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Trial details imported from

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Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
Phase I/II Study of AZD2281 Given in Combination With Paclitaxel in Metastatic Triple Negative Breast Cancer
Scientific title
Phase I/II Randomised, Double- Blind, Multi-centre Study to Assess the Efficacy of AZD2281 When Given in Combination With Paclitaxel in the 1st or 2nd Line Treatment of Patients With Metastatic Triple Negative Breast Cancer.
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Triple Negative Breast Cancer 0 0
Metastatic Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0

Study type
Description of intervention(s) / exposure
Treatment: Drugs - AZD2281
Treatment: Drugs - Paclitaxel

Experimental: 1 - paclitaxel + AZD2281

Treatment: Drugs: AZD2281
Dose finding study to establish the appropriate dose of AZD2281

Treatment: Drugs: Paclitaxel
Intravenous infusion over 1 hour

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

Primary outcome [1] 0 0
Safety: Adverse Events (AEs), physical examination, vital signs including blood pressure (BP), pulse, electrocardiogram (ECG) and laboratory findings including clinical chemistry, hematology, urinalysis
Timepoint [1] 0 0
Physical examination/ ECG approximately monthly.Adverse Events, Vital signs, Haematology/ clinical chemistry, Urinalysis weekly throughout the study

Key inclusion criteria
- patients with histologically or cytologically diagnosed metastatic triple negative
breast cancer (Oestrogen, progesterone and HER2 negative adenocarcinoma of the breast)

- Patients must have normal organ and bone marrow function, ECOG performance status of
no more than 2

- Formalin fixed, paraffin embedded tumour sample from the primary or recurrent cancer
must be available for central testing.
Minimum age
18 Years
Maximum age
130 Years
Can healthy volunteers participate?
Key exclusion criteria
- Any chemotherapy, radiotherapy (except for palliative reasons) or investigational
product, within 2 weeks from the last dose prior to study entry (or longer period,
depending on the agent used)

- Major surgery within 4 weeks of starting the study, and must have recovered from any
effects of major surgery

- Patients requiring treatment with the following:certain antibiotic drugs, St.John's
Wort, carbamazepine, phenobarbitone, phenytoin, and certain protease inhibitors/
non-nucleoside reverse transcriptase inhibitors used as components of HIV/AIDS

- Patients with second primary cancer; except adequately treated non-melanoma skin
cancer, curatively treated in-situ cancer of the cervix, or other solid tumours
curatively treated with no evidence of disease for at least 5 years.

Study design
Purpose of the study
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 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Auchenflower
Recruitment hospital [2] 0 0
Research Site - Parkville
Recruitment hospital [3] 0 0
Research Site - Perth
Recruitment postcode(s) [1] 0 0
4066 - Auchenflower
Recruitment postcode(s) [2] 0 0
3050 - Parkville
Recruitment postcode(s) [3] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
State/province [1] 0 0
Country [2] 0 0
State/province [2] 0 0
Country [3] 0 0
State/province [3] 0 0

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry

Ethics approval
Ethics application status

Brief summary
This is the first part of a 2-part study assessing the efficacy of AZD2281 in combination
with paclitaxel in 1st or 2nd line treatment of patients with metastatic triple negative
breast cancer. This first part (Phase I) is an open-label, intra patient dose finding study
to establish the appropriate doses and schedule of paclitaxel and AZD2281 in combination, to
be used in the randomized Phase II part. The safety and tolerability of AZD2281 in
combination with paclitaxel will be explored. Approximately 10 patients per cohort from 4-5
countries will be enrolled in Phase I.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Rebecca Dent, MD
Address 0 0
Sunnybrook Health Sciences Centre, Toronto
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications