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Phase II Study of AZD2281 in Patients With Known BRCA Mutation Status or Recurrent High Grade Ovarian Cancer or Patients With Known BRCA Mutation Status/ Triple Neg Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
British Columbia Cancer Agency
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00679783
First received: May 15, 2008
Last updated: September 2, 2014
Last verified: September 2014
Results First Received: July 19, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Ovarian Carcinoma
Breast Cancer
Intervention: Drug: AZD2281

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The first patient was enrolled on July 8, 2008 and efficacy and safety data were collected up to the data cut-off of March 26, 2010. Patients were enrolled at 6 centres in Canada. Of the 112 patients who gave informed consent 21 patients failed eligibility criteria or withdrew their consent and were not allocated to treatment.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study enrolled both known BRCA mutation carriers and patients with unknown BRCA status. Those with unknown status at entry had to provide a DNA sample for BRCA. One participant in arm 4 discontinued before receiving study drug and is excluded from the safety analysis set mutation analysis. Study data are summarised by confirmed mutation status.

Reporting Groups
  Description
BRCA Positive Non-serous Ovarian Patients with non-serous ovarian cancer who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as "non-serous" in this study).
BRCA Positive Serous Ovarian Patients with serous ovarian cancer who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer).
BRCA Negative Non-serous Ovarian Patients with non-serous ovarian cancer who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2
BRCA Negative Serous Ovarian Patients with serous ovarian cancer who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2
BRCA Positive Non-triple Negative Breast Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2
BRCA Positive Triple Negative Breast Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. TNBC are cancers that don’t have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don’t work for TNBC)
BRCA Negative Triple Negative Breast Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2.

Participant Flow:   Overall Study
    BRCA Positive Non-serous Ovarian     BRCA Positive Serous Ovarian     BRCA Negative Non-serous Ovarian     BRCA Negative Serous Ovarian     BRCA Positive Non-triple Negative Breast     BRCA Positive Triple Negative Breast     BRCA Negative Triple Negative Breast  
STARTED     4 [1]   13 [1]   3 [1]   45 [1]   5 [1]   5 [1]   16 [1]
COMPLETED     2 [2]   10 [2]   2 [2]   25 [2]   4 [2]   5 [2]   15 [2]
NOT COMPLETED     2     3     1     20     1     0     1  
Adverse Event                 0                 0                 0                 3                 0                 0                 1  
Lack of Efficacy                 0                 1                 0                 2                 0                 0                 0  
Withdrawal by Subject                 0                 0                 1                 1                 0                 0                 0  
Not Captured                 0                 0                 0                 5                 0                 0                 0  
Ongoing at data cut-off                 2                 2                 0                 9                 1                 0                 0  
[1] Gave Informed consent and passed screening
[2] Patients who discontinued treatment following disease progression.



  Baseline Characteristics
  Hide 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
BRCA Positive Non-serous Ovarian Patients with non-serous ovarian cancer who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as "non-serous" in this study).
BRCA Positive Serous Ovarian Patients with serous ovarian cancer who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer).
BRCA Negative Non-serous Ovarian Patients with non-serous ovarian cancer who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2
BRCA Negative Serous Ovarian Patients with serous ovarian cancer who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2
BRCA Positive Non-triple Negative Breast Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2
BRCA Positive Triple Negative Breast Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. TNBC are cancers that don’t have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don’t work for TNBC)
BRCA Negative Triple Negative Breast Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2.
Total Total of all reporting groups

Baseline Measures
    BRCA Positive Non-serous Ovarian     BRCA Positive Serous Ovarian     BRCA Negative Non-serous Ovarian     BRCA Negative Serous Ovarian     BRCA Positive Non-triple Negative Breast     BRCA Positive Triple Negative Breast     BRCA Negative Triple Negative Breast     Total  
Number of Participants  
[units: participants]
  4     13     3     44     5     5     16     90  
Age  
[units: Year]
Mean ± Standard Deviation
  60  ± 18.7     53.7  ± 7.3     60.3  ± 12.9     61  ± 9.5     49.4  ± 20.5     44.8  ± 15.5     48.8  ± 5.5     52.9  ± 13  
Gender  
[units: Participants]
               
Female     4     13     3     44     5     5     16     90  
Male     0     0     0     0     0     0     0     0  



  Outcome Measures
  Hide All Outcome Measures

1.  Primary:   Objective Response Rate (ORR) Evaluated According to Response Evaluation Criteria In Solid Tumors (RECIST) Guidelines   [ Time Frame: Each patient with measurable disease at baseline was assessed for Objective Response from the sequence of RECIST scan data up to data cut-off, 26 March 2010. RECIST scans were performed every 8 weeks (+/- 2 weeks) from randomization. ]

Measure Type Primary
Measure Title Objective Response Rate (ORR) Evaluated According to Response Evaluation Criteria In Solid Tumors (RECIST) Guidelines
Measure Description Percentage of participants with confirmed best RECIST response of complete response (CR) or partial response (PR). Patients with a best RECIST response of CR or PR had to have a confirmed response at least 28 days later.
Time Frame Each patient with measurable disease at baseline was assessed for Objective Response from the sequence of RECIST scan data up to data cut-off, 26 March 2010. RECIST scans were performed every 8 weeks (+/- 2 weeks) from randomization.  
Safety Issue No  

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
BRCA Positive Non-serous Ovarian Patients with non-serous ovarian cancer who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as "non-serous" in this study).
BRCA Positive Serous Ovarian Patients with serous ovarian cancer who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer).
BRCA Negative Non-serous Ovarian Patients with non-serous ovarian cancer who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2
BRCA Negative Serous Ovarian Patients with serous ovarian cancer who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2
BRCA Positive Non-triple Negative Breast Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2
BRCA Positive Triple Negative Breast Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. TNBC are cancers that don’t have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don’t work for TNBC)
BRCA Negative Triple Negative Breast Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2.

Measured Values
    BRCA Positive Non-serous Ovarian     BRCA Positive Serous Ovarian     BRCA Negative Non-serous Ovarian     BRCA Negative Serous Ovarian     BRCA Positive Non-triple Negative Breast     BRCA Positive Triple Negative Breast     BRCA Negative Triple Negative Breast  
Number of Participants Analyzed  
[units: participants]
  4     13     3     43     4     4     15  
Objective Response Rate (ORR) Evaluated According to Response Evaluation Criteria In Solid Tumors (RECIST) Guidelines  
[units: Percentage of participants]
Number ( 95% Confidence Interval )
  75  
  ( 30.06 to 95.44 )  
  30.77  
  ( 12.68 to 57.63 )  
  0  
  ( 0 to 56.15 )  
  25.58  
  ( 14.93 to 40.24 )  
  0  
  ( 0 to 48.99 )  
  0  
  ( 0 to 48.99 )  
  0  
  ( 0 to 20.39 )  

No statistical analysis provided for Objective Response Rate (ORR) Evaluated According to Response Evaluation Criteria In Solid Tumors (RECIST) Guidelines



2.  Secondary:   Disease Control Rate (DCR)   [ Time Frame: 16 Weeks ]

Measure Type Secondary
Measure Title Disease Control Rate (DCR)
Measure Description Percentage of participants with confirmed best Response Evaluation Criteria In Solid Tumours (RECIST) response of complete response (CR), partial response (PR) orStable Disease (SD)
Time Frame 16 Weeks  
Safety Issue No  

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
BRCA Positive Non-serous Ovarian Patients with non-serous ovarian cancer who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as "non-serous" in this study).
BRCA Positive Serous Ovarian Patients with serous ovarian cancer who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer).
BRCA Negative Non-serous Ovarian Patients with non-serous ovarian cancer who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2
BRCA Negative Serous Ovarian Patients with serous ovarian cancer who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2
BRCA Positive Non-triple Negative Breast Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2
BRCA Positive Triple Negative Breast Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. TNBC are cancers that don’t have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don’t work for TNBC)
BRCA Negative Triple Negative Breast Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2.

Measured Values
    BRCA Positive Non-serous Ovarian     BRCA Positive Serous Ovarian     BRCA Negative Non-serous Ovarian     BRCA Negative Serous Ovarian     BRCA Positive Non-triple Negative Breast     BRCA Positive Triple Negative Breast     BRCA Negative Triple Negative Breast  
Number of Participants Analyzed  
[units: participants]
  4     13     3     44     5     5     16  
Disease Control Rate (DCR)  
[units: Percentage of participants]
Number ( 95% Confidence Interval )
  75  
  ( 30.06 to 95.44 )  
  53.85  
  ( 29.14 to 76.79 )  
  0  
  ( 0 to 56.15 )  
  47.73  
  ( 33.75 to 62.06 )  
  60  
  ( 23.07 to 88.24 )  
  20  
  ( 3.62 to 62.45 )  
  0  
  ( 0 to 19.36 )  

No statistical analysis provided for Disease Control Rate (DCR)



3.  Secondary:   Duration of Response   [ Time Frame: RECIST tumour assessments carried out every 8 weeks from randomization (+/- 2 weeks) until data cut-off on 26 March 2010. ]

Measure Type Secondary
Measure Title Duration of Response
Measure Description Duration of response is measured from the time the measurement criteria for CR or PR are met (whichever is first recorded) until the patient progresses (per RECIST criteria). If patient did not progress, they are censored at their last objective tumour assessment date.
Time Frame RECIST tumour assessments carried out every 8 weeks from randomization (+/- 2 weeks) until data cut-off on 26 March 2010.  
Safety Issue No  

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
BRCA Positive Non-serous Ovarian Patients with non-serous ovarian cancer who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as "non-serous" in this study).
BRCA Positive Serous Ovarian Patients with serous ovarian cancer who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer).
BRCA Negative Non-serous Ovarian Patients with non-serous ovarian cancer who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2
BRCA Negative Serous Ovarian Patients with serous ovarian cancer who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2
BRCA Positive Non-triple Negative Breast Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2
BRCA Positive Triple Negative Breast Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. TNBC are cancers that don’t have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don’t work for TNBC)
BRCA Negative Triple Negative Breast Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2.

Measured Values
    BRCA Positive Non-serous Ovarian     BRCA Positive Serous Ovarian     BRCA Negative Non-serous Ovarian     BRCA Negative Serous Ovarian     BRCA Positive Non-triple Negative Breast     BRCA Positive Triple Negative Breast     BRCA Negative Triple Negative Breast  
Number of Participants Analyzed  
[units: participants]
  3     4     0     11     0     0     0  
Duration of Response  
[units: Days]
Median ( Full Range )
  277  
  ( 261 to 504 )  
  113  
  ( 109 to 446 )  
   
   
  384  
  ( 105 to 396 )  
   
   
   
   
   
   

No statistical analysis provided for Duration of Response



4.  Secondary:   Best Percentage Change From Baseline in Tumour Size   [ Time Frame: Each patient with measurable disease at baseline was assessed for best percentage change in tumour size from the sequence of RECIST scan data up to data cut-off, 26 March 2010. RECIST scans were performed every 8 weeks (+/- 2 weeks) from randomization. ]

Measure Type Secondary
Measure Title Best Percentage Change From Baseline in Tumour Size
Measure Description The best percentage change (reduction) from baseline in tumour size (defined as the sum of the longest diameters as measured among all target lesions).
Time Frame Each patient with measurable disease at baseline was assessed for best percentage change in tumour size from the sequence of RECIST scan data up to data cut-off, 26 March 2010. RECIST scans were performed every 8 weeks (+/- 2 weeks) from randomization.  
Safety Issue No  

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
BRCA Positive Non-serous Ovarian Patients with non-serous ovarian cancer who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as "non-serous" in this study).
BRCA Positive Serous Ovarian Patients with serous ovarian cancer who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer).
BRCA Negative Non-serous Ovarian Patients with non-serous ovarian cancer who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2
BRCA Negative Serous Ovarian Patients with serous ovarian cancer who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2
BRCA Positive Non-triple Negative Breast Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2
BRCA Positive Triple Negative Breast Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. TNBC are cancers that don’t have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don’t work for TNBC)
BRCA Negative Triple Negative Breast Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2.

Measured Values
    BRCA Positive Non-serous Ovarian     BRCA Positive Serous Ovarian     BRCA Negative Non-serous Ovarian     BRCA Negative Serous Ovarian     BRCA Positive Non-triple Negative Breast     BRCA Positive Triple Negative Breast     BRCA Negative Triple Negative Breast  
Number of Participants Analyzed  
[units: participants]
  4     13     2     38     4     4     14  
Best Percentage Change From Baseline in Tumour Size  
[units: Percentage]
Median ( Full Range )
  -44.5  
  ( -64 to 4 )  
  -21.6  
  ( -100 to 16 )  
  33.6  
  ( 14 to 53 )  
  -14.1  
  ( -95 to 83 )  
  -35.3  
  ( -48 to 10 )  
  -36.4  
  ( -50 to 11 )  
  21.3  
  ( -3 to 50 )  

No statistical analysis provided for Best Percentage Change From Baseline in Tumour Size



5.  Secondary:   CA-125 Levels (Ovarian Cancer Patients Only)   [ Time Frame: 24 weeks ]

Measure Type Secondary
Measure Title CA-125 Levels (Ovarian Cancer Patients Only)
Measure Description A response according to CA-125 has occurred if there is at least a 50% reduction in CA-125 levels from a pre-treatment sample.
Time Frame 24 weeks  
Safety Issue No  

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
BRCA Positive Non-serous Ovarian Patients with non-serous ovarian cancer who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as "non-serous" in this study).
BRCA Positive Serous Ovarian Patients with serous ovarian cancer who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer).
BRCA Negative Non-serous Ovarian Patients with non-serous ovarian cancer who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2
BRCA Negative Serous Ovarian Patients with serous ovarian cancer who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2
BRCA Positive Non-triple Negative Breast Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2
BRCA Positive Triple Negative Breast Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. TNBC are cancers that don’t have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don’t work for TNBC)
BRCA Negative Triple Negative Breast Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2.

Measured Values
    BRCA Positive Non-serous Ovarian     BRCA Positive Serous Ovarian     BRCA Negative Non-serous Ovarian     BRCA Negative Serous Ovarian     BRCA Positive Non-triple Negative Breast     BRCA Positive Triple Negative Breast     BRCA Negative Triple Negative Breast  
Number of Participants Analyzed  
[units: participants]
  4     12     3     35     0     0     0  
CA-125 Levels (Ovarian Cancer Patients Only)  
[units: Percentage of participants]
Number ( 95% Confidence Interval )
  75  
  ( 30.06 to 95.44 )  
  33.33  
  ( 13.81 to 60.94 )  
  0  
  ( 0 to 56.15 )  
  28.57  
  ( 16.33 to 45.05 )  
   
   
   
   
   
   

No statistical analysis provided for CA-125 Levels (Ovarian Cancer Patients Only)



6.  Secondary:   Progression Free Survival (PFS)   [ Time Frame: RECIST tumour assessments carried out every 8 weeks from randomization (+/- 2 weeks) until data cut-off on 26 March 2010. ]

Measure Type Secondary
Measure Title Progression Free Survival (PFS)
Measure Description PFS is defined as the time from first dose to the earlier date of radiologic progression (as per Response Evaluation Criteria In Solid Tumours (RECIST) criteria or death by any cause in the absence of objective progression.
Time Frame RECIST tumour assessments carried out every 8 weeks from randomization (+/- 2 weeks) until data cut-off on 26 March 2010.  
Safety Issue No  

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
BRCA Positive Non-serous Ovarian Patients with non-serous ovarian cancer who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as "non-serous" in this study).
BRCA Positive Serous Ovarian Patients with serous ovarian cancer who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer).
BRCA Negative Non-serous Ovarian Patients with non-serous ovarian cancer who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2
BRCA Negative Serous Ovarian Patients with serous ovarian cancer who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2
BRCA Positive Non-triple Negative Breast Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2
BRCA Positive Triple Negative Breast Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. TNBC are cancers that don’t have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don’t work for TNBC)
BRCA Negative Triple Negative Breast Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2.

Measured Values
    BRCA Positive Non-serous Ovarian     BRCA Positive Serous Ovarian     BRCA Negative Non-serous Ovarian     BRCA Negative Serous Ovarian     BRCA Positive Non-triple Negative Breast     BRCA Positive Triple Negative Breast     BRCA Negative Triple Negative Breast  
Number of Participants Analyzed  
[units: participants]
  4     13     3     44     5     5     16  
Progression Free Survival (PFS)  
[units: Days]
Median ( Full Range )
  346.5  
  ( 51 to 553 )  
  219  
  ( 1 to 503 )  
  79.5  
  ( 1 to 109 )  
  192  
  ( 1 to 559 )  
  165  
  ( 53 to 168 )  
  106  
  ( 37 to 277 )  
  54  
  ( 1 to 111 )  

No statistical analysis provided for Progression Free Survival (PFS)




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
  Hide 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: Gerard Lynch
Organization: AstraZeneca
e-mail: aztrial_results_posting@astrazeneca.com


No publications provided by AstraZeneca

Publications automatically indexed to this study:

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00679783     History of Changes
Other Study ID Numbers: D0810C00020
Study First Received: May 15, 2008
Results First Received: July 19, 2011
Last Updated: September 2, 2014
Health Authority: Canada: Health Canada