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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00448591




Registration number
NCT00448591
Ethics application status
Date submitted
16/03/2007
Date registered
19/03/2007
Date last updated
25/05/2015

Titles & IDs
Public title
A Study of Avastin (Bevacizumab) Plus Taxane-Based Therapy in Patients With Locally Recurrent or Metastatic Breast Cancer.
Scientific title
An Open-label Study to Evaluate the Safety and Effect on Disease Progression and Overall Survival of Avastin Plus Taxane-based Chemotherapy in Patients With Locally Recurrent or Metastatic Breast Cancer
Secondary ID [1] 0 0
MO19391
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 - Taxane-based chemotherapy

Experimental: 1 -


Treatment: Drugs: bevacizumab [Avastin]
10mg/kg iv on day 1 of each 3 week cycle, or 15mg/kg iv on day 1 of each 2 week cycle

Treatment: Drugs: Taxane-based chemotherapy
As prescribed

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

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) Related to Bevacizumab, Death, and AEs of Special Interest (AESIs) - Adverse events (including laboratory abnormalities) were assessed by the investigator according to the National Cancer Institute - Common Toxicity Criteria (NCI-CTC) grading systems.
Timepoint [1] 0 0
Day 1 of Cycles 1, 2, 3, 4, 5, and 6 up to 6 months after the last bevacizumab infusion
Secondary outcome [1] 0 0
Percentage of Participants With Disease Progression - Disease progression was assessed by the investigator per standard clinical practice using Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
Timepoint [1] 0 0
Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months
Secondary outcome [2] 0 0
Time to Progression (TTP) - TTP was defined as the time period from the start of first-line therapy to investigator-assessed disease progression. Tumor assessments were performed according to standard clinical practice using NCI criteria. Participants who had not progressed at the time of analysis (including those who died before progressive disease [PD]) or who were lost to follow-up were censored at the last bevacizumab administration date. Time to disease progression was determined by Kaplan-Meier estimates.
Timepoint [2] 0 0
Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months
Secondary outcome [3] 0 0
Percentage of Participants With Recorded Death
Timepoint [3] 0 0
Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months
Secondary outcome [4] 0 0
Overall Survival - Overall Survival was defined as the time from start of first-line therapy to death due to any cause. Participants for whom no death was captured in the clinical database were censored at the last date they were known to be alive. Median time to overall survival was calculated by Kaplan Meier estimates.
Timepoint [4] 0 0
Baseline, Day 1 of Cycle 4, Final Visit and every 3 months during follow-up until death up to 45 months
Secondary outcome [5] 0 0
Percentage of Participants by Best Overall Response to Treatment - Best overall response is defined as the best response shown throughout the study. Tumor assessment was performed by the investigator using standard clinical practice.
Timepoint [5] 0 0
Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months

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

- HER-2 negative adenocarcinoma of the breast, with locally recurrent or metastatic
disease; (HER-2 positive patients only if previously treated with Herceptin in the
adjuvant setting;

- candidates for chemotherapy.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- previous chemotherapy for metastatic or locally recurrent breast cancer;

- concomitant hormonal therapy for metastatic or locally recurrent disease;

- concomitant Herceptin therapy for treatment of metastatic or locally recurrent HER-2
positive disease;

- previous radiotherapy for treatment of metastatic disease;

- evidence of CNS metastases.

Study design
Purpose of the study
Treatment
Allocation to intervention
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 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)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Darlinghurst
Recruitment hospital [3] 0 0
- East Melbourne
Recruitment hospital [4] 0 0
- Frankston
Recruitment hospital [5] 0 0
- Gosford
Recruitment hospital [6] 0 0
- Lismore
Recruitment hospital [7] 0 0
- Maroochydore
Recruitment hospital [8] 0 0
- Milton
Recruitment hospital [9] 0 0
- Perth
Recruitment hospital [10] 0 0
- Richmond
Recruitment hospital [11] 0 0
- St. Leonards
Recruitment hospital [12] 0 0
- Sydney
Recruitment hospital [13] 0 0
- Wodonga
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
3002 - East Melbourne
Recruitment postcode(s) [4] 0 0
3199 - Frankston
Recruitment postcode(s) [5] 0 0
2250 - Gosford
Recruitment postcode(s) [6] 0 0
2480 - Lismore
Recruitment postcode(s) [7] 0 0
4558 - Maroochydore
Recruitment postcode(s) [8] 0 0
4064 - Milton
Recruitment postcode(s) [9] 0 0
6000 - Perth
Recruitment postcode(s) [10] 0 0
3121 - Richmond
Recruitment postcode(s) [11] 0 0
2065 - St. Leonards
Recruitment postcode(s) [12] 0 0
2031 - Sydney
Recruitment postcode(s) [13] 0 0
2060 - Sydney
Recruitment postcode(s) [14] 0 0
3690 - Wodonga
Recruitment outside Australia
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Argentina
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Buenos Aires
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Argentina
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La Plata
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Rosario
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Tucuman
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Bludesch
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Bregenz
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Dornbirn
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Austria
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Graz
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Hall in Tirol
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Austria
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Innsbruck
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Austria
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Klagenfurt
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Austria
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Krems
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Kufstein
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Leoben
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Linz
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Steyr
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Villach
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Wels
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Wiener Neustadt
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Austria
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Wien
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Austria
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Zams
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Ijui
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JAU
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Joao Pessoa
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Hang Zhou
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Lübeck
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Carpi
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Castelfranco Veneto
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Italy
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Castrovillari
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Italy
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Catania
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Italy
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Chieti
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Italy
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Como
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Lucca
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Messina
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Milano
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Napoli
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Novara
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Palermo
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Paola
Country [221] 0 0
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Pavia
Country [222] 0 0
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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 assess the safety and efficacy of a regimen of Avastin plus a
taxane, with or without additional chemotherapy, as first-line treatment in patients with
locally recurrent or metastatic breast cancer. All patients will receive Avastin (10mg/kg iv
every 2 weeks, or 15 mg/kg iv every 3 weeks) plus taxane-based chemotherapy. If taxanes are
contraindicated, alternative chemotherapy (other than anthracyclines or pegylated liposomal
doxorubicin) may be used. The anticipated time on study treatment is until disease
progression, and the target sample size is 500+ individuals.
Trial website
https://clinicaltrials.gov/show/NCT00448591
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
Other publications