Pazopanib in Combination With Capecitabine in Patients With Metastatic Breast Cancer (PazoX)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
German Breast Group
ClinicalTrials.gov Identifier:
NCT01498458
First received: December 21, 2011
Last updated: September 17, 2014
Last verified: September 2014
Results First Received: July 4, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Metastatic Breast Cancer
Intervention: Drug: Pazopanib plus capecitabine

  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
9 patients were registered in the study but patient number 9 withdrew consent immediately without receiving any Pazopanib.

Reporting Groups
  Description
Pazopanib Plus Capecitabine The baseline refers only to the 8 patients who received Pazopanib.

Participant Flow:   Overall Study
    Pazopanib Plus Capecitabine  
STARTED     8 [1]
COMPLETED     1 [2]
NOT COMPLETED     7  
Adverse Event                 4  
Physician Decision                 3  
[1] 9 patients took part in the study of which 8 received pazopanib.
[2] only 1 patient was in the study at the end. 7 left due to Adverse Events or Investigators Decision.



  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
Pazopanib Plus Capecitabine pazopanib plus capecitabine

Baseline Measures
    Pazopanib Plus Capecitabine  
Number of Participants  
[units: participants]
  8  
Age, Customized  
[units: participants]
 
premenopausal     1  
Postmenopausal     7  
Gender  
[units: participants]
 
Female     8  
Male     0  
ECOG [1]
[units: participants]
 
ECOG 0     6  
ECOG 1     2  
T status [2]
[units: participants]
 
T1     2  
T2     3  
T3     0  
T4     2  
Tis     1  
N Status [3]
[units: participants]
 
N0     2  
N1     5  
N2     0  
N3     1  
Grading [4]
[units: participants]
 
G1     0  
G2     5  
G3     3  
Hormone Receptor Status  
[units: participants]
 
ERneg/PRneg     2  
ERneg/PRpos     1  
ERpos/PRneg     2  
ERpos/PRpos     3  
HER2 Status  
[units: participants]
 
Her2 Negative     8  
Her2 Positive     0  
[1]

ECOG Status refers to the Eastern Cooperative Oncology Group scale . These scales and criteria are used by doctors and researchers to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis...Grade 0 Fully active

  • Grade 1 restricted in physically strenuous activity
  • Grade 2 Ambulatory and capable of all selfcare
  • Grade 3 Capable of only limited selfcare
  • Grade 4 Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair
  • Grade 5 Dead
[2] T status describes the size of the original (primary) tumor and whether it has invaded nearby tissue,,,T1 – The tumour is 2 centimetres (cm) across or less...T2 – The tumour is more than 2 centimetres, but no more than 5 centimetres across...T3 – The tumour is bigger than 5 centimetres across...T4 refers to inflamatory breast cancer....Tis means DCIS(ductal carcinoma in situ...The tumors are all breast cancer tumors as the study has to do with breast cancer.
[3] N status is a categorisation of the number of lymph nodes..N0 – No cancer cells found in any nearby nodes...N1 is when 1 to 3 lymph nodes are found.....N2 is when 4 to 9 lymph nodes are found....N2 is when greater than 9 lymph nodes are found
[4]

Grading is a measure of the cell appearance in tumors and other neoplasms in pathology...Grade 1 Well differentiated (Low grade)...

Grade 2 Moderately differentiated (Intermediate grade)... Grade 3 poorly differentiated (High grade)




  Outcome Measures
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1.  Primary:   Maximum Tolerable Dose (MTD) of Pazopanib   [ Time Frame: 3 years ]

2.  Secondary:   Dose-limiting Toxicity (DLT)   [ Time Frame: 3 years ]

3.  Secondary:   Hematological Toxicity of the Combination of Pazopanib and Capecitabine   [ Time Frame: 3 years ]

4.  Secondary:   Other Toxicity of the Combination of Pazopanib and Capecitabine   [ Time Frame: 3 years ]

5.  Secondary:   Objective Response Rate (ORR)   [ Time Frame: 3 years ]

6.  Secondary:   Clinical Benefit Rate (CBR)   [ Time Frame: 3 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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Andreas Schneeweiss
Organization: University Hospital Heidelberg
phone: +49 (0)6221 56 36051
e-mail: andreas.schneeweiss@med.uni-heidelberg.de


No publications provided


Responsible Party: German Breast Group
ClinicalTrials.gov Identifier: NCT01498458     History of Changes
Other Study ID Numbers: GBG 62, 2010-019510-25
Study First Received: December 21, 2011
Results First Received: July 4, 2014
Last Updated: September 17, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices