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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02748213
Registration number
NCT02748213
Ethics application status
Date submitted
20/04/2016
Date registered
22/04/2016
Date last updated
22/11/2016
Titles & IDs
Public title
A Study of Herceptin (Trastuzumab) in Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Advanced and/or Metastatic Breast Cancer
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Scientific title
An Open-Label, Randomized Phase II Study of Herceptin (Trastuzumab), Taxotere (Docetaxel), and Xeloda (Capecitabine) in Combination, Versus Herceptin (Trastuzumab) Plus Taxotere (Docetaxel), in Patients With Advanced and/or Metastatic Breast Cancers That Overexpress HER2
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Secondary ID [1]
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MO16419
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast Cancer
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Condition category
Condition code
Cancer
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Breast
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Xeloda
Treatment: Drugs - Taxotere
Treatment: Drugs - Herceptin
Experimental: Herceptin + Taxotere - Participants will receive dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal.
Experimental: Herceptin + Taxotere + Xeloda - Participants will receive triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal.
Treatment: Drugs: Xeloda
Participants will receive oral Xeloda, 950 mg/m\^2 twice a day on Days 1 to 14 of each 21-day cycle.
Treatment: Drugs: Taxotere
Participants will receive Taxotere, 75 milligrams per meter-squared (mg/m\^2) in the Herceptin + Taxotere + Xeloda arm or 100 mg/m\^2 in the Herceptin + Taxotere arm, via IV infusion on Day 1 of each 21-day cycle. The lower starting dose will be used in the triple-therapy arm.
Treatment: Drugs: Herceptin
Participants will receive Herceptin, 6 milligrams per kilogram (mg/kg) via IV infusion, on Day 1 of each 21-day cycle. The first dose will be a loading dose of 8 mg/kg in Cycle 1; the dose of 6 mg/kg will be given from Cycle 2 onward.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST)
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Assessment method [1]
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Tumor response was assessed by RECIST during the study. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels. PR was defined as greater than or equal to (=) 30 percent (%) decrease in sum of longest diameter (LD) of target lesions in reference to Baseline sum LD. Response was to be confirmed =4 weeks after the initial assessment of CR or PR. The percentage of participants with a best overall response for CR or PR was reported. The exact 95% confidence interval (CI) for one-sample binomial was determined using the Pearson-Clopper method.
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Timepoint [1]
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Tumor assessments at Baseline, then every 6 weeks until Cycle 8 (cycle length of 21 days), then every 12 weeks until progressive disease and/or one year after enrollment; thereafter according to routine clinical practice (up to 66 months overall)
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Secondary outcome [1]
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Percentage of Participants With Death or Disease Progression According to RECIST
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Assessment method [1]
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Tumor response was assessed by RECIST during the study. Disease progression or progressive disease (PD) was defined as =20% increase in sum LD in reference to the smallest on-treatment sum LD, or the appearance of new lesions. The percentage of participants who died or experienced PD was reported.
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Timepoint [1]
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Tumor assessments at Baseline, then every 6 weeks until Cycle 8 (cycle length of 21 days), then every 12 weeks until progressive disease and/or one year after enrollment; thereafter according to routine clinical practice (up to 66 months overall)
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Secondary outcome [2]
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Progression-Free Survival (PFS) According to RECIST
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Assessment method [2]
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Tumor response was assessed by RECIST during the study. Disease progression or PD was defined as =20% increase in sum LD in reference to the smallest on-treatment sum LD, or the appearance of new lesions. PFS was defined as the time from start of treatment to the first event of death or PD. Participants without event at the time of analysis were censored at the latest date of last tumor assessment or last date in drug log. The median duration of PFS and corresponding 95% CI were estimated by Kaplan-Meier analysis and expressed in months.
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Timepoint [2]
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Tumor assessments at Baseline, then every 6 weeks until Cycle 8 (cycle length of 21 days), then every 12 weeks until progressive disease and/or one year after enrollment; thereafter according to routine clinical practice (up to 66 months overall)
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Secondary outcome [3]
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Percentage of Participants Who Died
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Assessment method [3]
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The percentage of participants who died from any cause was reported.
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Timepoint [3]
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Continuously during treatment (up to 66 months) and at any time after treatment discontinuation until 18 months after last participant enrolled (up to 66 months overall)
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Secondary outcome [4]
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Overall Survival (OS)
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Assessment method [4]
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OS was defined as the time from start of treatment to date of death for any reason. Participants who were alive at the time of analysis were censored at the latest date of last tumor assessment, last drug intake, or last follow-up information. The median duration of OS and corresponding 95% CI were estimated by Kaplan-Meier analysis and expressed in months.
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Timepoint [4]
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Continuously during treatment (up to 66 months) and at any time after treatment discontinuation until 18 months after last participant enrolled (up to 66 months overall)
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Secondary outcome [5]
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Duration of Response (DOR) According to RECIST
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Assessment method [5]
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Tumor response was assessed by RECIST during the study. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels. PR was defined as =30% decrease in sum LD of target lesions in reference to Baseline sum LD. Response was to be confirmed =4 weeks after the initial assessment of CR or PR. DOR was defined as the time from first assessment of CR or PR until the first occurrence of documented PD, death, or withdrawal. The median DOR was reported and expressed in months.
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Timepoint [5]
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Tumor assessments at Baseline, then every 6 weeks until Cycle 8 (cycle length of 21 days), then every 12 weeks until progressive disease and/or one year after enrollment; thereafter according to routine clinical practice (up to 66 months overall)
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Eligibility
Key inclusion criteria
* Histologically confirmed, HER2-positive advanced and/or metastatic breast cancer not amenable to curative therapy
* At least one measurable lesion according to RECIST
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Baseline left ventricular ejection fraction (LVEF) at least 50%
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Pregnant, lactating, or women of childbearing potential who are not surgically sterile or not willing to use adequate contraceptive methods
* Previous treatment with Herceptin or other anti-HER therapies, or any previous chemotherapy for advanced or metastatic disease
* Past medical history significant for any cardiac or central nervous system (CNS) disorders
* Poor hematologic, renal, or hepatic function
* Chronic corticosteroid therapy
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/2002
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/01/2008
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Sample size
Target
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Accrual to date
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Final
225
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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- Adelaide
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- Brisbane
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- Camperdown
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- Geelong
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- Melbourne
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- Perth
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Recruitment hospital [7]
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- Southport
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Recruitment postcode(s) [1]
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5011 - Adelaide
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Recruitment postcode(s) [2]
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4066 - Brisbane
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Recruitment postcode(s) [3]
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2050 - Camperdown
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Recruitment postcode(s) [4]
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3220 - Geelong
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Recruitment postcode(s) [5]
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3002 - Melbourne
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Recruitment postcode(s) [6]
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3181 - Melbourne
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Recruitment postcode(s) [7]
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6000 - Perth
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Recruitment postcode(s) [8]
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4215 - Southport
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Recruitment outside Australia
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Brazil
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Porto Alegre
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Brazil
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Rio de Janeiro
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Brazil
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Besancon
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Grenoble
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France
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Paris
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France
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Pierre Benite
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France
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Legnago
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Noale
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Lerida
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Sabadell, Barcelona
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Zaragoza
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Karlstad
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Southampton
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United Kingdom
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Weston Super Mare
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Hoffmann-La Roche
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will assess the efficacy and safety of intravenous (IV) trastuzumab (Herceptin) and IV docetaxel (Taxotere), with or without oral capecitabine (Xeloda), in women with previously untreated HER2-positive advanced and/or metastatic breast cancer.
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Trial website
https://clinicaltrials.gov/study/NCT02748213
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Trial related presentations / publications
Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2.
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Public notes
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Contacts
Principal investigator
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Address
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Hoffmann-La Roche
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02748213
Download to PDF