *  1/5 (20.00%)  1 0/4 (0.00%)  0
Voice alteration *  1/5 (20.00%)  1 0/4 (0.00%)  0
Infections and infestations     
Infection UTI *  1/5 (20.00%)  1 0/4 (0.00%)  0
Injury, poisoning and procedural complications     
Head Injury *  2/5 (40.00%)  3 1/4 (25.00%)  1
Nervous system disorders     
Insomnia *  1/5 (20.00%)  1 1/4 (25.00%)  2
Neuropathy *  0/5 (0.00%)  0 1/4 (25.00%)  1
Paresthesia *  0/5 (0.00%)  0 1/4 (25.00%)  1
Sciatica *  1/5 (20.00%)  1 0/4 (0.00%)  0
Psychiatric disorders     
Anxiety *  1/5 (20.00%)  1 0/4 (0.00%)  0
Psychiatric Disorders, mood *  0/5 (0.00%)  0 1/4 (25.00%)  1
Renal and urinary disorders     
Urinary Urgency *  1/5 (20.00%)  1 0/4 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Cough *  1/5 (20.00%)  2 0/4 (0.00%)  0
Dyspnea *  1/5 (20.00%)  1 0/4 (0.00%)  0
Skin and subcutaneous tissue disorders     
Alopecia *  2/5 (40.00%)  2 1/4 (25.00%)  1
Burn *  2/5 (40.00%)  7 0/4 (0.00%)  0
Rash Acneiform *  0/5 (0.00%)  0 1/4 (25.00%)  1
Rash Maculopapular *  1/5 (20.00%)  1 1/4 (25.00%)  1
Scratch *  1/5 (20.00%)  1 0/4 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Edith Mitchell
Organization: Sidney Kimmel Cancer Center at Thomas Jefferson University
Phone: 215-955-8874
EMail: edith.mitchell@jefferson.edu
Publications:
NCCN. NCCN Clinical Practice Guidelines in Oncology, Version 2.2011. 2011.
O'Shaughnessy J, Schwartzberg S, Danso M, Rugo H, Miller K, Yardley D. A randomized phase III study of iniparib (BSI-201) in combination with gemcitabine/carboplatin (G/C) in metastatic triple-negative breast cancer (TNBC). J Clin Oncol 2011;29 (suppl; abstr 1007).
Layout table for additonal information
Responsible Party: Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )
ClinicalTrials.gov Identifier: NCT01818063     History of Changes
Other Study ID Numbers: 12G.376
2012-47 ( Other Identifier: CCRRC )
First Submitted: March 21, 2013
First Posted: March 26, 2013
Results First Submitted: December 14, 2017
Results First Posted: January 16, 2018
Last Update Posted: October 28, 2019