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

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.
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Protocol Open to Accrual 10/25/2007 Primary Compeltion Date 02/22/2011 Recruitment Location is medical clinic

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
Treatment (Enzyme Inhibitor Therapy) Patients receive saracatinib 175 mg PO on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Participant Flow:   Overall Study
    Treatment (Enzyme Inhibitor Therapy)
STARTED   12 
COMPLETED   9 
NOT COMPLETED   3 
Not treated, patient ineligible                3 



  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
Treatment (Saracatinib) Patients will receive AZD0530 175mg orally daily for 4 weeks.

Baseline Measures
   Treatment (Saracatinib) 
Overall Participants Analyzed 
[Units: Participants]
 12 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   9 
>=65 years   3 
Age 
[Units: Years]
Mean (Standard Deviation)
 57  (38.18376618) 
Gender 
[Units: Participants]
 
Female   12 
Male   0 
Region of Enrollment 
[Units: Participants]
 
United States   12 


  Outcome Measures

1.  Primary:   Disease Control Rate (DCR)   [ Time Frame: After 24 weeks of study therapy ]

2.  Secondary:   Overall Response Rate (CR and PR)   [ Time Frame: From start of treatment to 24 weeks after completion of study treatment ]

3.  Secondary:   Median Time to Treatment Failure   [ Time Frame: From the start of treatment up to 4 weeks after completion of study treatment ]


  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:  
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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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
e-mail: hudisc@mskcc.org



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