A Phase 3 interventional study of Olaparib in HER2-ve Metastatic Breast Cancer, Germline BRCA1/2 Mutations and Somatic BRCA1/2 Mutations, sponsored by AstraZeneca. Completed at 123 sites in 15 countries. Open to participants aged 18 Years to 130 Years. Per ClinicalTrials.gov, last updated 2023-01-17.
Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
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 7th largest by enrollment, is one of 4 that started in 2018, is one of 5 in phase 3, and was the 23rd 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. 4 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 256 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 44th largest by enrollment of the 125 interventional ones that give a count, is one of 5 that started in 2018, is one of 46 in phase 3, and was the 119th 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.
This open-label, multi-centre phase IIIb study will assess the effectiveness, benefits and potential harms in the use of olaparib monotherapy treatment for patients with HER2-ve metastatic breast cancer associated with germline or somatic breast cancer susceptibility gene (gBRCA1/2 or sBRCA1/2) mutations.
The study is a phase IIIb, multicenter, single-arm, open-label study designed to evaluate the clinical effectiveness in a real-world setting of olaparib monotherapy in patients with confirmed germline or somatic breast cancer susceptibility gene (gBRCA1/2 or sBRCA1/2) mutations. This study will generate additional data to support other olaparib studies, which may help inform and guide clinical practice. Physician defined the progression-free survival (PFS) for gBRCAm patients is the primary outcome measure. Based on the prevalence of gBRCA1/2 mutations, it is estimated that up to 1400 patients may require screening in order to identify 250 gBRCA mutated patients and 20 sBRCA mutated patients. Patients will be administered two olaparib 150mg tablets in morning and evening of every day after a light meal. Dose reductions may be required for olaparib treatment related toxicities. Patients should continue to receive study treatment until documented physician-defined disease progression as assessed by the investigator (gBRCA mutated patients), RECIST1.1 disease progression (sBRCA mutated patients) or unacceptable toxicity, or for as long as they do not meet any other discontinuation criteria. A positive benefit/risk profile is expected and no ethical issues are identified from exposing patients to olaparib within the planned clinical study.
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.
Documented BRCA1/2 status
Patients must have normal organ and bone marrow function measured within 14 days prior to administration of study treatment as defined below:
Estimated CrCl = (140-age [years]) x weight (kg) (x F)a serum creatinine (mg/dL) x 72
a- where F=0.85 for females and F=1 for males
or evidence of non-childbearing status for women of : negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on Day 1
Postmenopausal is defined as (at least one criterion met):
Exclusion criteria:
Patients with symptomatic uncontrolled .
Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection.
Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on high resolution computed tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining .
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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 recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
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.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
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.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
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.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
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.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
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.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Olaparib 150mg tablets administered orally twice daily continuously
Drug: Olaparib
Patients will be administered olaparib orally, twice daily at 300 mg. Two (2) 150 mg olaparib tablets should be taken at the same time each morning and evening of every day, approximately 12 hours apart.
Progression-free Survival (PFS) in Real-world Setting in Germline BRCA Mutated Participants
The clinical effectiveness of olaparib treatment in HER2-ve metastatic breast cancer participants in a real-world setting through assessment of PFS in germline BRCA mutated patients was evaluated. PFS is defined as the time from first dose of olaparib to the date of progression or death from any cause. In this study, disease progression in gBRCAm patients will be based on Investigator assessment, i.e. radiological ( e.g. RECIST) progression, symptomatic progression, or clear progression of non-measurable disease, as long as progression can be documented.
Time frame: At every visit until the earliest of disease progression, death or end of study (up to 3 years)
Overall Survival (OS) in Germline BRCA Mutated Participants
The clinical effectiveness of olaparib treatment in HER2-ve metastatic breast cancer participants in a real-world setting by assessment of overall survival in germline BRCA mutated participants was determined. OS is defined as the time from first dose of olaparib to the date of death from any cause.
Time frame: At every visit and until death or end of study (up to 3 years)
Time to First Subsequent Treatment or Death (TFST) in Germline BRCA Mutated Participants
The clinical effectiveness of olaparib treatment in HER2-ve metastatic breast cancer participants in a real-world setting by assessment of time to use of subsequent therapies, second progression, and study treatment discontinuation in germline BRCA mutated participants was determined. TFST is defined as the time from first dose of olaparib to first subsequent treatment commencement or death if this occurs before commencement of first subsequent treatment.
Time frame: At every visit until start of first subsequent anticancer treatment or death or end of study (up to 3 years)
Time to Second Subsequent Treatment or Death (TSST) in Germline BRCA Mutated Participants
The clinical effectiveness of olaparib treatment in HER2-ve metastatic breast cancer participants in a real-world setting by assessment of time to use of subsequent therapies, second progression, and study treatment discontinuation in germline BRCA mutated participants was determined. TSST is defined as the time from first dose of olaparib to second subsequent treatment commencement or death if this occurs before commencement of second subsequent treatment.
Time frame: At every visit until start of second subsequent anticancer treatment or death or end of study (up to 3 years)
Time to Study Treatment Discontinuation or Death (TDT) in Germline BRCA Mutated Participants
The clinical effectiveness of olaparib treatment in HER2-ve metastatic breast cancer participants in a real-world setting by assessment of time to use of subsequent therapies, second progression, and study treatment discontinuation in germline BRCA mutated patients was determined. TDT is defined as the time from first dose of olaparib to study treatment discontinuation or death if this occurs before discontinuation of study treatment.
Time frame: At every visit and until discontinuation of study treatment or death or end of study (up to 3 years)
Time to Second Progression or Death (PFS2) in Germline BRCA Mutated Participants
The clinical effectiveness of olaparib treatment in HER2-ve metastatic breast cancer participants in a real-world setting by assessment of time to use of subsequent therapies, second progression, and study treatment discontinuation in germline BRCA mutated participants was determined. PFS2 is defined as the time from first dose of olaparib to the earliest progression event subsequent to that used for the primary variable PFS or death from any cause. Patients alive and for whom a second disease progression has not been observed will be censored at the last time known to be alive and without a second disease progression. In this study, disease progression in gBRCAm patients will be based on Investigator assessment, i.e. radiological ( e.g. RECIST) progression, symptomatic progression, or clear progression of non-measurable disease, as long as progression can be documented
Time frame: At every visit until second progression or death or end of study (up to 3 years)
Clinical Response Rate (CRR) in Germline BRCA Mutated Participants
The clinical effectiveness of olaparib treatment in HER2-ve metastatic breast cancer participants in a real-world setting by assessment of clinical response rate and duration of clinical response in germline BRCA mutated participants was determined. CRR is defined as the percentage of patients assessed by the Investigator as responding. Response in gBRCAm patients were based on the Investigator's assessment. Data obtained up until progression, or last evaluable assessment in the absence of progression, will be included in the assessment of CRR. However, any responses, which occurred after a further anticancer therapy was received, will not be included in the numerator for the CRR calculation.
Time frame: At every visit until disease progression or death or end of study (up to 3 years)
Duration of Clinical Response (DoCR) in Germline BRCA Mutated Participants
The clinical effectiveness of olaparib treatment in HER2-ve metastatic breast cancer participants in a real-world setting by assessment of clinical response rate and duration of clinical response in germline BRCA mutated participants was determined. DoCR is defined as the time from the date the Investigator first assessed the patient as responding to the date the Investigator assessed the patient as progressing or the date of death from any cause. The end of response should coincide with the date of progression or death used for the PFS endpoint. The time of the initial response will be defined as the latest of the dates contributing towards the first visit response. If a patient does not progress following a response, they will be censored at the PFS censoring date.
Time frame: At every visit until disease progression or death or end of study (up to 3 years)
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
The safety and tolerability of olaparib treatment in HER2-ve metastatic breast cancer patients in a real-word setting was evaluated.
Time frame: From Screening (Day -28 to Day -1) until post DCO [up to 3 years]
Participants were enrolled in this study from 17-January-2018 to 21-March-2019 in 125 sites in 15 countries.
| Milestone | Olaparib |
|---|---|
| Started | 255 |
| Completed | 175 |
| Not completed | 80 |
| Withdrew: Patients rolled over to another study | 80 |
The clinical effectiveness of olaparib treatment in HER2-ve metastatic breast cancer participants in a real-world setting through assessment of PFS in germline BRCA mutated patients was evaluated. PFS is defined as the time from first dose of olaparib to the date of progression or death from any cause. In this study, disease progression in gBRCAm patients will be based on Investigator assessment, i.e. radiological ( e.g. RECIST) progression, symptomatic progression, or clear progression of non-measurable disease, as long as progression can be documented.
| months | Olaparib gBRCAm Cohort |
|---|---|
| Progression-free Survival (PFS) in Real-world Setting in Germline BRCA Mutated Participants | 8.18 (6.97 to 9.17) |
The clinical effectiveness of olaparib treatment in HER2-ve metastatic breast cancer participants in a real-world setting by assessment of overall survival in germline BRCA mutated participants was determined. OS is defined as the time from first dose of olaparib to the date of death from any cause.
| months | Olaparib gBRCAm Cohort |
|---|---|
| Overall Survival (OS) in Germline BRCA Mutated Participants | 24.94 (21.06 to 28.91) |
The clinical effectiveness of olaparib treatment in HER2-ve metastatic breast cancer participants in a real-world setting by assessment of time to use of subsequent therapies, second progression, and study treatment discontinuation in germline BRCA mutated participants was determined. TFST is defined as the time from first dose of olaparib to first subsequent treatment commencement or death if this occurs before commencement of first subsequent treatment.
| months | Olaparib gBRCAm Cohort |
|---|---|
| Time to First Subsequent Treatment or Death (TFST) in Germline BRCA Mutated Participants | 9.40 (8.61 to 10.64) |
The clinical effectiveness of olaparib treatment in HER2-ve metastatic breast cancer participants in a real-world setting by assessment of time to use of subsequent therapies, second progression, and study treatment discontinuation in germline BRCA mutated participants was determined. TSST is defined as the time from first dose of olaparib to second subsequent treatment commencement or death if this occurs before commencement of second subsequent treatment.
| months | Olaparib gBRCAm Cohort |
|---|---|
| Time to Second Subsequent Treatment or Death (TSST) in Germline BRCA Mutated Participants | 14.72 (13.50 to 17.25) |
The clinical effectiveness of olaparib treatment in HER2-ve metastatic breast cancer participants in a real-world setting by assessment of time to use of subsequent therapies, second progression, and study treatment discontinuation in germline BRCA mutated patients was determined. TDT is defined as the time from first dose of olaparib to study treatment discontinuation or death if this occurs before discontinuation of study treatment.
| months | Olaparib gBRCAm Cohort |
|---|---|
| Time to Study Treatment Discontinuation or Death (TDT) in Germline BRCA Mutated Participants | 7.98 (6.90 to 8.54) |
The clinical effectiveness of olaparib treatment in HER2-ve metastatic breast cancer participants in a real-world setting by assessment of time to use of subsequent therapies, second progression, and study treatment discontinuation in germline BRCA mutated participants was determined. PFS2 is defined as the time from first dose of olaparib to the earliest progression event subsequent to that used for the primary variable PFS or death from any cause. Patients alive and for whom a second disease progression has not been observed will be censored at the last time known to be alive and without a second disease progression. In this study, disease progression in gBRCAm patients will be based on Investigator assessment, i.e. radiological ( e.g. RECIST) progression, symptomatic progression, or clear progression of non-measurable disease, as long as progression can be documented
| months | Olaparib gBRCAm Cohort |
|---|---|
| Time to Second Progression or Death (PFS2) in Germline BRCA Mutated Participants | 14.49 (13.17 to 17.05) |
The clinical effectiveness of olaparib treatment in HER2-ve metastatic breast cancer participants in a real-world setting by assessment of clinical response rate and duration of clinical response in germline BRCA mutated participants was determined. CRR is defined as the percentage of patients assessed by the Investigator as responding. Response in gBRCAm patients were based on the Investigator's assessment. Data obtained up until progression, or last evaluable assessment in the absence of progression, will be included in the assessment of CRR. However, any responses, which occurred after a further anticancer therapy was received, will not be included in the numerator for the CRR calculation.
| Percentage of participants | Olaparib gBRCAm Cohort |
|---|---|
| Clinical Response Rate (CRR) in Germline BRCA Mutated Participants | 49.6 (43.3 to 55.9) |
The clinical effectiveness of olaparib treatment in HER2-ve metastatic breast cancer participants in a real-world setting by assessment of clinical response rate and duration of clinical response in germline BRCA mutated participants was determined. DoCR is defined as the time from the date the Investigator first assessed the patient as responding to the date the Investigator assessed the patient as progressing or the date of death from any cause. The end of response should coincide with the date of progression or death used for the PFS endpoint. The time of the initial response will be defined as the latest of the dates contributing towards the first visit response. If a patient does not progress following a response, they will be censored at the PFS censoring date.
| Months | Olaparib gBRCAm Cohort |
|---|---|
| Duration of Clinical Response (DoCR) in Germline BRCA Mutated Participants | 8.0 (4.2 to 18.6) |
The safety and tolerability of olaparib treatment in HER2-ve metastatic breast cancer patients in a real-word setting was evaluated.
| Participants | Olaparib gBRCAm Cohort | Olaparib sBRCAm Cohort |
|---|---|---|
| Any AE | 243 | 3 |
| Any AE casually related to study treatment | 214 | 3 |
| Any AE of CTCAE grade 3 or higher | 69 | 2 |
| Any AE of CTCAE grade 3 or higher, causally related to study treatment | 44 | 1 |
| Any AE with outcome = death | 0 | 0 |
| Any AE with outcome = death, causally related to study treatment | 0 | 0 |
| Any SAE (including events with outcome = death) | 32 | 1 |
| Any SAE (including events with outcome = death), causally related to study treatment | 10 | 0 |
| Any AE leading to discontinuation of study treatment | 16 | 0 |
| Any AE leading to discontinuation of study treatment, causally related to study treatment | 11 | 0 |
Collected over From Screening (Day -28 to -1) until post DCO [up to 3 years].. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Olaparib gBRCAm Cohort | 140/252 (55.6%) | 32/252 (12.7%) | 243/252 (96.4%) |
| Olaparib sBRCAm Cohort | 2/3 (66.7%) | 1/3 (33.3%) | 3/3 (100%) |
| Event | Olaparib gBRCAm Cohort | Olaparib sBRCAm Cohort |
|---|---|---|
| General physical condition abnormalInvestigations | 0/252 | 1/3 |
| AnaemiaBlood and lymphatic system disorders | 7/252 | 0/3 |
| Febrile neutropeniaBlood and lymphatic system disorders | 2/252 | 0/3 |
| VomitingGastrointestinal disorders | 2/252 | 0/3 |
| AstheniaGeneral disorders | 2/252 | 0/3 |
| AbscessInfections and infestations | 1/252 | 0/3 |
| COVID-19Infections and infestations | 1/252 | 0/3 |
| COVID-19 pneumoniaInfections and infestations | 1/252 | 0/3 |
| CellulitisInfections and infestations | 1/252 | 0/3 |
| Chest wall abscessInfections and infestations | 1/252 | 0/3 |
| Event | Olaparib gBRCAm Cohort | Olaparib sBRCAm Cohort |
|---|---|---|
| ConstipationGastrointestinal disorders | 30/252 | 3/3 |
| HeadacheNervous system disorders | 47/252 | 2/3 |
| DiarrhoeaGastrointestinal disorders | 53/252 | 2/3 |
| NauseaGastrointestinal disorders | 140/252 | 2/3 |
| MyalgiaMusculoskeletal and connective tissue disorders | 17/252 | 2/3 |
| AstheniaGeneral disorders | 70/252 | 2/3 |
| AnaemiaBlood and lymphatic system disorders | 98/252 | 1/3 |
| NeutropeniaBlood and lymphatic system disorders | 41/252 | 1/3 |
| CoughRespiratory, thoracic and mediastinal disorders | 35/252 | 1/3 |
| Abdominal painGastrointestinal disorders | 21/252 | 1/3 |
The Full Analysis Set consisted of all participants who received at least one dose of study treatment.
| Age, Continuous(years) | Olaparib |
|---|---|
| Germline BRCA1/2 mutation (gBRCAm) cohort | 46.2 ± 11.30 |
| Somatic BRCA1/2 mutation (sBRCAm) cohort | 55.3 ± 13.01 |
| Sex: Female, Male(Participants) | Olaparib |
|---|---|
| gBRCAm cohort — Female | 248 |
| gBRCAm cohort — Male | 4 |
| sBRCAm cohort — Female | 3 |
| sBRCAm cohort — Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | Olaparib |
|---|---|
| gBRCAm cohort — Hispanic or Latino | 13 |
| gBRCAm cohort — Not Hispanic or Latino | 189 |
| gBRCAm cohort — Unknown or Not Reported | 50 |
| sBRCAm cohort — Hispanic or Latino | 0 |
| sBRCAm cohort — Not Hispanic or Latino | 1 |
| sBRCAm cohort — Unknown or Not Reported | 2 |
| Race (NIH/OMB)(Participants) | Olaparib |
|---|---|
| gBRCAm cohort — American Indian or Alaska Native | 1 |
| gBRCAm cohort — Asian | 22 |
| gBRCAm cohort — Native Hawaiian or Other Pacific Islander | 0 |
| gBRCAm cohort — Black or African American | 2 |
| gBRCAm cohort — White | 177 |
| gBRCAm cohort — More than one race | 0 |
| gBRCAm cohort — Unknown or Not Reported | 50 |
| sBRCAm cohort — American Indian or Alaska Native | 0 |
| sBRCAm cohort — Asian | 1 |
| sBRCAm cohort — Native Hawaiian or Other Pacific Islander | 0 |
| sBRCAm cohort — Black or African American | 0 |
| sBRCAm cohort — White | 0 |
| sBRCAm cohort — More than one race | 0 |
| sBRCAm cohort — Unknown or Not Reported | 2 |
Showing the first 100 of 123 sites across 15 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.
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 Jan 2018 to primary completion in Oct 2021, 44 months.
Results were first posted in Jan 2023, 1 year 3 months after primary completion.
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 44 months is close to 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 completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
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