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Saracatinib in Treating Patients With Metastatic or Locally Advanced Breast Cancer That Cannot Be Removed By Surgery

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ClinicalTrials.gov Identifier: NCT00559507
Recruitment Status : Completed
First Posted : November 16, 2007
Results First Posted : January 20, 2014
Last Update Posted : April 30, 2014
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Estrogen Receptor-negative Breast Cancer
Male Breast Cancer
Progesterone Receptor-negative Breast Cancer
Recurrent Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Stage IV Breast Cancer
Interventions Drug: saracatinib
Other: laboratory biomarker analysis
Enrollment 12
Recruitment Details Protocol Open to Accrual 10/25/2007 Primary Compeltion Date 02/22/2011 Recruitment Location is medical clinic
Pre-assignment Details  
Arm/Group Title Treatment (Enzyme Inhibitor Therapy)
Hide Arm/Group Description Patients receive saracatinib 175 mg PO on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Period Title: Overall Study
Started 12
Completed 9
Not Completed 3
Reason Not Completed
Not treated, patient ineligible             3
Arm/Group Title Treatment (Saracatinib)
Hide Arm/Group Description Patients will receive AZD0530 175mg orally daily for 4 weeks.
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
<=18 years
0
   0.0%
Between 18 and 65 years
9
  75.0%
>=65 years
3
  25.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants
57  (38.18376618)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
12
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants
12
1.Primary Outcome
Title Disease Control Rate (DCR)
Hide Description DCR defined as complete response (CR), partial response (PR), stable disease (SD) > 24 weeks. Simon’s two-stage optimal design was used to estimate the DCR of AZD0530 after 24 weeks of therapy since this design allowed for early termination of the study. Response and progression was evaluated in this study using the Response Evaluation Criteria in Solid Tumors (RECIST) Target lesions: Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started
Time Frame After 24 weeks of study therapy
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Enzyme Inhibitor Therapy)
Hide Arm/Group Description:
Patients receive saracatinib PO on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: participants
0
2.Secondary Outcome
Title Overall Response Rate (CR and PR)
Hide Description Overall Response rate is defined as the sum of the complete response rate and partial response rate. Response and progression was evaluated in this study using the Response Evaluation Criteria in Solid Tumors (RECIST) Target lesions: Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started
Time Frame From start of treatment to 24 weeks after completion of study treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Enzyme Inhibitor Therapy)
Hide Arm/Group Description:
Patients receive saracatinib PO on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: participants
Stable Disease 3
Progression of Disease 6
3.Secondary Outcome
Title Median Time to Treatment Failure
Hide Description [Not Specified]
Time Frame From the start of treatment up to 4 weeks after completion of study treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Enzyme Inhibitor Therapy)
Hide Arm/Group Description:
Patients receive saracatinib PO on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 9
Median (Full Range)
Unit of Measure: Days
82
(12 to 109)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Enzyme Inhibitor Therapy)
Hide Arm/Group Description Patients receive saracatinib PO on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
All-Cause Mortality
Treatment (Enzyme Inhibitor Therapy)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Enzyme Inhibitor Therapy)
Affected / at Risk (%) # Events
Total   3/9 (33.33%)    
Blood and lymphatic system disorders   
Hypoxia  1  1/9 (11.11%)  1
General disorders   
Fatigue (asthenia, lethargy, malaise)  1  1/9 (11.11%)  1
Adrenal insufficiency  1  1/9 (11.11%)  1
Sodium, low (hyponatremia)  1  1/9 (11.11%)  1
Hepatobiliary disorders   
Elevated liver enzymes  1  1/9 (11.11%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE 3.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment (Enzyme Inhibitor Therapy)
Affected / at Risk (%) # Events
Total   7/9 (77.78%)    
Blood and lymphatic system disorders   
AST, SGOT  1  2/9 (22.22%)  2
Neutrophils/granulocytes (ANC/AGC)  1  1/9 (11.11%)  1
Hemoglobin  1  1/9 (11.11%)  1
General disorders   
Glucose, high (hyperglycemia)  1  1/9 (11.11%)  1
Potassium, low (hypokalemia)  1  1/9 (11.11%)  1
Phosphate, low (hypophosphatemia)  1  2/9 (22.22%)  2
Bilirubin  1  1/9 (11.11%)  1
Metabolism and nutrition disorders   
Fatigue  1  1/9 (11.11%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea (shortness of breath)  1  1/9 (11.11%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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: Clifford Hudis, MD
Organization: Memorial Sloan-Kettering Cancer Center
Phone: 646-888-4551
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00559507     History of Changes
Obsolete Identifiers: NCT01645605, NCT01664481
Other Study ID Numbers: NCI-2009-00191
MSKCC-07112
N01CM62204 ( U.S. NIH Grant/Contract )
N01CM62206 ( U.S. NIH Grant/Contract )
CDR0000574281 ( Registry Identifier: PDQ (Physician Database Query) )
First Submitted: November 15, 2007
First Posted: November 16, 2007
Results First Submitted: August 14, 2013
Results First Posted: January 20, 2014
Last Update Posted: April 30, 2014