Clinical trial NCT00707707: Phase I/II Study of AZD2281 Given in Combination With Paclitaxel in Metastatic Triple Negative Breast Cancer
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Cancer
Triple Negative Breast Cancer
Metastatic Breast Cancer
Keywords: breast cancer
triple negative
metastatic
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-07-01
Enrollment: 19
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Safety: Adverse Events (AEs), physical examination, vital signs including blood pressure (BP), pulse, electrocardiogram (ECG) and laboratory findings including clinical chemistry, hematology, urinalysis
timeFrame: Physical examination/ ECG approximately monthly.Adverse Events, Vital signs, Haematology/ clinical chemistry, Urinalysis weekly throughout the study
Secondary outcomes:
Other outcomes:
Locations:
city: Auchenflower
country: Australia
facility: Research Site
city: Parkville
country: Australia
facility: Research Site
city: Perth
country: Australia
facility: Research Site
city: Wien
country: Austria
facility: Research Site
city: Leuven
country: Belgium
facility: Research Site
city: Toronto
country: Canada
facility: Research Site
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre, Toronto
name: Rebecca Dent, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Princess Margaret Hospital, Toronto
name: Mark Clemons, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca
name: Mika Sovak, MD PhD
role: STUDY_DIRECTOR
References:
citation: 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.