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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00437294




Registration number
NCT00437294
Ethics application status
Date submitted
16/02/2007
Date registered
19/02/2007
Date last updated
18/02/2010

Titles & IDs
Public title
Enzastaurin in Combination of Capecitabine to Treat Breast Cancer
Scientific title
A Double-Blind, Randomized, Phase 2 Trial of Capecitabine Plus Enzastaurin Versus Capecitabine Plus Placebo in Patients With Metastatic or Recurrent Breast Cancer Previously Treated With an Anthracycline and a Taxane
Secondary ID [1] 0 0
H6Q-MC-S035
Secondary ID [2] 0 0
10536
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

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

Experimental: A -

Placebo Comparator: B -


Treatment: Drugs: enzastaurin
1125 mg loading dose then 500 mg, oral, daily, 21 day cycles until progressive disease

Treatment: Drugs: placebo
oral, daily, 21 day cycles until progressive disease

Treatment: Drugs: capecitabine
1250 mg/m2, BID, days 1-14 of each 21 day cycle until progressive disease

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

Outcomes
Primary outcome [1] 0 0
Progression free survival
Timepoint [1] 0 0
baseline to measured progressive disease
Secondary outcome [1] 0 0
Pharmacology toxicity and adverse events
Timepoint [1] 0 0
every cycle
Secondary outcome [2] 0 0
Tumor markers and genes evaluated
Timepoint [2] 0 0
baseline, cycle 2, end of study
Secondary outcome [3] 0 0
Pharmacokinetics
Timepoint [3] 0 0
cycle 2

Eligibility
Key inclusion criteria
- Have been diagnosed with metastatic or recurrent breast cancer.

- Have been previously treated with both an anthracycline and a taxane.

- Have not received more than two prior chemotherapy treatment programs.

- Have stopped any antitumoral hormonal treatment before you enroll in this study.

- Have a negative pregnancy blood test if menstruating or capable of becoming pregnant.
You must use an approved birth control method during the study and for 3 months after
stopping study treatment.
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Cannot follow the study procedures (for example, you can not swallow tablets)

- Are receiving another treatment for your cancer.

- Have received another experimental drug in the last 4 weeks.

- Have had serious heart disease within last 6 months.

- Are pregnant or breast-feeding.

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
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)
ACT,NSW,VIC,WA
Recruitment hospital [1] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Garran
Recruitment hospital [2] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Caringbah
Recruitment hospital [3] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Wollongong
Recruitment hospital [4] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Frankston
Recruitment hospital [5] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Nedlands
Recruitment hospital [6] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Subiaco
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2229 - Caringbah
Recruitment postcode(s) [3] 0 0
2500 - Wollongong
Recruitment postcode(s) [4] 0 0
3199 - Frankston
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment postcode(s) [6] 0 0
6008 - Subiaco
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
Resistencia
Country [3] 0 0
Argentina
State/province [3] 0 0
Tucumain
Country [4] 0 0
France
State/province [4] 0 0
Avignon
Country [5] 0 0
France
State/province [5] 0 0
La Roche Sur Yon
Country [6] 0 0
France
State/province [6] 0 0
Lyon
Country [7] 0 0
France
State/province [7] 0 0
Paris
Country [8] 0 0
France
State/province [8] 0 0
Saint-Brieuc
Country [9] 0 0
Mexico
State/province [9] 0 0
Acapulco
Country [10] 0 0
Mexico
State/province [10] 0 0
Chihuahua
Country [11] 0 0
Mexico
State/province [11] 0 0
Cuernavaca
Country [12] 0 0
Mexico
State/province [12] 0 0
Guadalajara
Country [13] 0 0
Mexico
State/province [13] 0 0
Mexico City
Country [14] 0 0
South Africa
State/province [14] 0 0
Durban

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine whether the combination of enzastaurin and
capecitabine is more effective than the combination of placebo and capecitabine in treating
patients with breast cancer who were previously treated with an anthracycline and a taxane.
Trial website
https://clinicaltrials.gov/show/NCT00437294
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Address 0 0
Eli Lilly and Company
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

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00437294