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    Clinical Trial Results:
    A Phase II, Multicentre, Open-Label Study to Assess the Efficacy and Safety of Olaparib Monotherapy and Olaparib Plus Durvalumab Combination as Neoadjuvant Therapy in Patients with BRCA Mutations and Early Stage HER2-Negative Breast Cancer (OlympiaN)

    Summary
    EudraCT number
    		 2021-005231-22
    Trial protocol
    		 ES   DE   AT   IT  
    Global end of trial date
    16 Sep 2025

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Sep 2026
    First version publication date
    27 Sep 2026
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    D931CC00001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 EudraCT Number: 2021-005231-22, EU CT Number: 2023-503529-20
    Sponsors
    Sponsor organisation name
    AstraZeneca AB
    Sponsor organisation address
    151 85, Södertälje, Sweden,
    Public contact
    Global Clinical Lead, AstraZeneca, +1 877-240-9479, information.center@astrazeneca.com
    Scientific contact
    Global Clinical Lead, AstraZeneca, +1 877-240-9479, 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
    16 Sep 2025
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Sep 2025
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    This study was to determine the efficacy and safety of neoadjuvant olaparib monotherapy and olaparib plus durvalumab combination therapy in participants with primary, operable, oestrogen receptor (ER)-negative or ER-low, human epidermal growth factor receptor 2 (HER2)-negative breast cancer with documented breast cancer susceptibility gene mutation (BRCAm) who are candidates for neoadjuvant therapy.
    Protection of trial subjects
    Based upon the available clinical efficacy and safety data for olaparib monotherapy and olaparib and durvalumab combination, and the mitigations designed for this study through participant selection and close clinical monitoring during treatment, the investigation of the potential therapeutic efficacy of neoadjuvant olaparib and of the combination of olaparib plus durvalumab in participants with BRCAm ER-negative or ER-low, HER2-negative breast cancer is acceptable, and the overall benefit/risk assessment supports the proposed study design.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Nov 2022
    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
    Spain: 22
    Country: Number of subjects enrolled
    Germany: 10
    Country: Number of subjects enrolled
    United States: 4
    Country: Number of subjects enrolled
    Australia: 3
    Country: Number of subjects enrolled
    Belgium: 3
    Country: Number of subjects enrolled
    Italy: 3
    Country: Number of subjects enrolled
    Austria: 2
    Country: Number of subjects enrolled
    Israel: 2
    Country: Number of subjects enrolled
    United Kingdom: 1
    Worldwide total number of subjects
    50
    EEA total number of subjects
    40
    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)
    45
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 114 participants were screened from 28 study sites across 9 countries. Of these, 50 participants were enrolled.

    Pre-assignment
    Screening details
    		 Approximately 50 participants were planned to be enrolled in 2 cohorts, Cohort A (lower risk) and Cohort B (higher risk), with approximately 25 participants each.

    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
    Are arms mutually exclusive
    Yes

    Arm title
    		 AZD2281
    Arm description
    		 Cohort A: AZD2281 monotherapy 300 mg BID continuously to lower-risk participants
    Arm type
    		 Experimental

    Investigational medicinal product name
    Olaparib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    300 mg twice daily

    Arm title
    		 AZD2281+MEDI4736
    Arm description
    		 Cohort B: AZD2281 300 mg BID plus MEDI4736 1500 mg Q4W combination therapy to higher-risk participants
    Arm type
    		 Experimental

    Investigational medicinal product name
    Durvalumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1500 mg every 4 weeks or 20 mg/kg every 4 weeks in participants who weighed ≤ 30 kg

    Investigational medicinal product name
    Olaparib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    300 mg twice daily

    Number of subjects in period 1
    		AZD2281 AZD2281+MEDI4736
    Started
    25
    25
    Completed
    0
    0
    Not completed
    25
    25
         Consent withdrawn by subject
    -
    1
         Site terminated by sponsor
    2
    2
         Study terminated by sponsor
    23
    22

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    AZD2281
    Reporting group description
    		 Cohort A: AZD2281 monotherapy 300 mg BID continuously to lower-risk participants

    Reporting group title
    AZD2281+MEDI4736
    Reporting group description
    		 Cohort B: AZD2281 300 mg BID plus MEDI4736 1500 mg Q4W combination therapy to higher-risk participants

    Reporting group values
    		 AZD2281 AZD2281+MEDI4736 Total
    Number of subjects
    		 25 25 50
    Age Categorical
    Age at Screening
    Units: Participants
        < 30
    		 0 1 1
        30 - 39
    		 6 8 14
        40 - 49
    		 11 8 19
        50 - 59
    		 3 3 6
        60 - 69
    		 5 3 8
        >= 70
    		 0 2 2
    Age Continuous
    Age at Screening
    Units: Years
        arithmetic mean (standard deviation)
    		 47.8 ( 10.32 ) 47.2 ( 14.24 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 25 25 50
        Male
    		 0 0 0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 2 0 2
        Not Hispanic or Latino
    		 23 25 48
    Race (NIH/OMB)
    Units: Subjects
        Black or African American
    		 1 1 2
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 0 1 1
        White
    		 24 20 44
        Other
    		 0 3 3
        Not reported
    		 0 0 0
    Region of Enrollment
    Units: Subjects
        Spain
    		 13 9 22
        Germany
    		 5 5 10
        United States
    		 2 2 4
        Australia
    		 1 2 3
        Belgium
    		 1 2 3
        Italy
    		 1 2 3
        Austria
    		 1 1 2
        Israel
    		 1 1 2
        United Kingdom
    		 0 1 1
    Weight group
    Units: Subjects
        < 50
    		 1 0 1
        50 - 90
    		 21 24 45
        >= 90
    		 3 1 4
    Height
    Units: cm
        arithmetic mean (standard deviation)
    		 162.3 ( 6.55 ) 162.3 ( 6.67 ) -
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    		 68.29 ( 15.767 ) 69.38 ( 12.380 ) -

    End points

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    End points reporting groups
    Reporting group title
    AZD2281
    Reporting group description
    		 Cohort A: AZD2281 monotherapy 300 mg BID continuously to lower-risk participants

    Reporting group title
    AZD2281+MEDI4736
    Reporting group description
    		 Cohort B: AZD2281 300 mg BID plus MEDI4736 1500 mg Q4W combination therapy to higher-risk participants

    Primary: pCR rate of olaparib monotherapy and olaparib plus durvalumab combination therapy, assessed by central pathology review

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    End point title
    		 pCR rate of olaparib monotherapy and olaparib plus durvalumab combination therapy, assessed by central pathology review [1]
    End point description
    pCR = pathological complete response pCR was defined as ypT0/Tis ypN0 (ie, no invasive residual in breast and the axillary lymph nodes on evaluation of the complete resected breast specimen and all sampled regional lymph nodes) following completion of neoadjuvant systemic therapy. Results of this outcome measure are from DCO1 (20 November 2024). The Clopper Pearson method is for the computation of the 95% confidence interval (CI).
    End point type
    Primary
    End point timeframe
    Approx. 4 to 6 months
    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: No formal statistical testing was performed for this study.
    End point values
    		 AZD2281 AZD2281+MEDI4736
    Number of subjects analysed
    25
    25
    Units: Percentage
    arithmetic mean (confidence interval 95%)
        Responder - Achieved pCR
    68.0 (46.50 to 85.05)
    80.0 (59.30 to 93.17)
    No statistical analyses for this end point

    Secondary: pCR rate of olaparib monotherapy and olaparib plus durvalumab combination therapy, assessed by local pathology review

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    End point title
    		 pCR rate of olaparib monotherapy and olaparib plus durvalumab combination therapy, assessed by local pathology review
    End point description
    pCR was defined as ypT0/Tis ypN0 (ie, no invasive residual in breast and the axillary lymph nodes on evaluation of the complete resected breast specimen and all sampled regional lymph nodes) following completion of neoadjuvant systemic therapy. Results of this outcome measure are from DCO1 (20 November 2024). The Clopper Pearson method is for the computation of the 95% CI.
    End point type
    Secondary
    End point timeframe
    Approx. 4 to 6 months
    End point values
    		 AZD2281 AZD2281+MEDI4736
    Number of subjects analysed
    25
    25
    Units: Percentage
    arithmetic mean (confidence interval 95%)
        Responder - Achieved pCR
    68.0 (46.50 to 85.05)
    76.0 (54.87 to 90.64)
    No statistical analyses for this end point

    Secondary: RCB of olaparib monotherapy and olaparib plus durvalumab combination therapy as assessed by central pathology review

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    End point title
    		 RCB of olaparib monotherapy and olaparib plus durvalumab combination therapy as assessed by central pathology review
    End point description
    RCB = residual cancer burden RCB index value using 6 variables to categorize response in 1 of 4 classes: RCB 0 (pCR), I (minimal RCB), II (moderate RCB), and III (extensive RCB). RCB III included patients who had clinical progression before surgery, and there was no central pCR performed. Results of this outcome measure are from DCO1 (20 November 2024).
    End point type
    Secondary
    End point timeframe
    Approx. 4 to 6 months
    End point values
    		 AZD2281 AZD2281+MEDI4736
    Number of subjects analysed
    25
    25
    Units: Participants
        RCB-0
    17
    20
        RCB-I
    1
    1
        RCB-II
    6
    1
        RCB-III
    1
    2
        Missing
    0
    1
    No statistical analyses for this end point

    Secondary: RCB of olaparib monotherapy and olaparib plus durvalumab combination therapy as assessed by local pathology review

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    End point title
    		 RCB of olaparib monotherapy and olaparib plus durvalumab combination therapy as assessed by local pathology review
    End point description
    RCB index value using 6 variables to categorize response in 1 of 4 classes: RCB 0 (pCR), I (minimal RCB), II (moderate RCB), and III (extensive RCB). RCB III included patients who had clinical progression before surgery, and there was no central pCR performed. Results of this outcome measure are from DCO1 (20 November 2024).
    End point type
    Secondary
    End point timeframe
    Approx. 4 to 6 months
    End point values
    		 AZD2281 AZD2281+MEDI4736
    Number of subjects analysed
    25
    25
    Units: Participants
        RCB-0
    17
    19
        RCB-I
    2
    2
        RCB-II
    5
    0
        RCB-III
    1
    2
        Missing
    0
    2
    No statistical analyses for this end point

    Secondary: Percentage change in tumour volume at Week 12 and Week 24 from baseline

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    End point title
    		 Percentage change in tumour volume at Week 12 and Week 24 from baseline
    End point description
    Percentage change in tumour volume at Week 12 and Week 24 from baseline was measured using magnetic resonance imaging (MRI). Baseline was defined as the most recent measurement prior to the first administration of study intervention. Percent change from baseline was defined as: (Difference in value between post-baseline volume and baseline volume) divided by baseline volume and multiplied by 100. Results of this outcome measure are from DCO1 (20 November 2024).
    End point type
    Secondary
    End point timeframe
    Week 12 and Week 24
    End point values
    		 AZD2281 AZD2281+MEDI4736
    Number of subjects analysed
    25
    25
    Units: Percentage in tumour volume
    arithmetic mean (standard deviation)
        Percentage change from baseline at week 12
    -87.86 ( 17.527 )
    -84.49 ( 29.998 )
        Percentage change from baseline at week 24
    -42.32 ( 227.333 )
    -89.87 ( 34.726 )
    No statistical analyses for this end point

    Secondary: Number of Participants with EFS (event-free survival)

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    End point title
    		 Number of Participants with EFS (event-free survival)
    End point description
    EFS was defined as time from the first dose of study intervention administration to any of the following events: progression of disease that precluded surgery, local or distant recurrence after surgery, second primary malignancy (breast or other invasive cancers), or death due to any cause. Results of this outcome measure are from final DCO (16 September 2025). One of 3 subjects in AZD2281 + MEDI4736 group had a disease progression recorded in error; 2 (8.0%) participants had an EFS event of progression of disease reported in the neoadjuvant period.
    End point type
    Secondary
    End point timeframe
    Approx. 3 years
    End point values
    		 AZD2281 AZD2281+MEDI4736
    Number of subjects analysed
    25
    25
    Units: Participants
    3
    3
    No statistical analyses for this end point

    Secondary: Number of participants with AEs

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    End point title
    		 Number of participants with AEs
    End point description
    AE = adverse event; ECG = electrocardiogram Data included clinical observations, ECG parameters, haematology/clinical chemistry, vital signs assessed as the number of participants with AEs. Results of participants with AEs are from final DCO (16 September 2025).
    End point type
    Secondary
    End point timeframe
    Through study completion, approximately 34 months
    End point values
    		 AZD2281 AZD2281+MEDI4736
    Number of subjects analysed
    25
    25
    Units: Participants
    24
    24
    No statistical analyses for this end point

    Secondary: Number of participants with SAEs

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    End point title
    		 Number of participants with SAEs
    End point description
    SAE = serious adverse event Data included clinical observations, ECG parameters, haematology/clinical chemistry, vital signs assessed as the number of participants with AEs. Results of participants with SAEs are from final DCO (16 September 2025).
    End point type
    Secondary
    End point timeframe
    Through study completion, approximately 34 months
    End point values
    		 AZD2281 AZD2281+MEDI4736
    Number of subjects analysed
    25
    25
    Units: Participants
    4
    5
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs were collected from the time of informed consent form signature through study completion, approximately 34 months (final DCO: 16 September 2025).
    Adverse event reporting additional description
    Graded according to the Common Terminology Criteria for Adverse Event (CTCAE) grade and changes in CTCAE grade
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    28.0
    Reporting groups
    Reporting group title
    AZD2281+MEDI4736
    Reporting group description
    		 Cohort B: AZD2281 300 mg BID plus MEDI4736 1500 mg Q4W combination therapy to higher-risk participants

    Reporting group title
    AZD2281
    Reporting group description
    		 Cohort A: AZD2281 monotherapy 300 mg BID continuously to lower-risk participants

    Serious adverse events
    		 AZD2281+MEDI4736 AZD2281
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 25 (20.00%)
    4 / 25 (16.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Transient ischaemic attack
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pelvic mass
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 25 (0.00%)
    2 / 25 (8.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural infection
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Product issues
    Internal device exposed
         subjects affected / exposed
    1 / 25 (4.00%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 AZD2281+MEDI4736 AZD2281
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    23 / 25 (92.00%)
    23 / 25 (92.00%)
    Vascular disorders
    Hot flush
         subjects affected / exposed
    3 / 25 (12.00%)
    4 / 25 (16.00%)
         occurrences all number
    4
    4
    Hypertension
         subjects affected / exposed
    2 / 25 (8.00%)
    0 / 25 (0.00%)
         occurrences all number
    3
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    13 / 25 (52.00%)
    9 / 25 (36.00%)
         occurrences all number
    13
    10
    Asthenia
         subjects affected / exposed
    8 / 25 (32.00%)
    10 / 25 (40.00%)
         occurrences all number
    11
    14
    Pyrexia
         subjects affected / exposed
    5 / 25 (20.00%)
    2 / 25 (8.00%)
         occurrences all number
    7
    2
    Reproductive system and breast disorders
    Breast pain
         subjects affected / exposed
    3 / 25 (12.00%)
    4 / 25 (16.00%)
         occurrences all number
    4
    4
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    5 / 25 (20.00%)
    1 / 25 (4.00%)
         occurrences all number
    7
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    3 / 25 (12.00%)
    1 / 25 (4.00%)
         occurrences all number
    3
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    3 / 25 (12.00%)
    3 / 25 (12.00%)
         occurrences all number
    3
    3
    Amylase increased
         subjects affected / exposed
    2 / 25 (8.00%)
    1 / 25 (4.00%)
         occurrences all number
    2
    1
    Blood creatinine increased
         subjects affected / exposed
    2 / 25 (8.00%)
    2 / 25 (8.00%)
         occurrences all number
    2
    2
    Aspartate aminotransferase increased
         subjects affected / exposed
    2 / 25 (8.00%)
    2 / 25 (8.00%)
         occurrences all number
    2
    4
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    2 / 25 (8.00%)
    2 / 25 (8.00%)
         occurrences all number
    3
    2
    Weight increased
         subjects affected / exposed
    2 / 25 (8.00%)
    0 / 25 (0.00%)
         occurrences all number
    2
    0
    Injury, poisoning and procedural complications
    Procedural pain
         subjects affected / exposed
    2 / 25 (8.00%)
    1 / 25 (4.00%)
         occurrences all number
    2
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    3 / 25 (12.00%)
    4 / 25 (16.00%)
         occurrences all number
    4
    4
    Dysgeusia
         subjects affected / exposed
    4 / 25 (16.00%)
    8 / 25 (32.00%)
         occurrences all number
    5
    9
    Headache
         subjects affected / exposed
    8 / 25 (32.00%)
    8 / 25 (32.00%)
         occurrences all number
    9
    9
    Taste disorder
         subjects affected / exposed
    2 / 25 (8.00%)
    1 / 25 (4.00%)
         occurrences all number
    2
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    9 / 25 (36.00%)
    10 / 25 (40.00%)
         occurrences all number
    13
    16
    Neutropenia
         subjects affected / exposed
    5 / 25 (20.00%)
    3 / 25 (12.00%)
         occurrences all number
    7
    4
    Eye disorders
    Dry eye
         subjects affected / exposed
    2 / 25 (8.00%)
    0 / 25 (0.00%)
         occurrences all number
    2
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    9 / 25 (36.00%)
    10 / 25 (40.00%)
         occurrences all number
    11
    16
    Dyspepsia
         subjects affected / exposed
    0 / 25 (0.00%)
    3 / 25 (12.00%)
         occurrences all number
    0
    3
    Dry mouth
         subjects affected / exposed
    2 / 25 (8.00%)
    0 / 25 (0.00%)
         occurrences all number
    2
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    2 / 25 (8.00%)
    1 / 25 (4.00%)
         occurrences all number
    2
    2
    Nausea
         subjects affected / exposed
    19 / 25 (76.00%)
    15 / 25 (60.00%)
         occurrences all number
    33
    22
    Stomatitis
         subjects affected / exposed
    1 / 25 (4.00%)
    2 / 25 (8.00%)
         occurrences all number
    2
    4
    Vomiting
         subjects affected / exposed
    5 / 25 (20.00%)
    3 / 25 (12.00%)
         occurrences all number
    11
    4
    Abdominal pain upper
         subjects affected / exposed
    1 / 25 (4.00%)
    3 / 25 (12.00%)
         occurrences all number
    1
    4
    Abdominal pain
         subjects affected / exposed
    3 / 25 (12.00%)
    4 / 25 (16.00%)
         occurrences all number
    3
    5
    Constipation
         subjects affected / exposed
    3 / 25 (12.00%)
    1 / 25 (4.00%)
         occurrences all number
    5
    2
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    4 / 25 (16.00%)
    2 / 25 (8.00%)
         occurrences all number
    4
    2
    Rash
         subjects affected / exposed
    2 / 25 (8.00%)
    2 / 25 (8.00%)
         occurrences all number
    2
    3
    Endocrine disorders
    Hyperthyroidism
         subjects affected / exposed
    3 / 25 (12.00%)
    0 / 25 (0.00%)
         occurrences all number
    3
    0
    Hypothyroidism
         subjects affected / exposed
    7 / 25 (28.00%)
    0 / 25 (0.00%)
         occurrences all number
    7
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 25 (12.00%)
    2 / 25 (8.00%)
         occurrences all number
    3
    2
    Myalgia
         subjects affected / exposed
    0 / 25 (0.00%)
    2 / 25 (8.00%)
         occurrences all number
    0
    2
    Back pain
         subjects affected / exposed
    2 / 25 (8.00%)
    1 / 25 (4.00%)
         occurrences all number
    2
    1
    Infections and infestations
    COVID-19
         subjects affected / exposed
    1 / 25 (4.00%)
    2 / 25 (8.00%)
         occurrences all number
    1
    2
    Nasopharyngitis
         subjects affected / exposed
    3 / 25 (12.00%)
    5 / 25 (20.00%)
         occurrences all number
    3
    8
    Tonsillitis
         subjects affected / exposed
    0 / 25 (0.00%)
    3 / 25 (12.00%)
         occurrences all number
    0
    3
    Urinary tract infection
         subjects affected / exposed
    2 / 25 (8.00%)
    4 / 25 (16.00%)
         occurrences all number
    2
    4
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    2 / 25 (8.00%)
    4 / 25 (16.00%)
         occurrences all number
    2
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Mar 2022
    The amendment is made to expand the eligible participant population based on current literature supporting the use of neoadjuvant immuno-oncology therapy in participants with smaller volume, high-risk breast cancer.
    10 Jun 2022
    The primary purpose of this amendment is to modify inclusion criteria related to reproduction and fertility in alignment with olaparib safety guidelines.
    01 Jun 2023
    The primary purpose of this amendment is to modify safety monitoring for patients in Cohort B who experience anaemia or prolonged haematological toxicity in alignment with the updated olaparib Investigator’s Brochure and to incorporate recent changes for contraception requirements for patients being treated with olaparib.
    22 Mar 2024
    The primary purpose of this amendment is to clarify details regarding the schedule of assessments and study procedures that resulted from many questions from investigative sites when they attempted to conduct the study and to add missing procedures and tests into the End of Treatment Visit and the mandatory collection of tumour samples at definitive surgery.

    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.
    The study was closed earlier than originally planned in alignment with the scientific and ethical standards. All participants were off study treatment and had completed post-treatment safety follow-up on 17 July 2025.
    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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