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    Clinical Trial Results:
    A Phase IIIb, Single-arm, Open-label Multicentre Study of Olaparib Monotherapy in the Treatment of HER2-ve Metastatic Breast Cancer Patients with Germline or Somatic BRCA1/2 Mutations

    Summary
    EudraCT number
    		 2017-001054-34
    Trial protocol
    		 DE   GB   ES   HU   FR   PL   BG   IT  
    Global end of trial date
    08 Oct 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Oct 2022
    First version publication date
    25 Oct 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    D0816C00018
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03286842
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca Clinical Study Information Center
    Sponsor organisation address
    NA, NA, United States, NA
    Public contact
    Global Clinical Lead, AstraZeneca Clinical Study Information Center, +1 8772409479, information.center@astrazeneca.com
    Scientific contact
    Global Clinical Lead, AstraZeneca Clinical Study Information Center, +1 8772409479, information.center@astrazeneca.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    15 Oct 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Oct 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the clinical effectiveness of olaparib treatment in HER2-ve metastatic breast cancer patients in a real-world setting through assessment of progression-free survival in germline BRCA mutated patients
    Protection of trial subjects
    This study was performed in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with ICH/GCP, applicable regulatory requirements and the AstraZeneca policy on Bioethics.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Jan 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 13
    Country: Number of subjects enrolled
    United States: 2
    Country: Number of subjects enrolled
    France: 52
    Country: Number of subjects enrolled
    Italy: 43
    Country: Number of subjects enrolled
    Spain: 26
    Country: Number of subjects enrolled
    United Kingdom: 24
    Country: Number of subjects enrolled
    Turkey: 21
    Country: Number of subjects enrolled
    Russian Federation: 20
    Country: Number of subjects enrolled
    Germany: 15
    Country: Number of subjects enrolled
    Poland: 11
    Country: Number of subjects enrolled
    Bulgaria: 7
    Country: Number of subjects enrolled
    Hungary: 2
    Country: Number of subjects enrolled
    Korea, Republic of: 16
    Country: Number of subjects enrolled
    Japan: 2
    Country: Number of subjects enrolled
    Taiwan: 1
    Worldwide total number of subjects
    255
    EEA total number of subjects
    156
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    232
    From 65 to 84 years
    23
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled in this study from 17-January-2018 to 21-March-2019 in 125 sites in 15 countries.

    Pre-assignment
    Screening details
    		 Participants who met the inclusion and none of the exclusion criteria were enrolled to the study. All study assessments were performed as per the schedule of assessment.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Olaparib
    Arm description
    		 Participants received olaparib 300 mg tablets orally twice daily continuously given as 2 x 150 mg twice daily.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Olaparib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Peritumoral use
    Dosage and administration details
    Participants were administered olaparib 300 mg tablets orally twice daily continuously given as 2 x 150 mg twice daily.

    Number of subjects in period 1
    		Olaparib
    Started
    255
    Completed
    0
    Not completed
    255
         Participants ongoing in the study
    80
         Excluding COVID-19
    3
         Death
    142
         Withdrawal by participant
    28
         Lost to follow-up
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Olaparib
    Reporting group description
    		 Participants received olaparib 300 mg tablets orally twice daily continuously given as 2 x 150 mg twice daily.

    Reporting group values
    		 Olaparib Total
    Number of subjects
    		 255 255
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 232 232
        From 65-84 years
    		 23 23
        85 years and over
    		 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 46.3 ± 11.34 -
    Sex: Female, Male
    Units: Participants
        Female
    		 251 251
        Male
    		 4 4
    Race (NIH/OMB)
    Units: Subjects
        White
    		 177 177
        American Indian or Alaska Native
    		 1 1
        Asian
    		 23 23
        Black or African American
    		 2 2
        Native Hawaiian or Other Pacific Islander
    		 0 0
        Other
    		 0 0
        Missing
    		 52 52
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 13 13
        Not Hispanic or Latino
    		 190 190
        Missing
    		 52 52
    Subject analysis sets

    Subject analysis set title
    Olaparib gBRCAm cohort
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants received olaparib 300mg twice daily given as 150mg x 2 tablets orally twice daily continuously.

    Subject analysis set title
    Olaparib sBRCAm cohort
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants received olaparib 300mg twice daily given as 150mg x 2 tablets orally twice daily continuously.

    Subject analysis sets values
    		 Olaparib gBRCAm cohort Olaparib sBRCAm cohort
    Number of subjects
    252
    3
    Age categorical
    Units: Subjects
        In utero
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
        Newborns (0-27 days)
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
        Children (2-11 years)
    0
    0
        Adolescents (12-17 years)
    0
    0
        Adults (18-64 years)
    230
    2
        From 65-84 years
    22
    1
        85 years and over
    0
    0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    46.2 ± 11.30
    ±
    Sex: Female, Male
    Units: Participants
        Female
    248
    3
        Male
    4
    0
    Race (NIH/OMB)
    Units: Subjects
        White
    177
    0
        American Indian or Alaska Native
    1
    0
        Asian
    22
    1
        Black or African American
    2
    0
        Native Hawaiian or Other Pacific Islander
    0
    0
        Other
    0
    0
        Missing
    50
    2
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    13
    0
        Not Hispanic or Latino
    189
    1
        Missing
    50
    2

    End points

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    End points reporting groups
    Reporting group title
    Olaparib
    Reporting group description
    		 Participants received olaparib 300 mg tablets orally twice daily continuously given as 2 x 150 mg twice daily.

    Subject analysis set title
    Olaparib gBRCAm cohort
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants received olaparib 300mg twice daily given as 150mg x 2 tablets orally twice daily continuously.

    Subject analysis set title
    Olaparib sBRCAm cohort
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants received olaparib 300mg twice daily given as 150mg x 2 tablets orally twice daily continuously.

    Primary: Progression-free survival (PFS) in real-world setting in germline BRCA mutated participants

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    End point title
    		 Progression-free survival (PFS) in real-world setting in germline BRCA mutated participants [1]
    End point description
    The clinical effectiveness of olaparib treatment in HER2-ve metastatic breast cancer participants in a real-world setting through assessment of PFS in germline BRCA mutated patients was evaluated. PFS was defined as the time from first dose of olaparib to the date of progression or death from any cause regardless of whether the patient withdraws from therapy or receives another anticancer therapy prior to progression.
    End point type
    Primary
    End point timeframe
    At every visit until the earliest of disease progression, death or end of study (up to 3.9 years)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical Analyses were not performed for the outcome measures.
    End point values
    		 Olaparib
    Number of subjects analysed
    252
    Units: months
    median (confidence interval 95%)
        gBRCAm cohort
    8.18 (6.97 to 9.17)
    No statistical analyses for this end point

    Secondary: Overall survival (OS) in germline BRCA mutated participants

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    End point title
    		 Overall survival (OS) in germline BRCA mutated participants
    End point description
    The clinical effectiveness of olaparib treatment in HER2-ve metastatic breast cancer participants in a real-world setting by assessment of overall survival in germline BRCA mutated participants was determined. OS is defined as the time from first dose of olaparib to the date of death from any cause.
    End point type
    Secondary
    End point timeframe
    At every visit and until death or end of study (up to 3.9 years)
    End point values
    		 Olaparib
    Number of subjects analysed
    252
    Units: months
    median (confidence interval 95%)
        gBRCAm cohort
    24.94 (21.06 to 28.91)
    No statistical analyses for this end point

    Secondary: Time to first subsequent treatment or death (TFST) in germline BRCA mutated participants

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    End point title
    		 Time to first subsequent treatment or death (TFST) in germline BRCA mutated participants
    End point description
    The clinical effectiveness of olaparib treatment in HER2-ve metastatic breast cancer participants in a real-world setting by assessment of time to use of subsequent therapies, second progression, and study treatment discontinuation in germline BRCA mutated participants was determined. TFST is defined as the time from first dose of olaparib to first subsequent treatment commencement or death if this occurs before commencement of first subsequent treatment.
    End point type
    Secondary
    End point timeframe
    At every visit until start of first subsequent anticancer treatment or death or end of study (up to 3.9 years)
    End point values
    		 Olaparib
    Number of subjects analysed
    252
    Units: months
    median (confidence interval 95%)
        gBRCAm cohort
    9.40 (8.61 to 10.64)
    No statistical analyses for this end point

    Secondary: Time to second subsequent treatment or death (TSST) in germline BRCA mutated participants

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    End point title
    		 Time to second subsequent treatment or death (TSST) in germline BRCA mutated participants
    End point description
    The clinical effectiveness of olaparib treatment in HER2-ve metastatic breast cancer participants in a real-world setting by assessment of time to use of subsequent therapies, second progression, and study treatment discontinuation in germline BRCA mutated participants was determined. TSST is defined as the time from first dose of olaparib to second subsequent treatment commencement or death if this occurs before commencement of second subsequent treatment.
    End point type
    Secondary
    End point timeframe
    At every visit until start of second subsequent anticancer treatment or death or end of study (up to 3.9 years)
    End point values
    		 Olaparib
    Number of subjects analysed
    252
    Units: months
    median (confidence interval 95%)
        gBRCAm cohort
    14.72 (13.50 to 17.25)
    No statistical analyses for this end point

    Secondary: Time to study treatment discontinuation or death (TDT) in germline BRCA mutated participants

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    End point title
    		 Time to study treatment discontinuation or death (TDT) in germline BRCA mutated participants
    End point description
    The clinical effectiveness of olaparib treatment in HER2-ve metastatic breast cancer participants in a real-world setting by assessment of time to use of subsequent therapies, second progression, and study treatment discontinuation in germline BRCA mutated patients was determined. TDT is defined as the time from first dose of olaparib to study treatment discontinuation or death if this occurs before discontinuation of study treatment.
    End point type
    Secondary
    End point timeframe
    At every visit and until discontinuation of study treatment or death or end of study (up to 3.9 years)
    End point values
    		 Olaparib
    Number of subjects analysed
    252
    Units: months
    median (confidence interval 95%)
        gBRCAm cohort
    7.98 (6.90 to 8.54)
    No statistical analyses for this end point

    Secondary: Time to second progression or death (PFS2) in germline BRCA mutated participants

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    End point title
    		 Time to second progression or death (PFS2) in germline BRCA mutated participants
    End point description
    The clinical effectiveness of olaparib treatment in HER2-ve metastatic breast cancer participants in a real-world setting by assessment of time to use of subsequent therapies, second progression, and study treatment discontinuation in germline BRCA mutated participants was determined. PFS2 is defined as the time from first dose of olaparib to the earliest progression event subsequent to that used for the primary variable PFS or death from any cause.
    End point type
    Secondary
    End point timeframe
    At every visit until second progression or death or end of study (up to 3.9 years)
    End point values
    		 Olaparib
    Number of subjects analysed
    252
    Units: months
    median (confidence interval 95%)
        gBRCAm cohort
    14.49 (13.17 to 17.05)
    No statistical analyses for this end point

    Secondary: Clinical response rate (CRR) in germline BRCA mutated participants

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    End point title
    		 Clinical response rate (CRR) in germline BRCA mutated participants
    End point description
    The clinical effectiveness of olaparib treatment in HER2-ve metastatic breast cancer participants in a real-world setting by assessment of clinical response rate and duration of clinical response in germline BRCA mutated participants was determined. CRR is defined as the proportion of patients assessed by the Investigator as responding.
    End point type
    Secondary
    End point timeframe
    At every visit until disease progression or death or end of study (up to 3.9 years)
    End point values
    		 Olaparib
    Number of subjects analysed
    252
    Units: Percentage of participants
        number (confidence interval 95%)
    49.6 (43.3 to 55.9)
    No statistical analyses for this end point

    Secondary: Number of participants with adverse events (AEs) and serious adverse events (SAEs)

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    End point title
    		 Number of participants with adverse events (AEs) and serious adverse events (SAEs)
    End point description
    The safety and tolerability of olaparib treatment in HER2-ve metastatic breast cancer patients in a real-word setting was evaluated. LTD = leading to discontinuation CRT = causally related to treatment
    End point type
    Secondary
    End point timeframe
    From Screening (Day -28 to Day -1) until post DCO [up to 3.9 years]
    End point values
    		 Olaparib gBRCAm cohort
    Number of subjects analysed
    252
    Units: Participants
        Any AE
    243
        Any AE CRT
    214
        Any AE of CTCAE grade ≥ 3
    69
        Any AE of CTCAE grade ≥ 3, CRT
    44
        Any AE with outcome = death
    0
        Any AE with outcome = death, CRT
    0
        Any SAE (including death)
    32
        Any SAE (including death), CRT
    10
        Any AE LTD of study treatment
    16
        Any AE LTD of study treatment, CRT
    11
    No statistical analyses for this end point

    Secondary: Duration of clinical response (DoCR) in germline BRCA mutated participants

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    End point title
    		 Duration of clinical response (DoCR) in germline BRCA mutated participants
    End point description
    The clinical effectiveness of olaparib treatment in HER2-ve metastatic breast cancer participants in a real-world setting by assessment of clinical response rate and duration of clinical response in germline BRCA mutated participants was determined. DoCR is defined as the time from the date the Investigator first assessed the patient as responding to the date the Investigator assessed the patient as progressing or the date of death from any cause.
    End point type
    Secondary
    End point timeframe
    At every visit until disease progression or death or end of study (up to 3.9 years)
    End point values
    		 Olaparib
    Number of subjects analysed
    252
    Units: Months
    median (inter-quartile range (Q1-Q3))
        gBRCAm cohort
    8.0 (4.2 to 18.6)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Screening (Day -28 to -1) until post DCO [up to 3.9 years].
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Olaparib
    Reporting group description
    		 Participants received olaparib 150mg tablets orally twice daily continuously.

    Serious adverse events
    		 Olaparib
    Total subjects affected by serious adverse events
         subjects affected / exposed
    33 / 255 (12.94%)
         number of deaths (all causes)
    142
         number of deaths resulting from adverse events
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bladder cancer stage 0, with cancer in situ
         subjects affected / exposed
    1 / 255 (0.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Myelodysplastic syndrome
         subjects affected / exposed
    1 / 255 (0.39%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pancreatic carcinoma
         subjects affected / exposed
    1 / 255 (0.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    2 / 255 (0.78%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 255 (0.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 255 (0.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pleurisy
         subjects affected / exposed
    1 / 255 (0.39%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pleural effusion
         subjects affected / exposed
    1 / 255 (0.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lung disorder
         subjects affected / exposed
    1 / 255 (0.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 255 (0.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Psychiatric decompensation
         subjects affected / exposed
    1 / 255 (0.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Anxiety
         subjects affected / exposed
    1 / 255 (0.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Investigations
    General physical condition abnormal
         subjects affected / exposed
    1 / 255 (0.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Head injury
         subjects affected / exposed
    1 / 255 (0.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Radiation necrosis
         subjects affected / exposed
    1 / 255 (0.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    1 / 255 (0.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Spinal fracture
         subjects affected / exposed
    1 / 255 (0.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Pericardial effusion
         subjects affected / exposed
    1 / 255 (0.39%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Epilepsy
         subjects affected / exposed
    1 / 255 (0.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    7 / 255 (2.75%)
         occurrences causally related to treatment / all
    6 / 10
         deaths causally related to treatment / all
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    2 / 255 (0.78%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Pancytopenia
         subjects affected / exposed
    1 / 255 (0.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Ileus paralytic
         subjects affected / exposed
    1 / 255 (0.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vomiting
         subjects affected / exposed
    2 / 255 (0.78%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    1 / 255 (0.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 255 (0.39%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 255 (0.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bone pain
         subjects affected / exposed
    1 / 255 (0.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Muscle spasms
         subjects affected / exposed
    1 / 255 (0.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    1 / 255 (0.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    1 / 255 (0.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 255 (0.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Abscess
         subjects affected / exposed
    1 / 255 (0.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Chest wall abscess
         subjects affected / exposed
    1 / 255 (0.39%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 255 (0.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    H1N1 influenza
         subjects affected / exposed
    1 / 255 (0.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Device related infection
         subjects affected / exposed
    1 / 255 (0.39%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Skin infection
         subjects affected / exposed
    1 / 255 (0.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urosepsis
         subjects affected / exposed
    1 / 255 (0.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 255 (0.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Viral infection
         subjects affected / exposed
    1 / 255 (0.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 255 (0.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    1 / 255 (0.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Olaparib
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    246 / 255 (96.47%)
    Investigations
    Neutrophil count decreased
         subjects affected / exposed
    14 / 255 (5.49%)
         occurrences all number
    18
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    23 / 255 (9.02%)
         occurrences all number
    28
    Dysgeusia
         subjects affected / exposed
    16 / 255 (6.27%)
         occurrences all number
    18
    Headache
         subjects affected / exposed
    47 / 255 (18.43%)
         occurrences all number
    103
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    22 / 255 (8.63%)
         occurrences all number
    37
    Anaemia
         subjects affected / exposed
    98 / 255 (38.43%)
         occurrences all number
    168
    Neutropenia
         subjects affected / exposed
    40 / 255 (15.69%)
         occurrences all number
    65
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    70 / 255 (27.45%)
         occurrences all number
    94
    Fatigue
         subjects affected / exposed
    59 / 255 (23.14%)
         occurrences all number
    84
    Pyrexia
         subjects affected / exposed
    31 / 255 (12.16%)
         occurrences all number
    43
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    21 / 255 (8.24%)
         occurrences all number
    25
    Constipation
         subjects affected / exposed
    30 / 255 (11.76%)
         occurrences all number
    37
    Abdominal pain upper
         subjects affected / exposed
    19 / 255 (7.45%)
         occurrences all number
    31
    Nausea
         subjects affected / exposed
    140 / 255 (54.90%)
         occurrences all number
    236
    Vomiting
         subjects affected / exposed
    67 / 255 (26.27%)
         occurrences all number
    111
    Dyspepsia
         subjects affected / exposed
    25 / 255 (9.80%)
         occurrences all number
    30
    Diarrhoea
         subjects affected / exposed
    53 / 255 (20.78%)
         occurrences all number
    72
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    21 / 255 (8.24%)
         occurrences all number
    24
    Cough
         subjects affected / exposed
    35 / 255 (13.73%)
         occurrences all number
    40
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    15 / 255 (5.88%)
         occurrences all number
    15
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    39 / 255 (15.29%)
         occurrences all number
    55
    Back pain
         subjects affected / exposed
    28 / 255 (10.98%)
         occurrences all number
    32
    Myalgia
         subjects affected / exposed
    17 / 255 (6.67%)
         occurrences all number
    17
    Pain in extremity
         subjects affected / exposed
    21 / 255 (8.24%)
         occurrences all number
    24
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    13 / 255 (5.10%)
         occurrences all number
    14
    Urinary tract infection
         subjects affected / exposed
    16 / 255 (6.27%)
         occurrences all number
    22
    Nasopharyngitis
         subjects affected / exposed
    14 / 255 (5.49%)
         occurrences all number
    17
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    31 / 255 (12.16%)
         occurrences all number
    36

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Apr 2018
    The protocol was expanded to include a cohort of patients with somatic BRCA mutations (sBRCAm).
    22 Oct 2020
    The contraceptive language was updated based on feedback from the Czech Republic regulatory authority. Myelodysplastic syndrome (MDS)/acute myeloid leukaemia (AML) were changed from important potential risks to important identified risks due to a change in risks related to olaparib. Clarification of post study access in the form of transition to a roll-over study (ROSY-O), continuous supply within this trial, or switching to commercial drug.
    19 Apr 2021
    The second time point for statistical analysis has been extended to Q2/Q3 2021 due to longer than expected survival. Based on the current death event rate, at least~ 130 deaths ( ~52% maturity) are predicted to have occurred by this date. In order to reduce the burden on patients in terms of schedule of assessments, the follow-up after data cut-off (DCO) was reduced. Patients still receiving treatment with olaparib will have the option of continuing to receive olaparib as part of the roll over ROSY-O study (NCT04421963). Acceptable non-hormonal and hormonal birth control methods were updated following Investigator Brochure update.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Due to insufficient number of patients in sBRCA cohort, the outcome measures were not calculated.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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