Status:
COMPLETED
Phase I/II Study of AZD2281 Given in Combination With Paclitaxel in Metastatic Triple Negative Breast Cancer
Lead Sponsor:
AstraZeneca
Conditions:
Breast Cancer
Triple Negative Breast Cancer
Eligibility:
FEMALE
18-130 years
Phase:
PHASE1
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 f...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 15 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 19 2018
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00707707
Start Date
September 15 2008
End Date
February 19 2018
Last Update
March 6 2018
Active Locations (6)
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1
Research Site
Auchenflower, Australia, 4066
2
Research Site
Parkville, Australia, 3050
3
Research Site
Perth, Australia, 6000
4
Research Site
Vienna, Austria, 1090