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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00391092




Registration number
NCT00391092
Ethics application status
Date submitted
20/10/2006
Date registered
23/10/2006
Date last updated
28/08/2015

Titles & IDs
Public title
A Study of Avastin (Bevacizumab) in Combination With Herceptin (Trastuzumab)/Docetaxel in Patients With HER2 Positive Metastatic Breast Cancer.
Scientific title
A Randomized, Open-label Study to Compare the Effect of First-line Treatment With Avastin in Combination With Herceptin/Docetaxel and Herceptin/Docetaxel Alone on Progression-free Survival in Patients With HER2 Positive Locally Recurrent or Metastatic Breast Cancer.
Secondary ID [1] 0 0
BO20231
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 - bevacizumab [Avastin]
Treatment: Drugs - Docetaxel
Treatment: Drugs - Herceptin

Experimental: 1 -

Active Comparator: 2 -


Treatment: Drugs: bevacizumab [Avastin]
15mg/kg iv every 3 weeks

Treatment: Drugs: Docetaxel
100mg/m2 iv every 3 weeks

Treatment: Drugs: Herceptin
8mg/kg iv loading dose, followed by 6mg/kg iv every 3 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS)
Timepoint [1] 0 0
Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)
Secondary outcome [2] 0 0
Percentage of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Partial Response (PR) in Participants With Measurable Disease at Baseline
Timepoint [2] 0 0
Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)
Secondary outcome [3] 0 0
Duration of Response (DR)
Timepoint [3] 0 0
Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)
Secondary outcome [4] 0 0
Time to Treatment Failure (TTF)
Timepoint [4] 0 0
Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)
Secondary outcome [5] 0 0
Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores
Timepoint [5] 0 0
Baseline, Cycles 3, 5, 11, and post progressive disease (PD; 14 to 28 days after disease progression [up to the clinical cutoff of 30 June 2011, up to 4.75 years])
Secondary outcome [6] 0 0
Change From Baseline for FACT-G and FACT-B
Timepoint [6] 0 0
Baseline, Cycles 3, 5, 11, and post PD (14 to 28 days after disease progression [up to the clinical cutoff of 30 June 2011, up to 4.75 years])

Eligibility
Key inclusion criteria
- adult patients, >=18 years of age;

- HER2 positive breast cancer with locally recurrent or metastatic lesions;

- eligible for chemotherapy;

- baseline LVEF >=50%.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- previous chemotherapy for metastatic or locally recurrent breast cancer;

- previous radiotherapy for metastatic breast cancer (except for metastatic bone pain
relief);

- other primary tumor within last 5 years, with the exception of basal or squamous skin
cancer, or in situ cancer of the cervix;

- clinically significant cardiovascular disease;

- chronic daily treatment with aspirin (>325mg/day) or clopidogrel (>75mg/day).

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
Parallel
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
1/09/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2014
Sample size
Target
Accrual to date
Final
424
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
- Lismore
Recruitment hospital [2] 0 0
- Newcastle
Recruitment hospital [3] 0 0
- Port Macquarie
Recruitment hospital [4] 0 0
- Wahroonga
Recruitment hospital [5] 0 0
- Wollongong
Recruitment hospital [6] 0 0
- Auchenflower
Recruitment hospital [7] 0 0
- Nambour
Recruitment hospital [8] 0 0
- Fitzroy
Recruitment hospital [9] 0 0
- Geelong
Recruitment hospital [10] 0 0
- Perth
Recruitment postcode(s) [1] 0 0
2480 - Lismore
Recruitment postcode(s) [2] 0 0
2298 - Newcastle
Recruitment postcode(s) [3] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [4] 0 0
2076 - Wahroonga
Recruitment postcode(s) [5] 0 0
2500 - Wollongong
Recruitment postcode(s) [6] 0 0
4066 - Auchenflower
Recruitment postcode(s) [7] 0 0
4560 - Nambour
Recruitment postcode(s) [8] 0 0
3065 - Fitzroy
Recruitment postcode(s) [9] 0 0
3220 - Geelong
Recruitment postcode(s) [10] 0 0
6000 - Perth
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
Cordoba
Country [3] 0 0
Argentina
State/province [3] 0 0
La Plata
Country [4] 0 0
Argentina
State/province [4] 0 0
Mar del Plata
Country [5] 0 0
Argentina
State/province [5] 0 0
Mendoza
Country [6] 0 0
Argentina
State/province [6] 0 0
Salta
Country [7] 0 0
Argentina
State/province [7] 0 0
San Martin
Country [8] 0 0
Argentina
State/province [8] 0 0
Santa Fe
Country [9] 0 0
Austria
State/province [9] 0 0
Graz
Country [10] 0 0
Austria
State/province [10] 0 0
Salzburg
Country [11] 0 0
Austria
State/province [11] 0 0
Vöcklabruck
Country [12] 0 0
Austria
State/province [12] 0 0
Wien
Country [13] 0 0
Bosnia and Herzegovina
State/province [13] 0 0
Banja Luka
Country [14] 0 0
Bosnia and Herzegovina
State/province [14] 0 0
Sarajevo
Country [15] 0 0
Bosnia and Herzegovina
State/province [15] 0 0
Tuzla
Country [16] 0 0
Brazil
State/province [16] 0 0
GO
Country [17] 0 0
Brazil
State/province [17] 0 0
RS
Country [18] 0 0
Brazil
State/province [18] 0 0
SC
Country [19] 0 0
Brazil
State/province [19] 0 0
SP
Country [20] 0 0
Canada
State/province [20] 0 0
Alberta
Country [21] 0 0
Canada
State/province [21] 0 0
British Columbia
Country [22] 0 0
Canada
State/province [22] 0 0
Nova Scotia
Country [23] 0 0
Canada
State/province [23] 0 0
Ontario
Country [24] 0 0
Canada
State/province [24] 0 0
Quebec
Country [25] 0 0
Canada
State/province [25] 0 0
Saskatchewan
Country [26] 0 0
Czech Republic
State/province [26] 0 0
Praha 2
Country [27] 0 0
Czech Republic
State/province [27] 0 0
Praha 5
Country [28] 0 0
France
State/province [28] 0 0
Avignon
Country [29] 0 0
France
State/province [29] 0 0
Besancon
Country [30] 0 0
France
State/province [30] 0 0
Bordeaux
Country [31] 0 0
France
State/province [31] 0 0
Caen
Country [32] 0 0
France
State/province [32] 0 0
Clermont Ferrand
Country [33] 0 0
France
State/province [33] 0 0
Dijon
Country [34] 0 0
France
State/province [34] 0 0
Lille
Country [35] 0 0
France
State/province [35] 0 0
Montpellier
Country [36] 0 0
France
State/province [36] 0 0
Villejuif
Country [37] 0 0
Italy
State/province [37] 0 0
Emilia-Romagna
Country [38] 0 0
Italy
State/province [38] 0 0
Friuli-Venezia Giulia
Country [39] 0 0
Italy
State/province [39] 0 0
Lombardia
Country [40] 0 0
Mexico
State/province [40] 0 0
Acapulco
Country [41] 0 0
Mexico
State/province [41] 0 0
Guadalajara
Country [42] 0 0
Mexico
State/province [42] 0 0
Merida
Country [43] 0 0
Mexico
State/province [43] 0 0
Monterrey
Country [44] 0 0
Mexico
State/province [44] 0 0
Torreon
Country [45] 0 0
Romania
State/province [45] 0 0
Bucharest
Country [46] 0 0
Romania
State/province [46] 0 0
Bucuresti
Country [47] 0 0
Romania
State/province [47] 0 0
Cluj Napoca
Country [48] 0 0
Romania
State/province [48] 0 0
Cluj-Napoca
Country [49] 0 0
Romania
State/province [49] 0 0
Iasi
Country [50] 0 0
Russian Federation
State/province [50] 0 0
Kazan
Country [51] 0 0
Russian Federation
State/province [51] 0 0
Moscow
Country [52] 0 0
Russian Federation
State/province [52] 0 0
Obninsk
Country [53] 0 0
Russian Federation
State/province [53] 0 0
Ryazan
Country [54] 0 0
Russian Federation
State/province [54] 0 0
Saint-Petersburg
Country [55] 0 0
Russian Federation
State/province [55] 0 0
UFA
Country [56] 0 0
Spain
State/province [56] 0 0
Barcelona
Country [57] 0 0
Spain
State/province [57] 0 0
Cordoba
Country [58] 0 0
Spain
State/province [58] 0 0
Madrid
Country [59] 0 0
Spain
State/province [59] 0 0
Zaragoza
Country [60] 0 0
Turkey
State/province [60] 0 0
Izmir
Country [61] 0 0
Turkey
State/province [61] 0 0
Sihhiye, ANKARA
Country [62] 0 0
United Kingdom
State/province [62] 0 0
Exeter
Country [63] 0 0
United Kingdom
State/province [63] 0 0
London
Country [64] 0 0
United Kingdom
State/province [64] 0 0
Manchester
Country [65] 0 0
United Kingdom
State/province [65] 0 0
Nottingham
Country [66] 0 0
United Kingdom
State/province [66] 0 0
Preston
Country [67] 0 0
United Kingdom
State/province [67] 0 0
Rhyl
Country [68] 0 0
United Kingdom
State/province [68] 0 0
Stoke-on-Trent
Country [69] 0 0
United Kingdom
State/province [69] 0 0
Weston Super Mare
Country [70] 0 0
Uruguay
State/province [70] 0 0
Montevideo

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

Ethics approval
Ethics application status

Summary
Brief summary
This 2 arm study will compare the efficacy and safety of Avastin plus Herceptin/docetaxel,
versus Herceptin/docetaxel alone, in patients with HER2 positive locally recurrent or
metastatic breast cancer who have not received prior chemotherapy for their metastatic
disease. Patients will be randomized 1:1 to receive either Avastin (15mg/kg iv q3weeks) +
Herceptin (8mg/kg iv loading dose and 6mg/kg iv q3weeks maintenance) + docetaxel (100mg/m2 iv
q3weeks) or Herceptin + docetaxel alone. The anticipated time on study treatment is until
disease progression, and the target sample size is 100-500 individuals.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00391092
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/ct2/show/NCT00391092