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Neoadjuvant Platinum-based Chemoradiation Therapy for Locally Advanced Triple Negative Breast Cancer

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01167192
First Posted: July 22, 2010
Last Update Posted: December 30, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Washington University School of Medicine
Results First Submitted: September 8, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Breast Neoplasms
Interventions: Drug: Cisplatin
Drug: Carboplatin
Radiation: Radiation therapy
Procedure: Mastectomy (recommended but not mandatory)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study opened to enrollment on 02/04/2011 and closed to enrollment on 09/10/2013.

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
Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation

Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.

Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.

Recommended mastectomy

Recommended adjuvant chemotherapy

-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)


Participant Flow:   Overall Study
    Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation
STARTED   10 
COMPLETED   6 
NOT COMPLETED   4 
Adverse Event                1 
Death                1 
Withdrawal by Subject                1 
Insurance denial                1 



  Baseline Characteristics
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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
Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation

Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.

Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.

Recommended mastectomy

Recommended adjuvant chemotherapy

-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)


Baseline Measures
   Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation 
Overall Participants Analyzed 
[Units: Participants]
 10 
Age 
[Units: Years]
Median (Full Range)
 48 
 (29 to 73) 
Gender 
[Units: Participants]
Count of Participants
 
Female      10 100.0% 
Male      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   10 


  Outcome Measures
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1.  Primary:   Response Rate as Measured by Number of Participants Who Achieved Complete Response (CR) or Partial Response (PR)   [ Time Frame: Prior to surgery (approximately 12-16 weeks from registration) ]

2.  Primary:   Relationship Between Tumor Response and Deficiencies in DNA Repair Mechanisms   [ Time Frame: Prior to surgery (approximately 12-16 weeks from registration) ]

3.  Secondary:   Time to Disease Progression   [ Time Frame: Up to 5 years from registration ]

4.  Secondary:   Number of Participants With Surgical Complications   [ Time Frame: 30 days post surgery (approximately 16-20 weeks from registration) ]

5.  Secondary:   Determine the Effect of Neoadjuvant Chemoradiation Therapy in Disseminated Cancer Cells in the Bone Marrow   [ Time Frame: Up to 15 months from registration ]

6.  Secondary:   Overall Survival Rate   [ Time Frame: Median follow-up was 59.9 months ]

7.  Secondary:   Medical Toxicities as Measured by Number of Grade 3 or Higher Adverse Events   [ Time Frame: 30 days post surgery (approximately 16-20 weeks after start of registration) ]

8.  Secondary:   Successful Development of Animal Models of Triple Negative Breast Cancers as Measured by the Ability to Grow the Tumors in Mice.   [ Time Frame: At the time of IVAD placement and at the time of surgery ]

9.  Secondary:   Successful Development of Animal Models for Triple Negative Breast Cancers as Measured by the Ability to Passage the Tumors in Mice   [ Time Frame: At the time of IVAD placement and at the time of surgery ]

10.  Secondary:   Successful Development of Animal Models in Triple Negative Breast Cancers as Measured by the Ability of the Tumors to Metastasize to Other Organs   [ Time Frame: At the time of IVAD placement and at the time of surgery ]

11.  Secondary:   Successful Development of Animal Models of Triple Negative Breast Cancer as Measured by the Genetic Similarity Between the Primary Tumor and the Tumor in Animals   [ Time Frame: At the time of IVAD placement and at the time of surgery ]

12.  Secondary:   Determine the Effect of Neoadjuvant Chemoradiation Therapy in Disseminated Cancer Cells in the Bone Marrow and the Correlation to Tumor Response   [ Time Frame: Up to 15 months from time of registration ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Rebecca Aft, M.D., Ph.D.
Organization: Washington University School of Medicine
phone: 314-747-0063
e-mail: aftr@wustl.edu


Publications:

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01167192     History of Changes
Other Study ID Numbers: 201310089
First Submitted: July 14, 2010
First Posted: July 22, 2010
Results First Submitted: September 8, 2016
Results First Posted: October 28, 2016
Last Update Posted: December 30, 2016



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