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

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ClinicalTrials.gov Identifier: NCT02032823

Recruitment Status : Active, not recruiting

First Posted : January 10, 2014

Results First Posted : December 8, 2021

Last Update Posted : May 13, 2024

View this study on the modernized ClinicalTrials.gov

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

Participant Flow

Recruitment Details	The first patient was enrolled on 22 April 2014. Patients were randomised from 554 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
Arm/Group Description	Olaparib tablets 300mg taken orally...	Placebo tablets taken orally twice ...
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	75	109
Lost to Follow-up	18	17
Withdrawal by Subject	70	53
Ongoing study at data cut-off	755	731
Other (e.g investigators decision, protocol deviation, randomised by mistake)	3	5

Baseline Characteristics

Arm/Group Title		Olaparib	Placebo	Total
Arm/Group Description		Olaparib tablets 300mg taken orally...	Placebo tablets taken orally twice ...	Total of all reporting groups
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
Baseline Analysis Population Description		...
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

Outcome Measures

1.Primary Outcome


Title	Invasive Disease Free Survival (IDFS)
Description	An IDFS event is defined as the first occurrence of loco-regional or d...
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)

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS)


Arm/Group Title	Olaparib	Placebo
Arm/Group Description:	Olaparib tablets 300mg taken orally...	Placebo tablets taken orally twice ...
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%

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)
Description	A DDFS event is defined as documented evidence of first distant recurr...
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)

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS)


Arm/Group Title	Olaparib	Placebo
Arm/Group Description:	Olaparib tablets 300mg taken orally...	Placebo tablets taken orally twice ...
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%

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)
Description	An OS event is defined as death by any cause.
Description	An OS event is defined as death by any cause.
Time Frame	From date of randomisation to data cut off: 12 July 2021 (approximately 7 years 3 months)

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS)


Arm/Group Title	Olaparib	Placebo
Arm/Group Description:	Olaparib tablets 300mg taken orally...	Placebo tablets taken orally twice ...
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
	75 8.1%	109 11.9%

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	0.0091
	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	0.678
	Confidence Interval	(2-Sided) 98.5% 0.468 to 0.973
	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 Invasive and Non-invasive Breast Cancer, New Primary Ovarian Cancer, New Primary Fallopian Tube Cancer and New Primary Peritoneal Cancer
Description	Number of patients with contralateral invasive breast cancer, contrala...
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: 12 July 2021 (approximately 7 years 3 months)

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS)


Arm/Group Title		Olaparib	Placebo
Arm/Group Description:		Olaparib tablets 300mg taken orally...	Placebo tablets taken orally twice ...
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	583 participants	597 participants
Contralateral invasive breast cancer		19 3.3%	21 3.5%
Contralateral non-invasive breast cancer	Number Analyzed	583 participants	597 participants
Contralateral non-invasive breast cancer		2 0.3%	4 0.7%
New primary ovarian cancer	Number Analyzed	735 participants	747 participants
New primary ovarian cancer		1 0.1%	5 0.7%
New primary fallopian tube cancer	Number Analyzed	756 participants	758 participants
New primary fallopian tube cancer		1 0.1%	4 0.5%
New primary peritoneal cancer	Number Analyzed	919 participants	911 participants
New primary peritoneal cancer		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
Description	Change from baseline for FACIT-Fatigue Score at 6, 12, 18 and 24 month...
Description	Change from baseline for FACIT-Fatigue Score at 6, 12, 18 and 24 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, 12, 18 and 24 months after randomisation (data cut off: 12 July 2021)

Outcome Measure Data

Analysis Population Description

Patient reported outcomes (PRO) Analysis Set


Arm/Group Title		Olaparib	Placebo
Arm/Group Description:		Olaparib tablets 300mg taken orally...	Placebo tablets taken orally twice ...
Arm/Group Description:		Olaparib tablets 300mg taken orally twice daily.	Placebo tablets taken orally twice daily.
Overall Number of Participants Analyzed		382	359
Mean (95% Confidence Interval) Unit of Measure: Scores on a scale
Change from baseline FACIT-Fatigue Score to 6 months	Number Analyzed	382 participants	359 participants
Change from baseline FACIT-Fatigue Score to 6 months		-1.5 (-2.3 to -0.8)	-0.2 (-1.0 to 0.6)
Change from baseline FACIT-Fatigue Score to 12 months	Number Analyzed	382 participants	356 participants
Change from baseline FACIT-Fatigue Score to 12 months		-1.5 (-2.4 to -0.6)	0.0 (-0.9 to 0.9)
Change from baseline FACIT-Fatigue Score to 18 months	Number Analyzed	382 participants	359 participants
Change from baseline FACIT-Fatigue Score to 18 months		1.3 (0.4 to 2.2)	1.4 (0.5 to 2.3)
Change from baseline FACIT-Fatigue Score to 24 months	Number Analyzed	382 participants	359 participants
Change from baseline FACIT-Fatigue Score to 24 months		1.6 (0.7 to 2.4)	2.0 (1.1 to 2.9)

6.Secondary Outcome


Title	Change From Baseline for FACIT-Fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue) Score for Participants Who Completed Adjuvant Chemotherapy
Description	Change from baseline for FACIT-Fatigue Score at 6, 12, 18 and 24 month...
Description	Change from baseline for FACIT-Fatigue Score at 6, 12, 18 and 24 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, 12, 18 and 24 months after randomisation (data cut off: 12 July 2021)

Outcome Measure Data

Analysis Population Description

Patient reported outcomes (PRO) Analysis Set


Arm/Group Title	Olaparib	Placebo
Arm/Group Description:	Olaparib tablets 300mg taken orally...	Placebo tablets taken orally twice ...
Arm/Group Description:	Olaparib tablets 300mg taken orally twice daily.	Placebo tablets taken orally twice daily.
Overall Number of Participants Analyzed	382	406
Mean (95% Confidence Interval) Unit of Measure: Scores on a scale
Change from baseline FACIT-Fatigue Score to 6 months	-0.7 (-1.5 to 0.0)	0.6 (-0.2 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)
Change from baseline FACIT-Fatigue Score to 18 months	0.9 (0.1 to 1.7)	1.2 (0.4 to 2.0)
Change from baseline FACIT-Fatigue Score to 24 months	1.3 (0.5 to 2.1)	1.6 (0.7 to 2.4)

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
Description	Change from baseline for EORTC QLQ-C30 Global health status QOL (Quali...
Description	Change from baseline for EORTC QLQ-C30 Global health status QOL (Quality of Life) Score at 6, 12, 18 and 24 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, 12, 18 and 24 months after randomisation (data cut off: 12 July 2021)

Outcome Measure Data

Analysis Population Description

Patient reported outcomes (PRO) Analysis Set


Arm/Group Title	Olaparib	Placebo
Arm/Group Description:	Olaparib tablets 300mg taken orally...	Placebo tablets taken orally twice ...
Arm/Group Description:	Olaparib tablets 300mg taken orally twice daily.	Placebo tablets taken orally twice daily.
Overall Number of Participants Analyzed	382	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	-0.4 (-2.2 to 1.4)	0.4 (-1.4 to 2.2)
Change from baseline EORTC QLQ-C30 Global health status score to 12 months	0.5 (-1.5 to 2.4)	2.7 (0.7 to 4.7)
Change from baseline EORTC QLQ-C30 Global health status score to 18 months	3.3 (1.3 to 5.3)	4.4 (2.3 to 6.4)
Change from baseline EORTC QLQ-C30 Global health status score to 24 months	2.8 (0.6 to 5.0)	6.1 (3.8 to 8.4)

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
Description	Change from baseline for EORTC QLQ-C30 Global health status QOL (Quali...
Description	Change from baseline for EORTC QLQ-C30 Global health status QOL (Quality of Life) Score at 6, 12, 18 and 24 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, 12, 18 and 24 months after randomisation (data cut off: 12 July 2021)

Outcome Measure Data

Analysis Population Description

Patient reported outcomes (PRO) Analysis Set


Arm/Group Title	Olaparib	Placebo
Arm/Group Description:	Olaparib tablets 300mg taken orally...	Placebo tablets taken orally twice ...
Arm/Group Description:	Olaparib tablets 300mg taken orally twice daily.	Placebo tablets taken orally twice daily.
Overall Number of Participants Analyzed	383	407
Mean (95% Confidence Interval) Unit of Measure: Scores on a scale
Change from baseline EORTC QLQ-C30 Global health status score to 6 months	-0.5 (-2.2 to 1.2)	2.2 (0.6 to 3.8)
Change from baseline EORTC QLQ-C30 Global health status score to 12 months	0.6 (-1.1 to 2.4)	3.1 (1.5 to 4.8)
Change from baseline EORTC QLQ-C30 Global health status score to 18 months	2.9 (1.1 to 4.7)	5.1 (3.3 to 6.9)
Change from baseline EORTC QLQ-C30 Global health status score to 24 months	4.5 (2.6 to 6.4)	4.8 (2.9 to 6.7)

Adverse Events

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
Arm/Group Description	Description (Arm-group)		Description (Arm-group)
Arm/Group Description	Description (Arm-group)		Description (Arm-group)
All-Cause Mortality
	Olaparib		Placebo
	Affected / at Risk (%)		Affected / at Risk (%)
Total	75/921 (8.14%)		109/915 (11.91%)
Serious Adverse Events Serious Adverse Events
	Olaparib		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	79/911 (8.67%)		78/904 (8.63%)
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
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
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
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%)	2
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	2/904 (0.22%)	2
Fallopian tube cancer stage i ^† 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 benign ^† 1	0/911 (0.00%)	0	1/904 (0.11%)	1
Nervous system disorders
Lacunar infarction ^† 1	0/911 (0.00%)	0	1/904 (0.11%)	1
Ophthalmic migraine ^† 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
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
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
Abnormal uterine bleeding ^† 1	1/911 (0.11%)	1	0/904 (0.00%)	0
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
Endometrial hyperplasia ^† 1	1/911 (0.11%)	1	0/904 (0.00%)	0
Intermenstrual bleeding ^† 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 v24.0 † Indicates events were collected by systematic assessment
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	793/911 (87.05%)		672/904 (74.34%)
Blood and lymphatic system disorders
Anaemia ^† 1	201/911 (22.06%)	262	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	78/904 (8.63%)	88
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	519/911 (56.97%)	683	213/904 (23.56%)	267
Stomatitis ^† 1	81/911 (8.89%)	116	36/904 (3.98%)	38
Vomiting ^† 1	204/911 (22.39%)	294	74/904 (8.19%)	84
General disorders
Fatigue ^† 1	366/911 (40.18%)	442	248/904 (27.43%)	288
Influenza like illness ^† 1	58/911 (6.37%)	65	44/904 (4.87%)	56
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%)	92	75/904 (8.30%)	104
Investigations
Lymphocyte count decreased ^† 1	62/911 (6.81%)	88	15/904 (1.66%)	16
Neutrophil count decreased ^† 1	146/911 (16.03%)	211	59/904 (6.53%)	80
White blood cell count decreased ^† 1	144/911 (15.81%)	213	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	89/911 (9.77%)	95	115/904 (12.72%)	127
Back pain ^† 1	60/911 (6.59%)	65	72/904 (7.96%)	76
Myalgia ^† 1	50/911 (5.49%)	58	49/904 (5.42%)	50
Pain in extremity ^† 1	62/911 (6.81%)	74	64/904 (7.08%)	70
Nervous system disorders
Dizziness ^† 1	104/911 (11.42%)	113	66/904 (7.30%)	72
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%)	85	72/904 (7.96%)	80
Vascular disorders
Hot flush ^† 1	73/911 (8.01%)	76	74/904 (8.19%)	76
1 Term from vocabulary, MedDRA v24.0 † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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

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

Perachino M, Poggio F, Arecco L, Blondeaux E, Spinaci S, Marrocco C, Levaggi A, Lambertini M. Update on Pregnancy Following Breast Cancer Diagnosis and Treatment. Cancer J. 2022 May-Jun 01;28(3):176-182. doi: 10.1097/PPO.0000000000000599.

Tutt ANJ, Garber JE, Kaufman B, Viale G, Fumagalli D, Rastogi P, Gelber RD, de Azambuja E, Fielding A, Balmana J, Domchek SM, Gelmon KA, Hollingsworth SJ, Korde LA, Linderholm B, Bandos H, Senkus E, Suga JM, Shao Z, Pippas AW, Nowecki Z, Huzarski T, Ganz PA, Lucas PC, Baker N, Loibl S, McConnell R, Piccart M, Schmutzler R, Steger GG, Costantino JP, Arahmani A, Wolmark N, McFadden E, Karantza V, Lakhani SR, Yothers G, Campbell C, Geyer CE Jr; OlympiA Clinical Trial Steering Committee and Investigators. Adjuvant Olaparib for Patients with BRCA1- or BRCA2-Mutated Breast Cancer. N Engl J Med. 2021 Jun 24;384(25):2394-2405. doi: 10.1056/NEJMoa2105215. Epub 2021 Jun 3.

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 ) 2013-003839-30 ( EudraCT Number )
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:	May 13, 2024

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