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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


Phase 1
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer, Triple Negative Breast Cancer, Metastatic Breast Cancer

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Trial Information

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


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:

- 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

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

Safety Issue:

Yes

Principal Investigator

Rebecca Dent, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sunnybrook Health Sciences Centre, Toronto

Authority:

Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:

D0810C00011

NCT ID:

NCT00707707

Start Date:

September 2008

Completion Date:

December 2012

Related Keywords:

  • Breast Cancer
  • Triple Negative Breast Cancer
  • Metastatic Breast Cancer
  • breast cancer
  • triple negative
  • metastatic
  • Breast Neoplasms

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