A Phase 3 interventional study of Olaparib and Placebo in Breast Cancer, sponsored by AstraZeneca. Active, not recruiting at 698 sites in 24 countries. Open to participants aged 18 Years to 130 Years. Per ClinicalTrials.gov, last updated 2026-07-14.
Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment
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Among 51 studies testing olaparib in Breast Neoplasms — 11 open to participants now, 25 under way, 4 of them phase 3. olaparib · Breast Neoplasms.
Among the 51 studies testing olaparib in Breast Neoplasms, this one is the 2nd largest by enrollment, is one of 3 that started in 2014, is one of 5 in phase 3, reaches primary completion later than 0 of the 24 other live ones, and was the 10th registered.
14,832 studies on the registry are indexed under Breast Neoplasms; 3,320 are open to participants now.
Browse Breast Neoplasms studies →11 of the 51 studies testing olaparib in Breast Neoplasms are open now, in 8 countries. Recruiting first, the newest first:
Wen-Ming Cao · Sites in China
Ages 60+ · Women only
Okayama University · Sites in Japan
Ages 18+
Mary D Chamberlin · Sites in United States
Ages 18+ · Women only
German Cancer Research Center · Sites in Germany
Ages 18+
National Taiwan University Hospital · Sites in Taiwan
Ages 20+
By country, each count listing its studies:
olaparib: first FDA approval 2014 (LYNPARZA), first EMA approval 2014. What it is approved for, and how studies give it, is on its page →
Of the 2,399 Breast Neoplasms studies recruiting now, 1,570 (65%) set no upper age limit and 592 (25%) stop at 75 or younger; 103 take children under 18; 215 take healthy volunteers.
This study: 18 Years to 130 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
On this site’s reading of the record, olaparib is the treatment under test here. Read study by study →
51 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 18 · Phase 2 27 · Phase 3 6 · Phase 4 3
First in 2007; this study’s year is marked. 3 started in 2014.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 1,837 is above the median of 72 across 10,903 interventional studies indexed under Breast Neoplasms.
Median enrollment 54 across the 51 interventional studies. Of the 24 that completed or were terminated, 10 (42%) have results posted.
This tab as a report to print or save as PDF → With an account.
12 of 51 have an industry lead sponsor. The 10 most frequent:
AstraZeneca is the lead sponsor of 3,503 studies on the registry; 273 are open to participants now.
Of its 369 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
198 studies in Breast Neoplasms by AstraZeneca: 20 open now, 50 under way, 24 of them phase 3. Of 144 finished, 32 (22%) have results posted.
Among the 198 studies in Breast Neoplasms by AstraZeneca, this one is the 8th largest by enrollment of the 125 interventional ones that give a count, is one of 5 that started in 2014, is one of 46 in phase 3, reaches primary completion later than 1 of the 49 other live ones, and was the 104th registered.
AstraZeneca’s Breast Neoplasms studies by the year they started, since 1996.
4 of the studies testing olaparib in Breast Neoplasms that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04421963Phase 3AstraZenecaRoll Over StudY for Patients Who Have Completed a Previous Oncology Study With Olaparib | 2027-04-06 |
| NCT03740893Institute of Cancer Research, United KingdomPHOENIX DDR/Anti-PD-L1 Trial: A Pre-surgical Window of Opportunity and Post-surgical Adjuvant Biomarker Study of DNA Damage Response Inhibition With or Without Anti-PD-L1 Immunotherapy in Patients With Neoadjuvant Treatment Resistant Residual Triple Negative Breast Cancer | 2026-12 |
| NCT03594396Seoul National University HospitalWindow of Opportunity Trial of Neoadjuvant Olaparib and Durvalumab for Triple Negative or Low ER+ Breast Cancer | 2026-12-31 |
| NCT04683679Memorial Sloan Kettering Cancer CenterA Study of Radiation Therapy With Pembrolizumab and Olaparib or Other Radiosensitizers in Women Who Have Triple-Negative or Hormone-Receptor Positive/Her2 Negative Breast Cancer | 2027-01 |
Add all 4 to your calendar (.ics) → With an account.
Among the 51 studies testing olaparib in Breast Neoplasms, from their registry updates:
Among AstraZeneca’s 198 in Breast Neoplasms:
This tab as a report to print or save as PDF → With an account.
Olaparib treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy
Patients will be randomised in 1:1 ratio to either olaparib or placebo. Randomisation will be stratified by Hormone receptor status (ER and/or PgR positive/HER2 negative versus TNBC), prior neoadjuvant versus adjuvant chemotherapy and prior platinum use for breast cancer.
Randomised patients will receive study treatment for up to a maximum of 12 months. All patients will have safety assessments every 2 weeks during the first month, every 4 weeks for the following 5 months and 3 monthly for the remaining 6 months of study treatment plus 30 days after its discontinuation. Following randomisation, all patients will be assessed regularly for signs, symptoms and evidence of disease recurrence by taking medical history, physical examination and mammogram/breast MRI. Efficacy assessments will be performed on a 3 monthly basis during the first 2 years, followed by 6 monthly assessments for years 3, 4 and 5 and annually thereafter. All patients (except those with bilateral mastectomy) will have mammogram / breast MRI annually for 10 years beginning 6 months after randomisation.
All randomised patients will have clinical assessment visits for 10 years following their randomisation into the study. Once a patient completes 10 years of clinical assessment they will enter the survival follow up phase of the trial which will continue until approximately 10 years after the last patient is randomised.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
confirmed non- primary invasive adenocarcinoma of the breast that is one of the following phenotypes:
Exclusion criteria:
Patients with second primary . EXCEPTIONS are:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Olaparib tablets 300mg b.i.d. p.o.
Drug: Olaparib
Placebo tablets b.i.d. p.o.
Drug: Placebo
Patients will be administred olaparib orally twice daily (b.i.d.) at 300 mg. Two (2) x 150 mg olaparib tablets should be taken at the same times each morning and evening of each day, approximately 12 hours apart with approximately 240 ml of water
Also known as: Lynparza
Patients will be administred matching placebo. Two (2) tablets should be taken at the same times each morning and evening of each day, approximately 12 hours apart with approximately 240 ml of water
Invasive Disease Free Survival (IDFS)
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)
Distant Disease Free Survival (DDFS)
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)
Overall Survival (OS)
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)
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
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: 05 June 2024 (approximately 10 years 2 months)
Change From Baseline for FACIT-Fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue) Score for Participants Who Completed Neoadjuvant Chemotherapy
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)
Change From Baseline for FACIT-Fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue) Score for Participants Who Completed Adjuvant Chemotherapy
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)
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
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)
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
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)
The first patient was enrolled on 22 April 2014. Patients were randomised from 554 centres in 23 countries worldwide.
| Milestone | Olaparib | Placebo |
|---|---|---|
| Started | 921 | 915 |
| Completed | 0 | 0 |
| Not completed | 921 | 915 |
| Withdrew: Death | 107 | 143 |
| Withdrew: Lost to follow-up | 36 | 36 |
| Withdrew: Withdrawal by subject | 78 | 64 |
| Withdrew: Ongoing study at the data cut-off (dco3: 05jun2024) | 697 | 666 |
| Withdrew: Other (e.g investigators decision, protocol deviation, randomised by mistake) | 3 | 6 |
An IDFS event is defined as the first occurrence of loco-regional or distant recurrence or new cancer or death from any cause.
| Participants | Olaparib | Placebo |
|---|---|---|
| Invasive Disease Free Survival (IDFS) | 106 | 178 |
A DDFS event is defined as documented evidence of first distant recurrence of breast cancer or death from any cause
| Participants | Olaparib | Placebo |
|---|---|---|
| Distant Disease Free Survival (DDFS) | 89 | 152 |
An OS event is defined as death by any cause.
| Participants | Olaparib | Placebo |
|---|---|---|
| Overall Survival (OS) | 75 | 109 |
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.
| Participants | Olaparib | Placebo |
|---|---|---|
| Contralateral invasive breast cancer | 31 | 40 |
| Contralateral non-invasive breast cancer | 3 | 4 |
| New primary ovarian cancer | 3 | 9 |
| New primary fallopian tube cancer | 1 | 4 |
| New primary peritoneal cancer | 0 | 0 |
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.
| Scores on a scale | Olaparib | Placebo |
|---|---|---|
| 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 | -1.5 (-2.4 to -0.6) | 0.0 (-0.9 to 0.9) |
| 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 | 1.6 (0.7 to 2.4) | 2.0 (1.1 to 2.9) |
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.
| Scores on a scale | Olaparib | Placebo |
|---|---|---|
| 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) |
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.
| Scores on a scale | Olaparib | Placebo |
|---|---|---|
| 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) |
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.
| Scores on a scale | Olaparib | Placebo |
|---|---|---|
| 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) |
Collected over From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Olaparib | 107/921 (11.6%) | 79/911 (8.7%) | 794/911 (87.2%) |
| Placebo | 143/915 (15.6%) | 79/904 (8.7%) | 674/904 (74.6%) |
| Event | Olaparib | Placebo |
|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 15/911 | 1/904 |
| MastitisInfections and infestations | 3/911 | 6/904 |
| Wound dehiscenceInjury, poisoning and procedural complications | 1/911 | 4/904 |
| Malignant melanomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/911 | 4/904 |
| Ovarian cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/911 | 4/904 |
| Abdominal painGastrointestinal disorders | 0/911 | 3/904 |
| PyrexiaGeneral disorders | 1/911 | 3/904 |
| Breast cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/911 | 3/904 |
| Febrile neutropeniaBlood and lymphatic system disorders | 3/911 | 0/904 |
| Device related infectionInfections and infestations | 3/911 | 2/904 |
| Event | Olaparib | Placebo |
|---|---|---|
| NauseaGastrointestinal disorders | 519/911 | 213/904 |
| FatigueGeneral disorders | 367/911 | 248/904 |
| VomitingGastrointestinal disorders | 204/911 | 74/904 |
| AnaemiaBlood and lymphatic system disorders | 201/911 | 34/904 |
| HeadacheNervous system disorders | 178/911 | 151/904 |
| DiarrhoeaGastrointestinal disorders | 160/911 | 125/904 |
| Neutrophil count decreasedInvestigations | 148/911 | 59/904 |
| White blood cell count decreasedInvestigations | 145/911 | 53/904 |
| Decreased appetiteMetabolism and nutrition disorders | 120/911 | 53/904 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 88/911 | 114/904 |
Full Analysis Set (FAS)
| Age, Continuous(Years) | Olaparib | Placebo | Total |
|---|---|---|---|
| Mean | 43.0 ± 9.8 | 43.6 ± 10.1 | 43.3 ± 10.0 |
| Age, Customized(Participants) | Olaparib | Placebo | Total |
|---|---|---|---|
| <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(Participants) | Olaparib | Placebo | Total |
|---|---|---|---|
| Female | 919 | 911 | 1830 |
| Male | 2 | 4 | 6 |
| Race/Ethnicity, Customized(Participants) | Olaparib | Placebo | Total |
|---|---|---|---|
| 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(Participants) | Olaparib | Placebo | Total |
|---|---|---|---|
| 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(Participants) | Olaparib | Placebo | Total |
|---|---|---|---|
| ARG | 16 | 12 | 28 |
| AUS | 30 | 30 | 60 |
| AUT | 28 | 25 | 53 |
| BEL | 12 | 26 | 38 |
| CAN | 11 | 23 | 34 |
| CHE | 4 | 17 | 21 |
| CHN | 117 | 130 | 247 |
| DEU | 106 | 92 | 198 |
| ESP | 63 | 46 | 109 |
| FRA | 77 | 65 | 142 |
| GBR | 60 | 46 | 106 |
| HUN | 8 | 9 | 17 |
| ISL | 5 | 1 | 6 |
| ISR | 30 | 35 | 65 |
| ITA | 30 | 27 | 57 |
| JPN | 64 | 76 | 140 |
| KOR | 53 | 44 | 97 |
| NLD | 11 | 18 | 29 |
| POL | 50 | 59 | 109 |
| PRT | 7 | 6 | 13 |
| SWE | 20 | 15 | 35 |
| TWN | 8 | 4 | 12 |
| USA | 111 | 109 | 220 |
Showing the first 100 of 698 sites across 24 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Supporting information: Study protocol, Statistical analysis plan
Time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Data sharing details ↗ · astrazenecagroup-dt.pharmacm.com
Ran from Apr 2014 to primary completion in Mar 2020, 71 months.
Results were first posted in Dec 2021, 1 year 8 months after primary completion. A results delay was requested in Mar 2021.
Of 272 industry-sponsored phase 3 interventional studies under Breast Neoplasms, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 63. This study's 71 months is above that.
Counting every sponsor, half of 600 studies reached it within 59 months; a quarter within 36 and three quarters within 96.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Olaparib