Clinical trial NCT00929240: A Study of Avastin (Bevacizumab) + Xeloda (Capecitabine)as Maintenance Therapy in Patients With HER2-Negative Metastatic Breast Cancer
Official title: A Randomized Study of the Effect of Maintenance Therapy With Bevacizumab + Capecitabine Versus Bevacizumab Alone on Progression-free Survival in Patients With HER2-negative Metastatic Breast Cancer That Has Not Progressed During First-line Docetaxel Plus Bevacizumab Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2009-06-26
Enrollment: 287
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized study will compare maintenance therapy with Avastin (bevacizumab) + Xeloda (capecitabine) versus Avastin alone, in patients with HER2-negative metastatic breast cancer who have not progressed during first-line therapy with docetaxel + Avastin. Eligible patients will receive up to 6 x 3 week cycles of treatment with Avastin (15 mg/mg IV on Day 1 of each cycle) + docetaxel (75-100 mg/m2 IV on Day 1 of each cycle). Those patients who do not progress will be randomized to 3 week cycles of either a) Avastin (15 mg/kg IV on Day 1 of each cycle) + Xeloda (1000 mg/m2 po bid on Days 1-14 of each cycle) or b) Avastin alone. Study treatment will continue until disease progression, unacceptable toxicity, patient request for withdrawal or end of study, and the target sample size is 100-500 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>=18 years of age;
* HER2-negative metastatic breast cancer
* candidates for taxane-based chemotherapy;
* ECOG performance status of 0 or 1.

Exclusion Criteria:

* previous chemotherapy for metastatic breast cancer;
* prior adjuvant/neo-adjuvant chemotherapy within 6 months prior to study;
* prior radiotherapy for treatment of metastatic disease;
* chronic daily treatment with aspirin (325 mg/day) or clopidogrel(\>75mg/day).

Primary outcomes:
measure: Percentage of Participants With Disease Progression or Death (Maintenance Phase Data Cutoff October 4, 2013)
timeFrame: Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013, up to 4 years
measure: Progression Free Survival (Maintenance Phase Data Cutoff October 4, 2013)
timeFrame: Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013, up to 4 years
Secondary outcomes:
measure: Percentage of Participants With Best Overall Confirmed Objective Response of CR or PR Per RECIST 1.0 (Maintenance Phase Data Cutoff October 4, 2013)
timeFrame: Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013, up to 4 years
measure: Percentage of Participants With Clinical Benefit (CR, PR and SD) Per RECIST 1.0 (Data Cutoff October 4, 2013)
timeFrame: Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013, up to 4 years
measure: Percentage of Participants Who Died (Maintenance Phase Data Cutoff October 4, 2013)
timeFrame: Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013, up to 4 years
measure: Overall Survival (Maintenance Phase Data Cutoff October 4, 2013)
timeFrame: Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013, up to 4 years
measure: Percentage of Participants Expected to Be Alive After 1 and 2 Years on Treatment (Maintenance Phase Data Cutoff October 4, 2013)
timeFrame: Years 1 and 2
measure: Percentage Of Participants With PD or Death Due to PD (Maintenance Phase Data Cutoff October 4, 2013)
timeFrame: Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013
measure: Time To Progression (Maintenance Phase Data Cutoff October 4, 2013)
timeFrame: Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013
measure: Quality of Life Assessed As Change From Baseline in Global Health Status Using The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - 30 (EORTC QLQ - C30) (Maintenance Phase Data Cutoff October 4, 2013)
timeFrame: Baseline, Randomization and Cycles 3, 6, 9 and 12
measure: Percentage of Participants With Best Overall Confirmed Objective Response of CR or PR Per RECIST 1.0 (Initial Treatment Phase)
timeFrame: Screening and at the end of every third cycle until randomization for an average of 18 weeks
measure: Percentage of Participants With Clinical Benefit (CR, PR and SD) Per RECIST 1.0 (Initial Treatment Phase)
timeFrame: Screening and at the end of every third cycle until randomization for an average of 18 weeks
Other outcomes:
Locations:
city: Fortaleza
country: Brazil
state: CE
city: Belo Horizonte
country: Brazil
state: MG
city: Rio de Janeiro
country: Brazil
state: RJ
city: Ijui
country: Brazil
state: RS
city: Porto Alegre
country: Brazil
state: RS
city: Jau
country: Brazil
state: SP
city: Santo Andre
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
city: Hangzhou
country: China
city: Hangzhou
country: China
city: Shanghai
country: China
city: Alexandria
country: Egypt
city: Cairo
country: Egypt
city: Amiens
country: France
city: Angers
country: France
city: Besancon
country: France
city: Bobigny
country: France
city: Dijon
country: France
city: Hyeres
country: France
city: Le Coudray
country: France
city: Lille
country: France
city: Paris
country: France
city: Paris
country: France
city: Perigueux
country: France
city: Rodez
country: France
city: St Priest En Jarez
country: France
city: Strasbourg
country: France
city: Hong Kong
country: Hong Kong
city: Hong Kong
country: Hong Kong
city: Bangalore
country: India
city: Hyderabad
country: India
city: Mumbai
country: India
city: Mumbai
country: India
city: New Delhi
country: India
city: New Delhi
country: India
city: Napoli
country: Italy
state: Campania
city: Trieste
country: Italy
state: Friuli-Venezia Giulia
city: Genova
country: Italy
state: Liguria
city: Saronno
country: Italy
state: Lombardia
city: Brindisi
country: Italy
state: Puglia
city: Antella (FI)
country: Italy
state: Toscana
city: Bydgoszcz
country: Poland
city: Wroclaw
country: Poland
city: Dammam
country: Saudi Arabia
city: Jeddah
country: Saudi Arabia
city: Jeddah
country: Saudi Arabia
city: Alcoy
country: Spain
state: Alicante
city: Sabadell, Barcelona
country: Spain
state: Barcelona
city: Alcazar de S. Juan
country: Spain
state: Ciudad Real
city: Barakaldo
country: Spain
state: Vizcaya
city: Jaen
country: Spain
city: Malaga
country: Spain
city: Toledo
country: Spain
city: Valencia
country: Spain
city: Ankara
country: Turkey
city: Ankara
country: Turkey
city: Antalya
country: Turkey
city: Istanbul
country: Turkey
city: Sıhhiye, ANKARA
country: Turkey
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Gligorov J, Doval D, Bines J, Alba E, Cortes P, Pierga JY, Gupta V, Costa R, Srock S, de Ducla S, Freudensprung U, Mustacchi G. Maintenance capecitabine and bevacizumab versus bevacizumab alone after initial first-line bevacizumab and docetaxel for patients with HER2-negative metastatic breast cancer (IMELDA): a randomised, open-label, phase 3 trial. Lancet Oncol. 2014 Nov;15(12):1351-60. doi: 10.1016/S1470-2045(14)70444-9. Epub 2014 Sep 28.