Clinical trial NCT00448591: A Study of Avastin (Bevacizumab) Plus Taxane-Based Therapy in Patients With Locally Recurrent or Metastatic Breast Cancer.
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-03-19
Enrollment: 2296
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

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.

Primary outcomes:
measure: Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) Related to Bevacizumab, Death, and AEs of Special Interest (AESIs)
timeFrame: Day 1 of Cycles 1, 2, 3, 4, 5, and 6 up to 6 months after the last bevacizumab infusion
Secondary outcomes:
measure: Percentage of Participants With Disease Progression
timeFrame: Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months
measure: Time to Progression (TTP)
timeFrame: Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months
measure: Percentage of Participants With Recorded Death
timeFrame: Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months
measure: Overall Survival
timeFrame: Baseline, Day 1 of Cycle 4, Final Visit and every 3 months during follow-up until death up to 45 months
measure: Percentage of Participants by Best Overall Response to Treatment
timeFrame: Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: La Plata
country: Argentina
city: Rosario
country: Argentina
city: Tucuman
country: Argentina
city: Adelaide
country: Australia
city: Darlinghurst
country: Australia
city: East Melbourne
country: Australia
city: Frankston
country: Australia
city: Gosford
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city: Maroochydore
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city: Perth
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city: Richmond
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city: St. Leonards
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city: Sydney
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city: Linz
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city: Ried-innkreis
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city: Steyr
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city: Villach
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city: Stavropol
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city: Tumen
country: Russian Federation
city: Tver
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city: UFA
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city: Ulyanovsk
country: Russian Federation
city: Jeddah
country: Saudi Arabia
city: Riyadh
country: Saudi Arabia
city: Riyadh
country: Saudi Arabia
city: Banska Bystrica
country: Slovakia
city: Bratislava
country: Slovakia
city: Bratislava
country: Slovakia
city: Kosice
country: Slovakia
city: Poprad
country: Slovakia
city: Presov
country: Slovakia
city: Zilina
country: Slovakia
city: Ljubljana
country: Slovenia
city: Alcorcon
country: Spain
city: Barakaldo
country: Spain
city: Barcelona
country: Spain
city: Castellon
country: Spain
city: Gijon
country: Spain
city: Las Palmas de Gran Canaria
country: Spain
city: Logroño
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Manresa
country: Spain
city: Murcia
country: Spain
city: Navarra
country: Spain
city: Orense
country: Spain
city: Palma de Mallorca
country: Spain
city: Pontevedra
country: Spain
city: Sabadell, Barcelona
country: Spain
city: Sagunto
country: Spain
city: Salamanca
country: Spain
city: San Sebastian
country: Spain
city: San Sebastian
country: Spain
city: Santiago de Compostela
country: Spain
city: Terrassa
country: Spain
city: Terrassa
country: Spain
city: Valencia
country: Spain
city: Vigo
country: Spain
city: Zamora
country: Spain
city: Göteborg
country: Sweden
city: Jonkoping
country: Sweden
city: Kalmar
country: Sweden
city: Karlstad
country: Sweden
city: Malmoe
country: Sweden
city: Stockholm
country: Sweden
city: Sundsvall
country: Sweden
city: Vaxjo
country: Sweden
city: Västerås
country: Sweden
city: Aarau
country: Switzerland
city: Baden
country: Switzerland
city: Biel
country: Switzerland
city: Genolier
country: Switzerland
city: Locarno
country: Switzerland
city: Lugano
country: Switzerland
city: Adana
country: Turkey
city: Ankara
country: Turkey
city: Gaziantep
country: Turkey
city: Istanbul
country: Turkey
city: Istanbul
country: Turkey
city: Shhiye, Ankara
country: Turkey
city: Colchester
country: United Kingdom
city: Coventry
country: United Kingdom
city: Dundee
country: United Kingdom
city: Glasgow
country: United Kingdom
city: London
country: United Kingdom
city: Peterborough
country: United Kingdom
city: Sutton
country: United Kingdom
city: Truro
country: United Kingdom
city: Westcliffe-on-sea
country: United Kingdom
city: Worthing
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Llombart-Cussac A, Pivot X, Biganzoli L, Cortes-Funes H, Pritchard KI, Pierga JY, Smith I, Thomssen C, Srock S, Sampayo M, Cortes J. A prognostic factor index for overall survival in patients receiving first-line chemotherapy for HER2-negative advanced breast cancer: an analysis of the ATHENA trial. Breast. 2014 Oct;23(5):656-62. doi: 10.1016/j.breast.2014.06.017. Epub 2014 Jul 19.
citation: Xu BH, Jiang ZF, Shen ZZ, Guan ZZ, Chen ZD, Cheng Y, Zheng H, Jiang J, Wang XJ, Tong ZS, Qin SK, Luo Y, Yao M, Wang LW, He J. Safety and efficacy of first-line bevacizumab combined with taxane therapy in Chinese patients with HER2-negative locally recurrent or metastatic breast cancer: findings from the ATHENA study. Chin Med J (Engl). 2012 Mar;125(5):764-9.