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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03286842
Registration number
NCT03286842
Ethics application status
Date submitted
17/08/2017
Date registered
19/09/2017
Date last updated
17/01/2023
Titles & IDs
Public title
To Study Clinical Effectiveness and Safety of Olaparib Monotherapy in Metastatic Breast Cancer Patients.
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Scientific title
A Phase IIIb, Single-arm, Open-label Multicentre Study of Olaparib Monotherapy in the Treatment of HER2-ve Metastatic Breast Cancer Patients With Germline or Somatic BRCA1/2 Mutations.
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Secondary ID [1]
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D0816C00018
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
HER2-ve Metastatic Breast Cancer
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Germline BRCA1/2 Mutations
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Somatic BRCA1/2 Mutations
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Condition category
Condition code
Cancer
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Breast
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Olaparib
Experimental: Olaparib - Olaparib 150mg tablets administered orally twice daily continuously
Treatment: Drugs: 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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-free Survival (PFS) in Real-world Setting in Germline BRCA Mutated Participants
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Assessment method [1]
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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.
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Timepoint [1]
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At every visit until the earliest of disease progression, death or end of study (up to 3 years)
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Secondary outcome [1]
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Overall Survival (OS) in Germline BRCA Mutated Participants
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Assessment method [1]
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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.
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Timepoint [1]
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At every visit and until death or end of study (up to 3 years)
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Secondary outcome [2]
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Time to First Subsequent Treatment or Death (TFST) in Germline BRCA Mutated Participants
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Assessment method [2]
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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.
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Timepoint [2]
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At every visit until start of first subsequent anticancer treatment or death or end of study (up to 3 years)
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Secondary outcome [3]
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Time to Second Subsequent Treatment or Death (TSST) in Germline BRCA Mutated Participants
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Assessment method [3]
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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.
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Timepoint [3]
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At every visit until start of second subsequent anticancer treatment or death or end of study (up to 3 years)
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Secondary outcome [4]
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Time to Study Treatment Discontinuation or Death (TDT) in Germline BRCA Mutated Participants
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Assessment method [4]
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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.
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Timepoint [4]
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At every visit and until discontinuation of study treatment or death or end of study (up to 3 years)
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Secondary outcome [5]
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Time to Second Progression or Death (PFS2) in Germline BRCA Mutated Participants
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Assessment method [5]
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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
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Timepoint [5]
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At every visit until second progression or death or end of study (up to 3 years)
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Secondary outcome [6]
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Clinical Response Rate (CRR) in Germline BRCA Mutated Participants
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Assessment method [6]
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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.
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Timepoint [6]
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At every visit until disease progression or death or end of study (up to 3 years)
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Secondary outcome [7]
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Duration of Clinical Response (DoCR) in Germline BRCA Mutated Participants
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Assessment method [7]
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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.
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Timepoint [7]
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At every visit until disease progression or death or end of study (up to 3 years)
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Secondary outcome [8]
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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
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Assessment method [8]
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The safety and tolerability of olaparib treatment in HER2-ve metastatic breast cancer patients in a real-word setting was evaluated.
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Timepoint [8]
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From Screening (Day -28 to Day -1) until post DCO [up to 3 years]
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Eligibility
Key inclusion criteria
Inclusion criteria:
1. Provision of informed consent prior to any study specific procedures. For patients
aged <20 years and screened in Japan, a written informed consent should be obtained
from the patient and his or her legally acceptable representative.
2. Patients must be =18 years of age.
3. Histologically or cytologically confirmed HER2-ve breast cancer with evidence of
metastatic disease. Patients can have either TNBC (defined as oestrogen receptor and
progesterone receptor negative [immunohistochemistry nuclear staining <1%] and HER2-ve
[immunohistochemistry 0, 1+ or 2+ and/or in situ hybridization nonamplified with ratio
less than 2.0]) or oestrogen receptor / progesterone receptor positive breast cancer
as long as they are HER2-ve.
4. Documented BRCA1/2 status
- To be regarded as BRCA1/2 (+ve), the patient must have a mutation that is
predicted to be deleterious or suspected deleterious (known or predicted to be
detrimental / lead to loss of function). Mutations that are not clearly
pathogenic may be assessed by a committee of genetic specialists to adjudicate if
the patient is eligible.
- Patients with tBRCA mutations: must be confirmed by a validated method (e.g.
results from a CLIA-certified laboratory or CE-IVD device)
5. Prior treatment with a taxane or an anthracycline in either an adjuvant (may include
neoadjuvant) or metastatic breast cancer treatment setting.
6. Patients should have received no more than two prior cytotoxic chemotherapy regimens
in the metastatic setting. If a patient has oestrogen receptor and/or progesterone
receptor positive HER2 negative metastatic breast cancer and has completed a prior
line of hormonal treatment, then if the current or currently planned choice of
treatment for the patient does not include a hormonal treatment then they would be a
suitable patient to enter the study. Previous endocrine therapy could be in either an
adjuvant or a metastatic setting and include endocrine therapy in combination with a
targeted agent such as a CDK4/6 or mTOR inhibitor.
7. Be considered suitable, by the Investigator, for further treatment with single-agent
chemotherapy for the metastatic disease
8. Patients must have normal organ and bone marrow function measured within 14 days prior
to administration of study treatment as defined below:
- Haemoglobin = 10.0 g/dL with no blood transfusion in the past 28 days
- Absolute neutrophil count (ANC) = 1.5 x 109/L
- Platelet count = 100 x 109/L
- Total bilirubin = 1.5 x institutional upper limit of normal (ULN) unless the
patient has documented Gilbert's Syndrome
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase (SGOT))
/ alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase (SGPT)) =
2.5 x institutional ULN unless liver metastases are present in which case they
must be = 5x ULN
- Patients must have creatinine clearance (CrCl) estimated using the Cockcroft-
Gault equation of = 51 mL/min or 24 hour urine test may be done if standard of
care:
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
9. Patients must have a life expectancy = 16 weeks
10. Postmenopausal or evidence of non-childbearing status for women of childbearing
potential: 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):
- amenorrhoeic for 1 year or more following cessation of exogenous hormonal
treatments
- luteinizing hormone and follicle stimulating hormone levels in the postmenopausal
range for women under 50
- radiation-induced oophorectomy with last menses >1 year ago
- chemotherapy-induced menopause with >1 year interval since last menses
- surgical sterilisation (bilateral oophorectomy or hysterectomy).
11. Women of childbearing potential, who are sexually active, must agree to the use of one
highly effective form of contraception and their male partners must use a condom from
the signing of the informed consent, throughout the period of taking study treatment
and for at least 1 month after last dose of study drug, or they must totally/truly
abstain from any form of sexual intercourse.
12. Male patients must use a condom during treatment and for 3 months after the last dose
of olaparib when having sexual intercourse with a pregnant woman or with a woman of
childbearing potential. Female partners of male patients should also use one highly
effective form of contraception if they are of childbearing potential.
13. Patient is willing and able to comply with the protocol for the duration of the study
including undergoing treatment and scheduled visits and examinations for greater than
6 months.
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Minimum age
18
Years
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Maximum age
130
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria:
1. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca
staff and/or staff at the study site)
2. Previous enrolment in the present study
3. Exposure to an investigational product (IP) during the last 1 month or 5 half-lives
(whichever is longer) prior to enrolment
4. Patients receiving any systemic chemotherapy or radiotherapy (except for palliative
reasons) within 3 weeks prior to study treatment
5. Any previous treatment with a PARP inhibitor, including olaparib
6. Other malignancy unless curatively treated with no evidence of disease for =5 years
except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer
of the cervix, ductal carcinoma in situ (DCIS), Stage 1, grade 1 endometrial
carcinoma.
7. Resting ECG indicating uncontrolled, potentially reversible cardiac conditions, as
judged by the investigator (e.g., unstable ischemia, uncontrolled symptomatic
arrhythmia, congestive heart failure, QTcF prolongation >500 ms, electrolyte
disturbances, etc.), or patients with congenital long QT syndrome.
8. Concomitant use of known strong CYP3A inhibitors (e.g., itraconazole, telithromycin,
clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir,
saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (e.g.,
ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout
period prior to starting olaparib is 2 weeks.
9. Concomitant use of known strong (e.g., phenobarbital, enzalutamide, phenytoin,
rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or
moderate CYP3A inducers (e.g., bosentan, efavirenz, modafinil). The required washout
period prior to starting olaparib is 5 weeks for enzalutamide or phenobarbital and 3
weeks for other agents.
10. Persistent toxicities (>Common Terminology Criteria for Adverse Event (CTCAE) grade 2)
caused by previous cancer therapy, excluding alopecia.
11. Patients with myelodysplastic syndrome (MDS)/acute myeloid leukaemia (AML) or with
features suggestive of MDS/AML
12. Patients with symptomatic uncontrolled brain metastases.
- Exception: Patients with adequately treated brain metastases documented by baseline
CT or MRI scan that has not progressed since previous scans and that does not require
corticosteroids (except =10 mg/day prednisone or equivalent for at least 14 continuous
days prior to dosing) for management of CNS symptoms are eligible, provided that a
repeat CT or MRI following the identification of CNS metastases (obtained at least 2
weeks after definitive therapy) must document adequately treated brain metastases.
13. Major surgery within 2 weeks of starting study treatment and patients must have
recovered from any effects of any major surgery.
14. 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 informed consent.
15. Patients unable to swallow orally administered medication and patients with
gastrointestinal disorders likely to interfere with absorption of the study medication
16. Breastfeeding women
17. Immunocompromised patients, e.g., patients who are known to be serologically positive
for human immunodeficiency virus (HIV)
18. Patients with a known hypersensitivity to olaparib or any of the excipients of the
product
19. Patients with known active hepatitis (i.e., hepatitis B or C)
20. Whole blood transfusions in the last 28 days prior to entry to the study.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
17/01/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
8/10/2021
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Sample size
Target
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Accrual to date
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Final
256
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
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Ryazan
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Russian Federation
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Samara
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Russian Federation
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Sankt-Peterburg
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Russian Federation
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St.Petersburg
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Russian Federation
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Surgut
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Russian Federation
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Ufa
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Spain
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Alicante
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Spain
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Barcelona
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Spain
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Cáceres
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Spain
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Granada
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Spain
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L'Hospitalet De Llobregat
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Spain
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Madrid
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Spain
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Majadahonda
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Spain
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Pamplona
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Spain
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San Cristóbal de La Laguna
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Spain
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Sevilla
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Spain
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Vigo
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Spain
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Zaragoza
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Taipei
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Taiwan
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Taoyuan City
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Turkey
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Adana
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Turkey
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Ankara
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Turkey
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Istanbul
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Turkey
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Izmir
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Turkey
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Kayseri
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Turkey
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Konya
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Turkey
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Mersin
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Turkey
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Tekirdag
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United Kingdom
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Cardiff.
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United Kingdom
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Colchester
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United Kingdom
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Edinburgh
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United Kingdom
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Glasgow
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United Kingdom
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Leeds
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United Kingdom
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London
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United Kingdom
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Manchester
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Country [108]
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United Kingdom
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Sutton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AstraZeneca
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Ethics approval
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03286842
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
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Karen Gelmon, MD, FRCPC
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Address
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BritishColumbiaCancerAgency, 600W.10th Ave,Vancouver,Canada.
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03286842
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