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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00191152




Registration number
NCT00191152
Ethics application status
Date submitted
12/09/2005
Date registered
19/09/2005
Date last updated
24/12/2009

Titles & IDs
Public title
A Phase III Trial For Patients With Metastatic Breast Cancer
Scientific title
Randomized Trial of Gemcitabine Plus Docetaxel vs. Docetaxel Plus Capecitabine in Metastatic Breast Cancer in 1st and 2nd
Secondary ID [1] 0 0
B9E-US-S188
Secondary ID [2] 0 0
4703
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

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

Experimental: Gemcitabine + Docetaxel -

Active Comparator: Capecitabine + Docetaxel -


Treatment: Drugs: gemcitabine
1000 mg/m2, intravenous (IV) day 1 and day 8 every 21 days until disease progression

Treatment: Drugs: docetaxel
75 mg/m2, intravenous (IV), every 21 days until disease progression

Treatment: Drugs: capecitabine
1000 mg/m2, by mouth (PO) twice a day (BID), days 1-14, every 21 days until disease progression

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

Outcomes
Primary outcome [1] 0 0
Time to Disease Progression (Initial Treatment)
Timepoint [1] 0 0
Randomization date to the earliest date of first documented disease progression date or the date of death if the participant died due to study disease (up to 82 months)
Secondary outcome [1] 0 0
Time to Disease Progression (Crossover Treatment)
Timepoint [1] 0 0
Date of first dose of crossover treatment to date of first-documented disease progression after receiving first crossover treatment or date of death due to study disease, whichever came first (up to 82 months)
Secondary outcome [2] 0 0
Progression-Free Survival (Initial Treatment)
Timepoint [2] 0 0
Date of randomization until the date of first documented progression or date of death from any cause, whichever came first (up to 82 months)
Secondary outcome [3] 0 0
Progression-Free Survival (Crossover Treatment)
Timepoint [3] 0 0
First dose date of crossover treatment to date of first-documented progression after receiving crossover treatment or date of death due to any cause, whichever came first (up to 82 months)
Secondary outcome [4] 0 0
Duration of Response (Initial Treatment)
Timepoint [4] 0 0
Date of response (CR or PR) until the first date of documented progression or death from any cause (up to 82 months)
Secondary outcome [5] 0 0
Duration of Response (Crossover Treatment)
Timepoint [5] 0 0
Date of CR or PR until first date of recurrent or progressive disease after receiving crossover treatment was objectively documented or date of date due to any cause, whichever came first (up to 82 months)
Secondary outcome [6] 0 0
Overall Survival
Timepoint [6] 0 0
Date of randomization to date of death from any cause (up to 82 months)
Secondary outcome [7] 0 0
Best Overall Response (Initial Treatment)
Timepoint [7] 0 0
Best response from start of treatment until disease progression/recurrence (up to 82 months)
Secondary outcome [8] 0 0
Best Overall Response (Crossover Treatment)
Timepoint [8] 0 0
Best response from start of treatment until disease progression/recurrence (up to 82 months)
Secondary outcome [9] 0 0
Summary of Changes in Karnofsky Performance Status (KPS) by Treatment (Initial Treatment)
Timepoint [9] 0 0
Baseline until crossover treatment began (up to 82 months)
Secondary outcome [10] 0 0
Summary of Changes in Karnofsky Performance Status (KPS) by Treatment (Crossover Treatment)
Timepoint [10] 0 0
First day of crossover treatment until end of crossover treatment at trial discontinuation (up to 82 moths)
Secondary outcome [11] 0 0
Summary of Changes in Rotterdam Symptom Checklist (RSCL) by Treatment (Initial Treatment)
Timepoint [11] 0 0
Baseline until crossover treatment began (up to 82 months)
Secondary outcome [12] 0 0
Summary of Changes in Rotterdam Symptom Checklist by Treatment (Crossover Treatment)
Timepoint [12] 0 0
First day of crossover treatment until end of crossover treatment at trial discontinuation (up to 82 months)

Eligibility
Key inclusion criteria
- Histologic or cytologic confirmation of breast cancer with locally advanced and/or
metastatic disease

- Patients may have received prior neo-adjuvant or adjuvant taxane regimen as long as it
has been greater than or equal to 6 months since completion of the regimen

- Patients may have had 0-1, but no more than one prior course of chemotherapy for
metastatic disease

- Patients must have either measurable or non-measurable (evaluable) disease

- Prior radiation therapy allowed of less than 25% of the bone marrow
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Second primary malignancy (except in situ carcinoma of the cervix or adequately
treated nonmelanomatous carcinoma of the skin or other malignancy treated at least 5
years previously with no evidence of recurrence)

- Parenchymal or leptomeningeal brain metastases

- Peripheral neuropathy greater than or equal to grade 2

- Prior treatment with gemcitabine and capecitabine will not be allowed. Prior treatment
with a taxane in the metastatic setting will not be allowed. Prior taxane therapy in
the neo-adjuvant or adjuvant setting is allowed if completion of therapy greater than
or equal to 6 months prior to enrollment.

- Active cardiac disease not controlled by therapy and/or myocardial infarction within
the preceding 6 months.

- Concomitant Herceptin is not allowed

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
Crossover
Other design features
Phase
Phase 3
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)
NSW,QLD,SA
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 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. - Waratah
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 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. - Redcliffe
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 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. - Ashford
Recruitment postcode(s) [1] 0 0
- Waratah
Recruitment postcode(s) [2] 0 0
- Redcliffe
Recruitment postcode(s) [3] 0 0
- Ashford
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Idaho
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Iowa
Country [10] 0 0
United States of America
State/province [10] 0 0
Kentucky
Country [11] 0 0
United States of America
State/province [11] 0 0
Louisiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Michigan
Country [13] 0 0
United States of America
State/province [13] 0 0
Missouri
Country [14] 0 0
United States of America
State/province [14] 0 0
Nebraska
Country [15] 0 0
United States of America
State/province [15] 0 0
New Jersey
Country [16] 0 0
United States of America
State/province [16] 0 0
New York
Country [17] 0 0
United States of America
State/province [17] 0 0
Ohio
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
South Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Tennessee
Country [21] 0 0
United States of America
State/province [21] 0 0
Texas
Country [22] 0 0
United States of America
State/province [22] 0 0
Wisconsin
Country [23] 0 0
Argentina
State/province [23] 0 0
Capital Federal
Country [24] 0 0
Argentina
State/province [24] 0 0
Mendoza
Country [25] 0 0
Argentina
State/province [25] 0 0
Rosario
Country [26] 0 0
Argentina
State/province [26] 0 0
Santa Fe
Country [27] 0 0
Brazil
State/province [27] 0 0
Porto Alegre
Country [28] 0 0
Korea, Republic of
State/province [28] 0 0
Seoul
Country [29] 0 0
Mexico
State/province [29] 0 0
Acapulco
Country [30] 0 0
Mexico
State/province [30] 0 0
Mexico City
Country [31] 0 0
Mexico
State/province [31] 0 0
Michoacan
Country [32] 0 0
Mexico
State/province [32] 0 0
Toluca
Country [33] 0 0
Puerto Rico
State/province [33] 0 0
San Juan
Country [34] 0 0
Taiwan
State/province [34] 0 0
Kaohsiung
Country [35] 0 0
Taiwan
State/province [35] 0 0
Taichung
Country [36] 0 0
Taiwan
State/province [36] 0 0
Taipei
Country [37] 0 0
Taiwan
State/province [37] 0 0
Tao-Yuan

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

Ethics approval
Ethics application status

Summary
Brief summary
This is a phase III randomized study between the docetaxel/gemcitabine and docetaxel/
capecitabine doublets, with crossover to the alternate agent. The experimental arm will
receive gemcitabine 1000 mg/m2 intravenous (IV) over 30 minutes days 1 and 8 and docetaxel 75
mg/m2 IV day 1 over 1 hour repeated every three weeks. The comparator arm will receive
docetaxel 75 mgm/m2 IV day 1 over 1 hour and oral capecitabine 1000 mg/m2 twice daily, days 1
through 14 repeated every three weeks. Patients who progress on the experimental arm, will be
treated with capecitabine as dosed on the comparator arm. Patients who progress on the
comparator arm will be treated with gemcitabine as dosed on the experimental arm.
Trial website
https://clinicaltrials.gov/show/NCT00191152
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
Other publications