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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
Not applicable
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
This single arm study will evaluate alterations in molecular marker expression in HER2-positive targeted therapy, and will evaluate the effect of continued treatment with Herceptin and Xeloda beyond progression following initial Herceptin-taxane chemotherapy. Patients who develop progressive disease will receive first-line Herceptin (8mg/kg iv loading dose and 6mg/kg iv every 3 weeks) + taxane therapy. patients who develop progressive disease within 9 weeks of treatment will continue treatment with Herceptin in combination with Xeloda (1000mg/m2 po bid on days 1-14 of each 3-week cycle).Biopsies of tumor tissue will be taken for biomarker and gene profiling evaluation. The anticipated time on study treatment is until disease progression, intolerable side effects or patient choice, and the target sample size is 100 individuals.
Trial website
https://clinicaltrials.gov/study/NCT00885755
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00885755