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Trial record 1 of 1 for:    NCT01818063
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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 : Active, not recruiting
First Posted : March 26, 2013
Results First Posted : January 16, 2018
Last Update Posted : February 13, 2018
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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


Participant Flow:   Overall Study
    Arm 1 (Paclitaxel, Carboplatin)   Arm 2 (Veliparib, Paclitaxel, Carboplatin)
STARTED   5   4 
COMPLETED   5   4 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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

Total Total of all reporting groups

Baseline Measures
   Arm 1 (Paclitaxel, Carboplatin)   Arm 2 (Veliparib, Paclitaxel, Carboplatin)   Total 
Overall Participants Analyzed 
[Units: Participants]
 5   4   9 
Age 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of Participants
     
Female      5 100.0%      4 100.0%      9 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of 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) 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of Participants
     
United States   5   4   9 


  Outcome Measures

1.  Primary:   Count of Participants That Achieve Pathologic Complete Response (PCR)   [ Time Frame: 36 months following surgery ]

2.  Secondary:   Overall Clinical Response   [ Time Frame: Up to 3 years ]
Results not yet reported.   Anticipated Reporting Date:   04/2019  

3.  Secondary:   Relapse Free Survival   [ Time Frame: Up to 3 years ]
Results not yet reported.   Anticipated Reporting Date:   04/2019  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Edith Mitchell
Organization: Sidney Kimmel Cancer Center at Thomas Jefferson University
phone: 215-955-8874
e-mail: 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).


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: February 13, 2018