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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00072852




Trial ID
NCT00072852
Ethics application status
Date submitted
11/11/2003
Date registered
12/11/2003
Date last updated
15/10/2008

Titles & IDs
Public title
Irinotecan in Patients With Advanced Metastatic Breast Cancer Who Have Experienced Failure of an Anthracycline, a Taxane, and Capecitabine
Scientific title
Phase II Trial of Irinotecan in Patients With Advanced Metastatic Breast Cancer Who Have Experienced Failure of an Anthracycline, a Taxane, and Capecitabine
Secondary ID [1] 0 0
A5961023
Secondary ID [2] 0 0
CPTAPO-0047-146
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Irinotecan

Treatment: Drugs: Irinotecan


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

Outcomes
Primary outcome [1] 0 0
To evaluate the safety and efficacy of Irinotecan in refractory breast cancer.
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
- Women with diagnosis of primary adenocarcinoma of the breast

- Presence of locally advanced or metastatic disease non-amenable to surgery or
radiation therapy with curative intent

- At least one measurable lesion >20mm (or >10 mm with spiral CT scan)

- Must have received (and failed) prior treatment with an anthracycline, a taxane, and
capecitabine in the adjuvant and/or advanced disease treatment setting

- Women at least 18 years old, with performance status 0-2
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Prior treatment with another topoisomerase I inhibitor

- Current enrollment in another clinical trial

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Pfizer Investigational Site - South Brisbane
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Frankston
Recruitment postcode(s) [1] 0 0
4101 - South Brisbane
Recruitment postcode(s) [2] 0 0
3199 - Frankston
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Alaska
Country [3] 0 0
United States of America
State/province [3] 0 0
Idaho
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Kansas
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Mississippi
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
New Jersey
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
Ohio
Country [15] 0 0
United States of America
State/province [15] 0 0
Oklahoma
Country [16] 0 0
United States of America
State/province [16] 0 0
South Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Tennessee
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Washington
Country [20] 0 0
United States of America
State/province [20] 0 0
Wisconsin
Country [21] 0 0
Argentina
State/province [21] 0 0
Buenos Aires
Country [22] 0 0
Argentina
State/province [22] 0 0
Santa Fe
Country [23] 0 0
Argentina
State/province [23] 0 0
Capital Federal
Country [24] 0 0
Argentina
State/province [24] 0 0
Cordoba
Country [25] 0 0
Colombia
State/province [25] 0 0
Bogota DC
Country [26] 0 0
New Zealand
State/province [26] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this phase II, randomized, open-label clinical trial is to study 2 schedules
of single-agent Irinotecan in women with metastatic breast cancer who have experienced
failure of prior therapy with an anthracycline, a taxane, and capecitabine. Patients will
receive Irinotecan capsules either once each day for 5 days, or once a day for 14 days in 3
week cycles.
Trial website
https://clinicaltrials.gov/show/NCT00072852
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
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