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Platinum for Triple-Negative Metastatic Breast Cancer and Evaluation of p63/p73 as a Biomarker of Response

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
Dana-Farber Cancer Institute
North Shore Medical Center
Information provided by (Responsible Party):
Steven Isakoff, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00483223
First received: June 5, 2007
Last updated: May 25, 2017
Last verified: May 2017
Results First Received: April 13, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: Cisplatin
Drug: carboplatin

  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
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
Cisplatin or Carboplatin

Cisplatin or carboplatin (1 arm, 2 cohorts)

Cisplatin: Given intravenously on the first day of each 3-week treatment cycle at 75mg/m2. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects.

carboplatin: Given intravenously on the first day of each 3-week treatment cycle at AUC 6. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects.


Participant Flow:   Overall Study
    Cisplatin or Carboplatin
STARTED   86 
COMPLETED   86 
NOT COMPLETED   0 



  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
Single Arm

Cisplatin or carboplatin (1 arm, 2 cohorts)

Cisplatin: Given intravenously on the first day of each 3-week treatment cycle at 75mg/m2. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects.

carboplatin: Given intravenously on the first day of each 3-week treatment cycle at AUC 6. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects.


Baseline Measures
   Single Arm 
Overall Participants Analyzed 
[Units: Participants]
 86 
Age 
[Units: Years]
Median (Full Range)
 52 
 (30 to 78) 
Age, Customized 
[Units: Participants]
Count of Participants
 
< 40   13 
40-65   63 
> 65   10 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      86 100.0% 
Male      0   0.0% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
 
White   69 
African American   7 
Asian   4 
> one or other   6 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   86 
ECOG PS [1] 
[Units: Participants]
Count of Participants
 
 55 
 20 
 5 
Not reported   6 
[1]

Eastern Cooperative Oncology Group performance score. The performance scale describes a participants level of functioning in terms of their ability to care for themselves. daily activity, and physical ability.

0. Fully active, able to carry on all pre-disease performance without restriction

  1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work
  2. Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
Site of metastases [1] 
[Units: Participants]
 
Lymph nodes   54 
Lung   44 
Bone   25 
Liver   25 
Skin   16 
Brain   4 
[1] The number of participants with metastases at the specified cites.
Stage at initial diagnosis of breast cancer [1] 
[Units: Participants]
Count of Participants
 
 10 
 32 
 37 
 7 
[1] This describes the stage of breast cancer at diagnosis according to the American Joint Commission on Cancer (AJCC) Version 7. Generally, stage 1 is a cancer that is less than 2 cm and lymph node negative, stage 2 is a tumor between 2-5 cm and/or 1-3 lymph nodes positive, and stage 3 is a tumor with more than 3 lymph nodes positive or a tumor invading the skin. Stage 4 indicates that the cancer has spread into distant parts of the body. In general, lower stage cancers have a better prognosis, and higher stage cancers are more advanced.
Prior chemotherapy [1] 
[Units: Participants]
 
Adjuvant/neoadjuvant   74 
Anthracycline   65 
Taxane   67 
[1] The prior chemotherapy received by the participants.The rows represent the number of participants that received any adjuvant/neoadjuvant as well as the number of participant that received Anthracycline or Taxane as their adjuvant/neoadjuvant drug.
Treatment cohort [1] 
[Units: Participants]
Count of Participants
 
Cisplatin (cohort 1)   43 
Carboplatin (cohort 2)   43 
[1] The number of participants assigned to each treatment cohort within the single arm of this study.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Objective Response Rate   [ Time Frame: 3 years ]

2.  Primary:   Response Rate Categorized by p63/p73 Ratio   [ Time Frame: 3 years ]

3.  Secondary:   Objective Response Rate Categorized by Subgroup   [ Time Frame: 3 years ]

4.  Secondary:   Progression Free Survival and Overall Survival   [ Time Frame: 5 years ]


  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: Steven Isakoff, MD, PhD
Organization: Massachusetts General Hospital
phone: 617-726-4920
e-mail: SISAKOFF@mgh.harvard.edu


Publications:

Responsible Party: Steven Isakoff, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00483223     History of Changes
Other Study ID Numbers: 06-412
TBCRC009 ( Other Identifier: Translational Breast Cancer Research Consortium )
Study First Received: June 5, 2007
Results First Received: April 13, 2017
Last Updated: May 25, 2017