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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00885755




Registration number
NCT00885755
Ethics application status
Date submitted
16/03/2009
Date registered
22/04/2009
Date last updated
29/03/2018

Titles & IDs
Public title
A Study of Herceptin (Trastuzumab)and Biomarkers in Patients With HER2-Positive Metastatic Breast Cancer
Scientific title
A Prospective Study to Evaluate Alterations in Molecular Biomarkers in HER2 Neu Positive Metastatic Breast Cancer Together With Assessment of Trastuzumab Use Beyond Progression After Initial Response to Trastuzumab-taxane Based Treatment
Secondary ID [1] 0 0
2008-004013-94
Secondary ID [2] 0 0
MO22004
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 - Standard taxane therapy
Treatment: Drugs - capecitabine [Xeloda]
Treatment: Drugs - trastuzumab [Herceptin]

Experimental: 1 -


Treatment: Drugs: Standard taxane therapy
As prescribed

Treatment: Drugs: capecitabine [Xeloda]
1000mg/m2 po bid on days 1-14 of each 3-week cycle (only in patients who have progressed)

Treatment: Drugs: trastuzumab [Herceptin]
8mg/kg iv loading dose on day 1 of first 3-week cycle, and 6mg/kg iv on day 1 of each subsequent cycle
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part I: Progression Free Survival (PFS) by Biomarker
Timepoint [1] 0 0
End of first 2 Cycles (Weeks 3 and 6), every 3 Cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months
Primary outcome [2] 0 0
Part II: Progression Free Survival (PFS) by Biomarker
Timepoint [2] 0 0
End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months
Primary outcome [3] 0 0
Part I: Time to Progression (TTP) by Biomarker
Timepoint [3] 0 0
End of first 2 Cycles (Weeks 3 and 6), every 3 Cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 weeks
Primary outcome [4] 0 0
Part II: TTP by Biomarker
Timepoint [4] 0 0
End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months
Primary outcome [5] 0 0
Part I: Percentage of Participants With a Best Overall Response (BOR) of Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progrerssive Disease (PD) by Biomarker
Timepoint [5] 0 0
End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 weeks
Primary outcome [6] 0 0
Part II: Percentage of Participants With a Best Overall Response of CR, PR, SD or PD by Biomarker
Timepoint [6] 0 0
End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months
Secondary outcome [1] 0 0
Part I: TTP in Intent to Treat (ITT) Population
Timepoint [1] 0 0
End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months
Secondary outcome [2] 0 0
Part I: PFS in ITT Population
Timepoint [2] 0 0
End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months
Secondary outcome [3] 0 0
Part II: TTP in Intent to Treat (ITT) Population
Timepoint [3] 0 0
End of first 2 Cycles (Weeks 3 and 6), every 3 Cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months
Secondary outcome [4] 0 0
Part II: PFS in ITT Population
Timepoint [4] 0 0
End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months
Secondary outcome [5] 0 0
Overall Survival in Per Protocol Population
Timepoint [5] 0 0
End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until death (up to 46 months)
Secondary outcome [6] 0 0
Overall Survival in ITT Population
Timepoint [6] 0 0
End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until death (up to 46 months)
Secondary outcome [7] 0 0
Part I and II: Percentage of Participants With a Best Overall Response of CR or PR in ITT Population
Timepoint [7] 0 0
End of first 2 Cycles (Weeks 3 and 6), every 3 Cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months
Secondary outcome [8] 0 0
Part I and II: Percentage of Participants With a Response by Best Overall Response by CR, PR, SD or PD in ITT Population
Timepoint [8] 0 0
End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months

Eligibility
Key inclusion criteria
* female patients, >=18 years of age;
* HER2-positive breast cancer;
* al least one metastatic site amenable for core biopsy;
* left ventricular ejection fraction >50%.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* prior adjuvant/neoadjuvant Herceptin within past 6 months;
* prior adjuvant taxane therapy within past 12 months;
* use of chemotherapy, immunotherapy or biological anticancer therapy within past 3 weeks;
* known bleeding diatheses.

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
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
Single group
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
13/08/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/02/2013
Sample size
Target
Accrual to date
Final
33
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital; Medical Oncology - Camperdown
Recruitment hospital [2] 0 0
Royal North Shore Hospital; Oncology - St. Leonards
Recruitment hospital [3] 0 0
Eastern Health Breast Cancer Research - East Ringwood
Recruitment hospital [4] 0 0
Border Medical Oncology; Murray Valley Private Hospital - Wodonga
Recruitment hospital [5] 0 0
Mount Medical Center - Perth
Recruitment hospital [6] 0 0
Royal Perth Hospital; Department of Medical Oncology - Perth
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2065 - St. Leonards
Recruitment postcode(s) [3] 0 0
3135 - East Ringwood
Recruitment postcode(s) [4] 0 0
3690 - Wodonga
Recruitment postcode(s) [5] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
Spain
State/province [1] 0 0
Cantabria
Country [2] 0 0
Spain
State/province [2] 0 0
Valencia
Country [3] 0 0
Sweden
State/province [3] 0 0
Stockholm
Country [4] 0 0
Sweden
State/province [4] 0 0
Uppsala
Country [5] 0 0
United Kingdom
State/province [5] 0 0
Hull
Country [6] 0 0
United Kingdom
State/province [6] 0 0
Manchester
Country [7] 0 0
United Kingdom
State/province [7] 0 0
Nottingham

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
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

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 are available at https://clinicaltrials.gov/study/NCT00885755