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CompletedNCT00707707Updated Mar 6, 2018

Phase I/II Study of AZD2281 Given in Combination With Paclitaxel in Metastatic Triple Negative Breast Cancer

A Phase 1 interventional study of AZD2281 and Paclitaxel in Breast Cancer, Triple Negative Breast Cancer and Metastatic Breast Cancer, sponsored by AstraZeneca. Completed at 6 sites in 4 countries. Open to female participants aged 18 Years to 130 Years. Per ClinicalTrials.gov, last updated 2018-03-06.

Sponsored by AstraZeneca · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
19
Allocation
Not applicable
Ages
18 Years to 130 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Breast Cancer
  • Triple Negative Breast Cancer
  • Metastatic Breast Cancer

Keywords

  • breast cancer
  • triple negative
  • metastatic
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 19 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 130 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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.

Exclusion criteria

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 treatment,
  • 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
19 participants (actual)

Study arms

  • Experimental
    1

    paclitaxel + AZD2281

    Drug: AZD2281 · Drug: Paclitaxel

Interventions

  • DrugAZD2281

    Dose finding study to establish the appropriate dose of AZD2281

    Also known as: Olaparib

  • DrugPaclitaxel

    Intravenous infusion over 1 hour

    Also known as: Taxol

06

What researchers measure

Primary outcomes

  1. Safety: Adverse Events (AEs), physical examination, vital signs including blood pressure (BP), pulse, electrocardiogram (ECG) and laboratory findings including clinical chemistry, hematology, urinalysis

    Time frame: Physical examination/ ECG approximately monthly.Adverse Events, Vital signs, Haematology/ clinical chemistry, Urinalysis weekly throughout the study

07

Study locations

6 sites
  • Research Site
    Auchenflower, 4066, Australia
  • Research Site
    Parkville, 3050, Australia
  • Research Site
    Perth, 6000, Australia
  • Research Site
    Wien, 1090, Austria
  • Research Site
    Leuven, 3000, Belgium
  • Research Site
    Toronto, Ontario M4N 3M5, Canada
08

References and documents

Publications

  • Dent RA, Lindeman GJ, Clemons M, Wildiers H, Chan A, McCarthy NJ, Singer CF, Lowe ES, Watkins CL, Carmichael J. Phase I trial of the oral PARP inhibitor olaparib in combination with paclitaxel for first- or second-line treatment of patients with metastatic triple-negative breast cancer. Breast Cancer Res. 2013;15(5):R88. doi: 10.1186/bcr3484. PubMed 24063698 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00707707
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Jul 1, 2008
Start date
Sep 15, 2008
Primary completion
Nov 9, 2009
Completion
Feb 19, 2018
Last update
Mar 6, 2018

Study contacts

Rebecca Dent, MD
principal investigator · Sunnybrook Health Sciences Centre, Toronto
Mark Clemons, MD
principal investigator · Princess Margaret Hospital, Toronto
Mika Sovak, MD PhD
study director · AstraZeneca

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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