Trial · NCT02032823
Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer
NCT02032823, Phase 3, Active not recruiting, AstraZeneca; results first posted 2021-12-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer. Trials, record NCT02032823. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02032823
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer
- NCT number
- NCT02032823
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 1,837 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Breast Cancer
- Interventions
- Olaparib, Placebo
- First posted
- 2014-01-10
- Last updated
- 2026-07-14
- Other registries' IDs
- eudract:2013-003839-30
- Results first posted
- 2021-12-08
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Invasive Disease Free Survival (IDFS) | From date of randomisation to data cut off: 27 March 2020 (approximately 5 years 11 months) | An IDFS event is defined as the first occurrence of loco-regional or distant recurrence or new cancer or death from any cause. |
| Secondary | Distant Disease Free Survival (DDFS) | From date of randomisation to data cut off: 27 March 2020 (approximately 5 years 11 months) | A DDFS event is defined as documented evidence of first distant recurrence of breast cancer or death from any cause |
| Secondary | Overall Survival (OS) | From date of randomisation to data cut off: 12 July 2021 (approximately 7 years 3 months) | An OS event is defined as death by any cause. |
| Secondary | 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 | From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months) | 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. |
| Secondary | Change From Baseline for FACIT-Fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue) Score for Participants Who Completed Neoadjuvant Chemotherapy | 6, 12, 18 and 24 months after randomisation (data cut off: 12 July 2021) | 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. |
| Secondary | Change From Baseline for FACIT-Fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue) Score for Participants Who Completed Adjuvant Chemotherapy | 6, 12, 18 and 24 months after randomisation (data cut off: 12 July 2021) | 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. |
| Secondary | 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 | 6, 12, 18 and 24 months after randomisation (data cut off: 12 July 2021) | 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. |
| Secondary | 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 | 6, 12, 18 and 24 months after randomisation (data cut off: 12 July 2021) | 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. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Invasive Disease Free Survival (IDFS) | From date of randomisation to data cut off: 27 March 2020 (approximately 5 years 11 months) | Full Analysis Set (FAS) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Distant Disease Free Survival (DDFS) | From date of randomisation to data cut off: 27 March 2020 (approximately 5 years 11 months) | Full Analysis Set (FAS) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival (OS) | From date of randomisation to data cut off: 12 July 2021 (approximately 7 years 3 months) | Full Analysis Set (FAS) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 | From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months) | Full Analysis Set (FAS) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline for FACIT-Fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue) Score for Participants Who Completed Neoadjuvant Chemotherapy | 6, 12, 18 and 24 months after randomisation (data cut off: 12 July 2021) | Patient reported outcomes (PRO) Analysis Set | Scores on a scale | MEAN |
| SECONDARY | Change From Baseline for FACIT-Fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue) Score for Participants Who Completed Adjuvant Chemotherapy | 6, 12, 18 and 24 months after randomisation (data cut off: 12 July 2021) | Patient reported outcomes (PRO) Analysis Set | Scores on a scale | MEAN |
| SECONDARY | 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 | 6, 12, 18 and 24 months after randomisation (data cut off: 12 July 2021) | Patient reported outcomes (PRO) Analysis Set | Scores on a scale | MEAN |
| SECONDARY | 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 | 6, 12, 18 and 24 months after randomisation (data cut off: 12 July 2021) | Patient reported outcomes (PRO) Analysis Set | Scores on a scale | MEAN |
Source ClinicalTrials.gov
Results by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Invasive Disease Free Survival (IDFS) | Olaparib | 106 | Participants | ||
| Invasive Disease Free Survival (IDFS) | Placebo | 178 | Participants | ||
| Distant Disease Free Survival (DDFS) | Olaparib | 89 | Participants | ||
| Distant Disease Free Survival (DDFS) | Placebo | 152 | Participants | ||
| Overall Survival (OS) | Olaparib | 75 | Participants | ||
| Overall Survival (OS) | Placebo | 109 | Participants | ||
| 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 | Olaparib | Contralateral invasive breast cancer | 31 | Participants | |
| 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 | Placebo | Contralateral invasive breast cancer | 40 | Participants | |
| 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 | Olaparib | Contralateral non-invasive breast cancer | 3 | Participants | |
| 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 | Placebo | Contralateral non-invasive breast cancer | 4 | Participants |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Olaparib | 921 | |
| Overall Study | STARTED | Placebo | 915 | |
| Overall Study | COMPLETED | Olaparib | 0 | |
| Overall Study | COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | Olaparib | 921 | |
| Overall Study | NOT COMPLETED | Placebo | 915 |
Source ClinicalTrials.gov
Adverse events292
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Olaparib | 86 | 911 | 96 |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 65 | 904 | 77 |
| other | Anaemia | Blood and lymphatic system disorders | Olaparib | 201 | 911 | 262 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 34 | 904 | 39 |
| other | Constipation | Gastrointestinal disorders | Olaparib | 85 | 911 | 90 |
| other | Constipation | Gastrointestinal disorders | Placebo | 80 | 904 | 91 |
| other | Diarrhoea | Gastrointestinal disorders | Olaparib | 160 | 911 | 198 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 125 | 904 | 163 |
| other | Dyspepsia | Gastrointestinal disorders | Olaparib | 55 | 911 | 62 |
| other | Dyspepsia | Gastrointestinal disorders | Placebo | 37 | 904 | 39 |
1 to 10 of 292Source ClinicalTrials.gov
See all 292 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Olaparib | 107 | 921 |
| Total, all-cause mortality | Placebo | 143 | 915 |
| Total, other adverse events | Olaparib | 794 | 911 |
| Total, other adverse events | Placebo | 674 | 904 |
| Total, serious adverse events | Olaparib | 79 | 911 |
| Total, serious adverse events | Placebo | 79 | 904 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Olaparib vs Placebo: Distant Disease Free Survival (DDFS) | Trial comparisons |
| Olaparib vs Placebo: Invasive Disease Free Survival (IDFS) | Trial comparisons |
| Olaparib vs Placebo: Overall Survival (OS) | Trial comparisons |
| Olaparib vs Placebo: deaths from any cause | Trial comparisons |
| Olaparib vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02032823
GET https://conductscience.org/api/trials/v1/NCT02032823/results?page=2