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Assessment of the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations. (OlympiAD)

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ClinicalTrials.gov Identifier: NCT02000622
Recruitment Status : Active, not recruiting
First Posted : December 4, 2013
Results First Posted : December 22, 2017
Last Update Posted : June 26, 2018
Sponsor:
Collaborators:
Myriad Genetic Laboratories, Inc.
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
AstraZeneca

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Breast Cancer Metastatic
BRCA 1 Gene Mutation
BRCA 2 Gene Mutation
Interventions: Drug: Olaparib
Drug: Physician's choice chemotherapy

  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 27 March 2014 and the last patient on 30 October 2015. Patients were randomised at 125 centres across 19 countries in North America, South America, Europe and Asia.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Screening occurred in 2 parts. Part 1: patients with unknown BRCA status were tested by Myriad. Part 1 screening failures were mostly due to no BRCA1/2 mutation detected. Part 2: patients with known BRCA status were screened. 302 patients were randomised.

Reporting Groups
  Description
Olaparib 300 mg bd Olaparib 300 mg bd tablets
Chemotherapy Physician's choice of chemotherapy; capecitabine, vinorelbine, or eribulin

Participant Flow:   Overall Study
    Olaparib 300 mg bd   Chemotherapy
STARTED   205   97 
COMPLETED   104 [1]   44 [1] 
NOT COMPLETED   101   53 
Withdrawn due to site closure                1                0 
Lost to Follow-up                1                0 
Death                94                46 
Withdrawal by Subject                5                7 
[1] Patients were ongoing on the study at the data cut-off.



  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.
Full analyis set consisting of all randomised patients

Reporting Groups
  Description
Olaparib 300 mg bd Olaparib 300 mg bd tablets
Chemotherapy Physician's choice of chemotherapy; capecitabine, vinorelbine, or eribulin
Total Total of all reporting groups

Baseline Measures
   Olaparib 300 mg bd   Chemotherapy   Total 
Overall Participants Analyzed 
[Units: Participants]
 205   97   302 
Age [1] 
[Units: Years]
Median (Full Range)
     
Age (years)   44 
 (22 to 76) 
 45 
 (24 to 68) 
 44 
 (22 to 76) 
[1] Full analysis set consisting of all randomised patients
Sex: Female, Male [1] 
[Units: Participants]
Count of Participants
     
Female      200  97.6%      95  97.9%      295  97.7% 
Male      5   2.4%      2   2.1%      7   2.3% 
[1] Full analysis set consisting of all randomised patients
Race (NIH/OMB) [1] 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      3   1.5%      1   1.0%      4   1.3% 
Asian      66  32.2%      28  28.9%      94  31.1% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      1   0.5%      4   4.1%      5   1.7% 
White      134  65.4%      63  64.9%      197  65.2% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      1   0.5%      1   1.0%      2   0.7% 
[1] Full analysis set consisting of all randomised patients
Receptor status [1] [2] 
[Units: Participants]
Count of Participants
     
ER and/or PgR positive      103  50.2%      49  50.5%      152  50.3% 
ER and PgR negative      102  49.8%      48  49.5%      150  49.7% 
[1] ER = oestrogen receptor; PgR = progesterone receptor; All patients were HER2 negative.
[2] Full analysis set consisting of all randomised patients
Received prior chemotherapy for metastatic breast cancer [1] 
[Units: Participants]
Count of Participants
     
Yes      146  71.2%      69  71.1%      215  71.2% 
No      59  28.8%      28  28.9%      87  28.8% 
[1] Full analysis set consisting of all randomised patients
Received prior platinum for breast cancer [1] 
[Units: Participants]
Count of Participants
     
Yes      60  29.3%      26  26.8%      86  28.5% 
No      145  70.7%      71  73.2%      216  71.5% 
[1] Full analysis set consisting of all randomised patients


  Outcome Measures

1.  Primary:   Progression-free Survival (PFS) Using Blinded Independent Central Review (BICR) According to Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1)   [ Time Frame: Radiological scans performed at baseline then every ~6 weeks up to 24 weeks, then every ~ 12 weeks thereafter until objective radiological disease progression. Assessed up to a maximum of 30 months. ]

2.  Secondary:   Time to Second Progression or Death (PFS2)   [ Time Frame: Second progression status reviewed every 8 weeks following the first objective radiological progression as per investigator assessment. Assessed up to a maximum of 30 months. ]

3.  Secondary:   Overall Survival (OS)   [ Time Frame: Survival status reviewed every 3 weeks until treatment discontinued, then every 8 weeks. Assessed up to a maximum of 30 months. ]

4.  Secondary:   Objective Response Rate (ORR) Using Blinded Independent Central Review (BICR) Data Assessed by Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1)   [ Time Frame: Radiological scans performed at baseline then every ~6 weeks up to 24 weeks, then every ~ 12 weeks thereafter until objective radiological disease progression. Assessed up to a maximum of 30 months. ]

5.  Secondary:   Adjusted Mean Change in Global Health Status/Quality of Life (QoL) Score From the European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire (EORTC QLQ-C30)   [ Time Frame: EORTC QLQ-C30 assessments performed at baseline then every ~6 weeks until objective radiological disease progression. Assessed up to a maximum of 30 months. ]

6.  Secondary:   Progression-free Survival (PFS) Using Blinded Independent Central Review (BICR) According to Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1) in Patients Confirmed as Myriad CDx gBRCAm   [ Time Frame: Radiological scans performed at baseline then every ~6 weeks up to 24 weeks, then every ~ 12 weeks thereafter until objective radiological disease progression. Assessed up to a maximum of 30 months. ]

7.  Other Pre-specified:   Time to First Subsequent Cancer Therapy or Death (TFST)   [ Time Frame: Subsequent cancer therapy status reviewed every 8 weeks following study treatment discontinuation. Assessed up to a maximum of 30 months. ]

8.  Other Pre-specified:   Time to Second Subsequent Cancer Therapy or Death (TSST)   [ Time Frame: Subsequent cancer therapy status reviewed every 8 weeks following study treatment discontinuation. Assessed up to a maximum of 30 months. ]


  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
The OS data were 46% mature but there was no indication of an OS detriment. Another analysis of OS will be performed at approximately 60% maturity.


  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 less than or equal to 60 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: Medical Science Director
Organization: AstraZeneca
e-mail: clinicaltrialtransparency@astrazeneca.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02000622     History of Changes
Other Study ID Numbers: D0819C00003
2013-005137-20 ( EudraCT Number )
First Submitted: November 18, 2013
First Posted: December 4, 2013
Results First Submitted: November 28, 2017
Results First Posted: December 22, 2017
Last Update Posted: June 26, 2018