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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03286842




Registration number
NCT03286842
Ethics application status
Date submitted
17/08/2017
Date registered
14/09/2017
Date last updated
20/12/2018

Titles & IDs
Public title
To Study Clinical Effectiveness and Safety of Olaparib Monotherapy in Metastatic Breast Cancer Patients.
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.
Secondary ID [1] 0 0
D0816C00018
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HER2-ve Metastatic Breast Cancer 0 0
Germline BRCA1/2 Mutations 0 0
Somatic BRCA1/2 Mutations 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
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.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free survival (PFS) in real-world setting in germline BRCA mutated patients - PFS is defined as the time from the first dose of olaparib to physician-defined progression or death from any cause (in the absence of progression). Physician-defined progression can be RECIST progression, symptomatic progression, or clear progression of non measurable disease, as long as there is some manner of documenting all of them.
Timepoint [1] 0 0
At every visit until the earliest of disease progression, death or end of study for up to 3 years.
Secondary outcome [1] 0 0
Overall Survival (OS) in germline BRCA mutated patients - OS is defined as the time from first dose of olaparib to the date of death from any cause.
Timepoint [1] 0 0
At every visit and until death or end of study for up to 3 years.
Secondary outcome [2] 0 0
Time to first subsequent treatment or death (TFST) in germline BRCA mutated patients - 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.
Timepoint [2] 0 0
At every visit until start of first subsequent anticancer treatment or death or end of study for up to 3 years.
Secondary outcome [3] 0 0
Time to second subsequent treatment or death (TSST) in germline BRCA mutated patients - 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.
Timepoint [3] 0 0
At every visit until start of second subsequent anticancer treatment or death or end of study for up to 3 years.
Secondary outcome [4] 0 0
Time to study treatment discontinuation or death (TDT) in germline BRCA mutated patients - 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.
Timepoint [4] 0 0
At every visit and until discontinuation of study treatment or death or end of study for up to 3 years.
Secondary outcome [5] 0 0
Time to second progression or death (PFS2) in germline BRCA mutated patients - 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.
Timepoint [5] 0 0
At every visit until second progression or death or end of study for up to 3 years.
Secondary outcome [6] 0 0
Clinical response rate (CRR) in germline BRCA mutated patients - CRR is defined as the proportion of patients assessed by the Investigator as responding (physician-defined response, radiological [e.g. RECIST] or symptomatic).
Timepoint [6] 0 0
At every visit until disease progression or death or end of study for up to 3 years.
Secondary outcome [7] 0 0
Duration of clinical response (DoCR) in germline BRCA mutated patients - 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 (in the absence of progression).
Timepoint [7] 0 0
At every visit until disease progression or death or end of study for up to 3 years.
Secondary outcome [8] 0 0
Safety and tolerability of olaparib by assessment of adverse events - Assessment of adverse events (AEs), graded by Common Terminology Criteria for Adverse Event (CTCAE).
Timepoint [8] 0 0
At every visit until 30 days post last dose of study treatment.
Secondary outcome [9] 0 0
Laboratory assessment of haematology - To assess the hematology (haemoglobin, leukocyte count, absolute neutrophil count, absolute lymphocyte count, platelet count, and mean cell volume as a criteria of safety and tolerability of olaparib.
Timepoint [9] 0 0
At every visit up to and including 30 days post last dose of study medication.
Secondary outcome [10] 0 0
Laboratory assessment of clinical chemistry - To assess the clinical chemistry (creatinine, total bilirubin, alkaline phosphatase, aspartate transaminase, alanine transaminase, albumin, calcium, potassium, sodium, blood urea nitrogen, and total protein) as a criteria of safety and tolerability of olaparib.
Timepoint [10] 0 0
At screening, visit 2, as clinically indicated while on treatment, at treatment discontinuation and at 30 days post last dose of study medication.
Secondary outcome [11] 0 0
Laboratory assessment of urinalysis - To assess urinalysis (hemoglobin/erythrocytes/blood, protein/albumin, and glucose) as a criteria of safety and tolerability of olaparib.
Timepoint [11] 0 0
At screening

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 and their partners, who are sexually active, must
agree to the use of two highly effective forms of contraception in combination 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 a 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Randwick
Recruitment postcode(s) [1] 0 0
NSW 2031 - Randwick
Recruitment outside Australia
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California
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Madrid
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Pamplona
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Sevilla
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Valencia
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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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Taipei
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Tao Yuan
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Turkey
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Adana
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Ankara
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Istanbul
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Izmir
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Manchester
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Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT03286842
Trial related presentations / publications
Public notes

Contacts
Principal investigator
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Karen Gelmon, MD, FRCPC
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BritishColumbiaCancerAgency, 600W.10th Ave,Vancouver,Canada.
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Phone 0 0
Fax 0 0
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Contact person for public queries
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AstraZeneca Clinical Study Information Center
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Country 0 0
Phone 0 0
1-877-240-9479
Fax 0 0
Email 0 0
information.center@astrazeneca.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03286842