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Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer (OlympiA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02032823
Recruitment Status : Active, not recruiting
First Posted : January 10, 2014
Results First Posted : December 8, 2021
Last Update Posted : March 17, 2022
Sponsor:
Collaborators:
Breast International Group
Frontier Science & Technology Research Foundation, Inc.
NRG Oncology
Myriad Genetic Laboratories, Inc.
Br.E.A.S.T. -Data Center & Operational Office Institut Jules Bordet
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Drug: Olaparib
Drug: Placebo
Enrollment 1836
Recruitment Details The first patient was enrolled on 22 April 2014. Patients were randomised from 546 centres in 23 countries worldwide.
Pre-assignment Details Patients with unknown germline BRCA (gBRCA) mutation status prior to randomisation underwent Screening Part 1 to ascertain gBRCA mutation status during, or prior to, neoadjuvant/adjuvant chemotherapy. All patients with known gBRCA mutation status (including those found through Screening Part 1) underwent Screening Part 2.
Arm/Group Title Olaparib Placebo
Hide Arm/Group Description Olaparib tablets 300mg taken orally twice daily. Placebo tablets taken orally twice daily.
Period Title: Overall Study
Started 921 915
Completed 0 0
Not Completed 921 915
Reason Not Completed
Death             59             86
Lost to Follow-up             12             15
Withdrawal by Subject             65             49
Ongoing study at data cut-off             782             760
Other (e.g investigators decision, protocol deviation, randomised by mistake)             3             5
Arm/Group Title Olaparib Placebo Total
Hide Arm/Group Description Olaparib tablets 300mg taken orally twice daily. Placebo tablets taken orally twice daily. Total of all reporting groups
Overall Number of Baseline Participants 921 915 1836
Hide Baseline Analysis Population Description
Full Analysis Set (FAS)
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 921 participants 915 participants 1836 participants
43.0  (9.8) 43.6  (10.1) 43.3  (10.0)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 921 participants 915 participants 1836 participants
<30 years 51 59 110
30-39 years 333 306 639
40-49 years 315 308 623
50-59 years 166 172 338
60-69 years 48 66 114
>=70 years 8 4 12
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 921 participants 915 participants 1836 participants
Female
919
  99.8%
911
  99.6%
1830
  99.7%
Male
2
   0.2%
4
   0.4%
6
   0.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 921 participants 915 participants 1836 participants
HISPANIC OR LATINO 34 24 58
NOT HISPANIC OR LATINO 805 812 1617
NOT KNOWN, NOT RECORDED, OR REFUSED 82 79 161
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 921 participants 915 participants 1836 participants
AMERICAN INDIAN OR ALASKA NATIVE 3 1 4
ASIAN 259 272 531
BLACK OR AFRICAN AMERICAN 19 29 48
NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER 1 0 1
WHITE 626 599 1225
OTHER 3 6 9
MISSING 10 8 18
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 921 participants 915 participants 1836 participants
Argentina 16 12 28
Australia 30 30 60
Austria 28 25 53
Belgium 12 26 38
Canada 11 23 34
China 117 130 247
France 77 65 142
Germany 106 92 198
United Kingdom 60 46 106
Hungary 8 9 17
Iceland 5 1 6
Israel 30 35 65
Italy 30 27 57
Japan 64 76 140
Netherlands 11 18 29
Poland 50 59 109
Portugal 7 6 13
Korea, Republic Of 53 44 97
Spain 63 46 109
Sweden 20 15 35
Switzerland 4 17 21
Taiwan, Province Of China 8 4 12
United States 111 109 220
1.Primary Outcome
Title Invasive Disease Free Survival (IDFS)
Hide Description An IDFS event is defined as the first occurrence of loco-regional or distant recurrence or new cancer or death from any cause.
Time Frame From date of randomisation to data cut off: 27 March 2020 (approximately 5 years 11 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS)
Arm/Group Title Olaparib Placebo
Hide Arm/Group Description:
Olaparib tablets 300mg taken orally twice daily.
Placebo tablets taken orally twice daily.
Overall Number of Participants Analyzed 921 915
Measure Type: Count of Participants
Unit of Measure: Participants
106
  11.5%
178
  19.5%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olaparib, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0000073
Comments A multiple testing procedure is employed across the primary and all key secondary endpoints to strongly control overall type I error at 5% (2 sided) accounting for all analysis timepoints.
Method Log Rank
Comments Log rank test is stratified by chemotherapy type, hormone receptor status, and prior platinum therapy using a pre-specified pooling strategy.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.581
Confidence Interval (2-Sided) 99.5%
0.409 to 0.816
Estimation Comments Estimate of the treatment hazard ratio is based on a stratified Cox's Proportional Hazards Model, <1 indicates a lower risk with olaparib compared with placebo arm. Stratification factors are the same as those used in the stratified log-rank test.
2.Secondary Outcome
Title Distant Disease Free Survival (DDFS)
Hide Description A DDFS event is defined as documented evidence of first distant recurrence of breast cancer or death from any cause
Time Frame From date of randomisation to data cut off: 27 March 2020 (approximately 5 years 11 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS)
Arm/Group Title Olaparib Placebo
Hide Arm/Group Description:
Olaparib tablets 300mg taken orally twice daily.
Placebo tablets taken orally twice daily.
Overall Number of Participants Analyzed 921 915
Measure Type: Count of Participants
Unit of Measure: Participants
89
   9.7%
152
  16.6%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olaparib, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0000257
Comments A multiple testing procedure is employed across the primary and all key secondary endpoints to strongly control overall type I error at 5% (2 sided) accounting for all analysis timepoints.
Method Log Rank
Comments Log rank test is stratified by chemotherapy type, hormone receptor status, and prior platinum therapy using a pre-specified pooling strategy.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.574
Confidence Interval (2-Sided) 99.5%
0.392 to 0.831
Estimation Comments Estimate of the treatment hazard ratio is based on a stratified Cox's Proportional Hazards Model, <1 indicates a lower risk with olaparib compared with placebo arm. Stratification factors are the same as those used in the stratified log-rank test.
3.Secondary Outcome
Title Overall Survival (OS)
Hide Description An OS event is defined as death by any cause.
Time Frame From date of randomisation to data cut off: 27 March 2020 (approximately 5 years 11 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS)
Arm/Group Title Olaparib Placebo
Hide Arm/Group Description:
Olaparib tablets 300mg taken orally twice daily.
Placebo tablets taken orally twice daily.
Overall Number of Participants Analyzed 921 915
Measure Type: Count of Participants
Unit of Measure: Participants
59
   6.4%
86
   9.4%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olaparib, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0236
Comments A multiple testing procedure is employed across the primary and all key secondary endpoints to strongly control overall type I error at 5% (2 sided) accounting for all analysis timepoints.
Method Log Rank
Comments Log rank test is stratified by chemotherapy type, hormone receptor status, and prior platinum therapy using a pre-specified pooling strategy.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.683
Confidence Interval (2-Sided) 99%
0.438 to 1.053
Estimation Comments Estimate of the treatment hazard ratio is based on a stratified Cox's Proportional Hazards Model, <1 indicates a lower risk with olaparib compared with placebo arm. Stratification factors are the same as those used in the stratified log-rank test.
4.Secondary Outcome
Title Number of Participants With Contralateral Breast Cancers, New Primary Ovarian Cancer, New Primary Fallopian Tube Cancer and New Primary Peritoneal Cancer
Hide Description Number of patients with contralateral invasive breast cancer, contralateral non-invasive breast cancer, new primary ovarian cancer, new primary fallopian tube cancer and new primary peritoneal cancer. Analysis of contralateral breast cancers exclude patients with a bilateral mastectomy prior to randomisation. Analysis of new primary ovarian cancers excludes male patients and patients with a bilateral oophorectomy prior to randomisation. Analysis of new primary fallopian tube cancer excludes male patients and patients with a bilateral salpingectomy prior to randomisation. Analysis of new primary peritoneal cancers excludes male patients.
Time Frame From date of randomisation to data cut off: 27 March 2020 (approximately 5 years 11 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS)
Arm/Group Title Olaparib Placebo
Hide Arm/Group Description:
Olaparib tablets 300mg taken orally twice daily.
Placebo tablets taken orally twice daily.
Overall Number of Participants Analyzed 921 915
Measure Type: Count of Participants
Unit of Measure: Participants
Contralateral invasive breast cancer Number Analyzed 589 participants 598 participants
11
   1.9%
14
   2.3%
Contralateral non-invasive breast cancer Number Analyzed 589 participants 598 participants
2
   0.3%
3
   0.5%
New primary ovarian cancer Number Analyzed 735 participants 747 participants
1
   0.1%
4
   0.5%
New primary fallopian tube cancer Number Analyzed 756 participants 758 participants
1
   0.1%
4
   0.5%
New primary peritoneal cancer Number Analyzed 919 participants 911 participants
0
   0.0%
0
   0.0%
5.Secondary Outcome
Title Change From Baseline for FACIT-Fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue) Score for Participants Who Completed Neoadjuvant Chemotherapy
Hide Description Change from baseline for FACIT-Fatigue Score at 6 and 12 months for patients who completed neoadjuvant chemotherapy. Adjusted least-square mean changes and 95% Confidence Interval (CI) are obtained from mixed model for repeated measures (MMRM) analysis of the change from baseline. Only patients with evaluable baseline forms are included. FACIT-Fatigue score ranges from 0 to 52 with higher score indicating less fatigue.
Time Frame 6 and 12 months after randomisation
Hide Outcome Measure Data
Hide Analysis Population Description
Patient reported outcomes (PRO) Analysis Set
Arm/Group Title Olaparib Placebo
Hide Arm/Group Description:
Olaparib tablets 300mg taken orally twice daily.
Placebo tablets taken orally twice daily.
Overall Number of Participants Analyzed 371 356
Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
Change from baseline FACIT-Fatigue Score to 6 months
-1.5
(-2.2 to -0.7)
-0.2
(-1.0 to 0.6)
Change from baseline FACIT-Fatigue Score to 12 months
-1.5
(-2.4 to -0.6)
0.0
(-0.9 to 0.9)
6.Secondary Outcome
Title Change From Baseline for FACIT-Fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue) Score for Participants Who Completed Adjuvant Chemotherapy
Hide Description Change from baseline for FACIT-Fatigue Score at 6 and 12 months for patients who completed adjuvant chemotherapy. Adjusted least-square mean changes and 95% CI are obtained from mixed model for repeated measures (MMRM) analysis of the change from baseline. Only patients with evaluable baseline forms are included. FACIT-Fatigue score ranges from 0 to 52 with higher score indicating less fatigue.
Time Frame 6 and 12 months after randomisation
Hide Outcome Measure Data
Hide Analysis Population Description
Patient reported outcomes (PRO) Analysis Set
Arm/Group Title Olaparib Placebo
Hide Arm/Group Description:
Olaparib tablets 300mg taken orally twice daily.
Placebo tablets taken orally twice daily.
Overall Number of Participants Analyzed 375 403
Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
Change from baseline FACIT-Fatigue Score to 6 months
-0.7
(-1.4 to 0.1)
0.6
(-0.1 to 1.3)
Change from baseline FACIT-Fatigue Score to 12 months
-0.8
(-1.6 to 0.0)
0.5
(-0.3 to 1.2)
7.Secondary Outcome
Title Change From Baseline for EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core Questions 30) Scores for Participants Who Completed Neoadjuvant Chemotherapy
Hide Description Change from baseline for EORTC QLQ-C30 Global health status QOL (Quality of Life) Score at 6 and 12 months for patients who completed neoadjuvant chemotherapy. Adjusted least-square mean changes and 95% CI are obtained from mixed model for repeated measures (MMRM) analysis of the change from baseline. Only patients with evaluable baseline forms are included. EORTC QLQ-C30 scores range from 0 to 100 with higher score indicating better quality of life.
Time Frame 6 and 12 months after randomisation
Hide Outcome Measure Data
Hide Analysis Population Description
Patient reported outcomes (PRO) Analysis Set
Arm/Group Title Olaparib Placebo
Hide Arm/Group Description:
Olaparib tablets 300mg taken orally twice daily.
Placebo tablets taken orally twice daily.
Overall Number of Participants Analyzed 380 358
Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
Change from baseline EORTC QLQ-C30 Global health status score to 6 months
-0.2
(-2.0 to 1.6)
0.5
(-1.3 to 2.4)
Change from baseline EORTC QLQ-C30 Global health status score to 12 months
0.4
(-1.7 to 2.4)
2.8
(0.8 to 4.8)
8.Secondary Outcome
Title Change From Baseline for EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core Questions 30) Scores for Participants Who Completed Adjuvant Chemotherapy
Hide Description Change from baseline for EORTC QLQ-C30 Global health status QOL (Quality of Life) Score at 6 and 12 months for patients who completed adjuvant chemotherapy. Adjusted least-square mean changes and 95% CI are obtained from mixed model for repeated measures (MMRM) analysis of the change from baseline. Only patients with evaluable baseline forms are included. EORTC QLQ-C30 scores range from 0 to 100 with higher score indicating better quality of life.
Time Frame 6 and 12 months after randomisation
Hide Outcome Measure Data
Hide Analysis Population Description
Patient reported outcomes (PRO) Analysis Set
Arm/Group Title Olaparib Placebo
Hide Arm/Group Description:
Olaparib tablets 300mg taken orally twice daily.
Placebo tablets taken orally twice daily.
Overall Number of Participants Analyzed 383 406
Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
Change from baseline EORTC QLQ-C30 Global health status score to 6 months
-0.4
(-2.1 to 1.3)
2.3
(0.7 to 3.9)
Change from baseline EORTC QLQ-C30 Global health status score to 12 months
0.7
(-1.0 to 2.5)
3.3
(1.6 to 5.0)
Time Frame Maximum of approximately 13 months
Adverse Event Reporting Description

All-Cause Mortality was collected for the Full Analysis Set (FAS).

Serious and Other Adverse Events were collected for the Safety Analysis Set (SAS), which includes all participants who received at least 1 dose of randomized study treatment (N=1815). There were 10 patients in the olaparib arm and 11 patients in the placebo arm that did not receive study treatment and therefore are excluded from the SAS.

The Other Adverse Events section reports AE's of any grade where the frequency is above 5%.

 
Arm/Group Title Olaparib Placebo
Hide Arm/Group Description Olaparib tablets 300mg taken orally twice daily. Placebo tablets taken orally twice daily.
All-Cause Mortality
Olaparib Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   59/921 (6.41%)      86/915 (9.40%)    
Hide Serious Adverse Events
Olaparib Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   79/911 (8.67%)      76/904 (8.41%)    
Blood and lymphatic system disorders     
Anaemia  1  15/911 (1.65%)  17 1/904 (0.11%)  1
Febrile neutropenia  1  3/911 (0.33%)  3 0/904 (0.00%)  0
Cardiac disorders     
Acute myocardial infarction  1  0/911 (0.00%)  0 1/904 (0.11%)  1
Angina pectoris  1  1/911 (0.11%)  1 0/904 (0.00%)  0
Cardiac arrest  1  1/911 (0.11%)  1 0/904 (0.00%)  0
Cardiac failure  1  1/911 (0.11%)  1 0/904 (0.00%)  0
Cardiac failure congestive  1  1/911 (0.11%)  1 0/904 (0.00%)  0
Coronary artery disease  1  1/911 (0.11%)  1 0/904 (0.00%)  0
Coronary artery dissection  1  0/911 (0.00%)  0 1/904 (0.11%)  1
Myocardial infarction  1  0/911 (0.00%)  0 1/904 (0.11%)  1
Pericardial effusion  1  1/911 (0.11%)  1 0/904 (0.00%)  0
Ear and labyrinth disorders     
Deafness  1  0/911 (0.00%)  0 1/904 (0.11%)  1
Sudden hearing loss  1  1/911 (0.11%)  1 0/904 (0.00%)  0
Endocrine disorders     
Hypothyroidism  1  1/911 (0.11%)  1 0/904 (0.00%)  0
Eye disorders     
Vision blurred  1  1/911 (0.11%)  1 0/904 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain  1  0/911 (0.00%)  0 3/904 (0.33%)  3
Chronic gastritis  1  1/911 (0.11%)  1 0/904 (0.00%)  0
Colitis  1  1/911 (0.11%)  1 0/904 (0.00%)  0
Diarrhoea  1  1/911 (0.11%)  1 0/904 (0.00%)  0
Intestinal prolapse  1  0/911 (0.00%)  0 1/904 (0.11%)  1
Large intestine polyp  1  0/911 (0.00%)  0 1/904 (0.11%)  1
Melaena  1  0/911 (0.00%)  0 1/904 (0.11%)  1
Nausea  1  1/911 (0.11%)  1 0/904 (0.00%)  0
Small intestinal obstruction  1  1/911 (0.11%)  1 0/904 (0.00%)  0
Vomiting  1  2/911 (0.22%)  2 0/904 (0.00%)  0
General disorders     
Chest pain  1  1/911 (0.11%)  1 0/904 (0.00%)  0
Fatigue  1  1/911 (0.11%)  5 0/904 (0.00%)  0
Foreign body reaction  1  0/911 (0.00%)  0 1/904 (0.11%)  1
Impaired healing  1  1/911 (0.11%)  1 0/904 (0.00%)  0
Non-cardiac chest pain  1  1/911 (0.11%)  1 0/904 (0.00%)  0
Pyrexia  1  1/911 (0.11%)  1 3/904 (0.33%)  3
Hepatobiliary disorders     
Cholecystitis  1  0/911 (0.00%)  0 1/904 (0.11%)  1
Cholecystitis acute  1  0/911 (0.00%)  0 1/904 (0.11%)  1
Hepatic function abnormal  1  1/911 (0.11%)  1 0/904 (0.00%)  0
Immune system disorders     
Anaphylactic reaction  1  1/911 (0.11%)  1 0/904 (0.00%)  0
Infections and infestations     
Appendicitis  1  1/911 (0.11%)  1 0/904 (0.00%)  0
Breast cellulitis  1  0/911 (0.00%)  0 1/904 (0.11%)  1
Bronchitis  1  1/911 (0.11%)  1 0/904 (0.00%)  0
Cellulitis  1  1/911 (0.11%)  1 2/904 (0.22%)  3
Cystitis  1  0/911 (0.00%)  0 1/904 (0.11%)  1
Device related infection  1  3/911 (0.33%)  3 2/904 (0.22%)  2
Gastroenteritis  1  2/911 (0.22%)  2 0/904 (0.00%)  0
Gingivitis  1  1/911 (0.11%)  1 0/904 (0.00%)  0
Influenza  1  0/911 (0.00%)  0 1/904 (0.11%)  1
Lower respiratory tract infection  1  0/911 (0.00%)  0 1/904 (0.11%)  1
Lymphangitis  1  0/911 (0.00%)  0 1/904 (0.11%)  1
Mastitis  1  3/911 (0.33%)  3 6/904 (0.66%)  6
Pneumonia  1  1/911 (0.11%)  1 1/904 (0.11%)  1
Urinary tract infection  1  1/911 (0.11%)  1 0/904 (0.00%)  0
Wound infection  1  2/911 (0.22%)  2 1/904 (0.11%)  1
Injury, poisoning and procedural complications     
Craniocerebral injury  1  0/911 (0.00%)  0 1/904 (0.11%)  1
Gastrointestinal procedural complication  1  0/911 (0.00%)  0 1/904 (0.11%)  1
Post procedural haematoma  1  1/911 (0.11%)  1 0/904 (0.00%)  0
Post procedural haemorrhage  1  0/911 (0.00%)  0 1/904 (0.11%)  1
Radiation pneumonitis  1  1/911 (0.11%)  1 0/904 (0.00%)  0
Ureteric injury  1  1/911 (0.11%)  1 0/904 (0.00%)  0
Vascular access complication  1  0/911 (0.00%)  0 1/904 (0.11%)  1
Wound complication  1  0/911 (0.00%)  0 1/904 (0.11%)  1
Wound dehiscence  1  1/911 (0.11%)  1 4/904 (0.44%)  4
Investigations     
Blood bilirubin increased  1  0/911 (0.00%)  0 1/904 (0.11%)  3
Neutrophil count decreased  1  1/911 (0.11%)  1 0/904 (0.00%)  0
Platelet count decreased  1  0/911 (0.00%)  0 1/904 (0.11%)  1
Metabolism and nutrition disorders     
Dehydration  1  1/911 (0.11%)  1 0/904 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Back pain  1  2/911 (0.22%)  2 1/904 (0.11%)  1
Bone pain  1  0/911 (0.00%)  0 1/904 (0.11%)  1
Chest wall mass  1  0/911 (0.00%)  0 1/904 (0.11%)  1
Intervertebral disc protrusion  1  0/911 (0.00%)  0 1/904 (0.11%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acute myeloid leukaemia  1  1/911 (0.11%)  1 1/904 (0.11%)  1
Benign breast neoplasm  1  0/911 (0.00%)  0 1/904 (0.11%)  1
Breast cancer  1  1/911 (0.11%)  1 3/904 (0.33%)  3
Breast cancer female  1  0/911 (0.00%)  0 2/904 (0.22%)  2
Chest wall tumour  1  0/911 (0.00%)  0 1/904 (0.11%)  1
Endometrial adenocarcinoma  1  1/911 (0.11%)  1 0/904 (0.00%)  0
Fallopian tube cancer  1  0/911 (0.00%)  0 1/904 (0.11%)  1
Fibroadenoma of breast  1  0/911 (0.00%)  0 1/904 (0.11%)  1
Invasive lobular breast carcinoma  1  1/911 (0.11%)  1 0/904 (0.00%)  0
Malignant melanoma  1  1/911 (0.11%)  1 4/904 (0.44%)  4
Ovarian cancer  1  0/911 (0.00%)  0 4/904 (0.44%)  4
Ovarian germ cell teratoma  1  0/911 (0.00%)  0 1/904 (0.11%)  1
Nervous system disorders     
Ataxia  1  1/911 (0.11%)  1 0/904 (0.00%)  0
Cognitive disorder  1  1/911 (0.11%)  1 0/904 (0.00%)  0
Dizziness  1  0/911 (0.00%)  0 1/904 (0.11%)  1
Headache  1  2/911 (0.22%)  2 1/904 (0.11%)  1
Lacunar infarction  1  0/911 (0.00%)  0 1/904 (0.11%)  1
Migraine with aura  1  0/911 (0.00%)  0 1/904 (0.11%)  1
Sciatica  1  0/911 (0.00%)  0 1/904 (0.11%)  1
Syncope  1  1/911 (0.11%)  1 1/904 (0.11%)  1
Vith nerve disorder  1  1/911 (0.11%)  1 0/904 (0.00%)  0
Pregnancy, puerperium and perinatal conditions     
Abortion spontaneous  1  0/911 (0.00%)  0 1/904 (0.11%)  1
Product Issues     
Device dislocation  1  1/911 (0.11%)  1 0/904 (0.00%)  0
Psychiatric disorders     
Bipolar disorder  1  1/911 (0.11%)  1 0/904 (0.00%)  0
Depression  1  0/911 (0.00%)  0 2/904 (0.22%)  2
Suicidal ideation  1  0/911 (0.00%)  0 1/904 (0.11%)  1
Suicide attempt  1  1/911 (0.11%)  1 0/904 (0.00%)  0
Renal and urinary disorders     
Acute kidney injury  1  1/911 (0.11%)  1 0/904 (0.00%)  0
Bladder disorder  1  0/911 (0.00%)  0 1/904 (0.11%)  1
Nephrolithiasis  1  1/911 (0.11%)  1 0/904 (0.00%)  0
Reproductive system and breast disorders     
Breast disorder  1  1/911 (0.11%)  1 0/904 (0.00%)  0
Breast fibrosis  1  0/911 (0.00%)  0 1/904 (0.11%)  1
Breast mass  1  0/911 (0.00%)  0 1/904 (0.11%)  1
Breast pain  1  0/911 (0.00%)  0 1/904 (0.11%)  1
Dysfunctional uterine bleeding  1  1/911 (0.11%)  1 0/904 (0.00%)  0
Endometrial hyperplasia  1  1/911 (0.11%)  1 0/904 (0.00%)  0
Metrorrhagia  1  1/911 (0.11%)  1 0/904 (0.00%)  0
Ovarian cyst  1  1/911 (0.11%)  1 0/904 (0.00%)  0
Ovarian haemorrhage  1  1/911 (0.11%)  1 0/904 (0.00%)  0
Uterine polyp  1  1/911 (0.11%)  1 1/904 (0.11%)  1
Vaginal haemorrhage  1  1/911 (0.11%)  1 0/904 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Cough  1  0/911 (0.00%)  0 1/904 (0.11%)  1
Dyspnoea  1  2/911 (0.22%)  2 0/904 (0.00%)  0
Lung disorder  1  1/911 (0.11%)  1 0/904 (0.00%)  0
Pneumonitis  1  2/911 (0.22%)  2 1/904 (0.11%)  1
Pneumothorax  1  0/911 (0.00%)  0 1/904 (0.11%)  1
Surgical and medical procedures     
Oophorectomy  1  0/911 (0.00%)  0 1/904 (0.11%)  1
Vascular disorders     
Embolism  1  2/911 (0.22%)  2 0/904 (0.00%)  0
Lymphoedema  1  1/911 (0.11%)  1 0/904 (0.00%)  0
1
Term from vocabulary, MedDRA v22.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Olaparib Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   791/911 (86.83%)      668/904 (73.89%)    
Blood and lymphatic system disorders     
Anaemia  1  200/911 (21.95%)  261 34/904 (3.76%)  39
Gastrointestinal disorders     
Abdominal pain  1  86/911 (9.44%)  96 65/904 (7.19%)  77
Constipation  1  84/911 (9.22%)  89 77/904 (8.52%)  87
Diarrhoea  1  160/911 (17.56%)  198 124/904 (13.72%)  162
Dyspepsia  1  55/911 (6.04%)  62 37/904 (4.09%)  39
Nausea  1  518/911 (56.86%)  680 211/904 (23.34%)  265
Stomatitis  1  81/911 (8.89%)  116 36/904 (3.98%)  38
Vomiting  1  204/911 (22.39%)  293 74/904 (8.19%)  84
General disorders     
Fatigue  1  365/911 (40.07%)  439 247/904 (27.32%)  287
Influenza like illness  1  57/911 (6.26%)  64 43/904 (4.76%)  55
Pain  1  68/911 (7.46%)  78 74/904 (8.19%)  83
Pyrexia  1  48/911 (5.27%)  57 39/904 (4.31%)  44
Infections and infestations     
Nasopharyngitis  1  31/911 (3.40%)  45 52/904 (5.75%)  74
Upper respiratory tract infection  1  79/911 (8.67%)  91 75/904 (8.30%)  104
Investigations     
Lymphocyte count decreased  1  61/911 (6.70%)  87 15/904 (1.66%)  16
Neutrophil count decreased  1  145/911 (15.92%)  210 59/904 (6.53%)  80
White blood cell count decreased  1  143/911 (15.70%)  210 52/904 (5.75%)  69
Metabolism and nutrition disorders     
Decreased appetite  1  119/911 (13.06%)  135 53/904 (5.86%)  55
Musculoskeletal and connective tissue disorders     
Arthralgia  1  84/911 (9.22%)  89 108/904 (11.95%)  119
Back pain  1  60/911 (6.59%)  65 73/904 (8.08%)  77
Myalgia  1  50/911 (5.49%)  58 49/904 (5.42%)  50
Pain in extremity  1  63/911 (6.92%)  75 62/904 (6.86%)  68
Nervous system disorders     
Dizziness  1  104/911 (11.42%)  112 67/904 (7.41%)  73
Dysgeusia  1  107/911 (11.75%)  125 38/904 (4.20%)  41
Headache  1  178/911 (19.54%)  217 151/904 (16.70%)  195
Psychiatric disorders     
Insomnia  1  67/911 (7.35%)  71 61/904 (6.75%)  65
Respiratory, thoracic and mediastinal disorders     
Cough  1  77/911 (8.45%)  84 72/904 (7.96%)  80
Vascular disorders     
Hot flush  1  72/911 (7.90%)  75 75/904 (8.30%)  77
1
Term from vocabulary, MedDRA v22.1
Indicates events were collected by systematic assessment
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.
Restrictions are imposed by the trial's Steering Committee (SC) and intend to ensure that all publications/presentations are peer reviewed by the SC. Sponsor has the right to review/comment on the content of the material to be published/presented, may request removal of confidential information (e.g. patentable information/trade secrets) within max 90 days. Individual Institutions may publish/present data from their site(s) in compliance with conditions defined in Study Publication Policy.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Global Clinical Lead
Organization: AstraZeneca
Phone: 1-877-240-9479
EMail: information.center@astrazeneca.com
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02032823    
Other Study ID Numbers: D081CC00006
NSABP B-55 ( Other Identifier: NSABP )
BIG 6-13 ( Other Identifier: Breast International Group )
First Submitted: January 3, 2014
First Posted: January 10, 2014
Results First Submitted: September 24, 2021
Results First Posted: December 8, 2021
Last Update Posted: March 17, 2022