Clinical trial NCT01777932: AVAREG Study: An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Breast Cancer
Official title: A Multicenter, Single-arm, Observational Study Describing the Clinical Benefits of Bevacizumab (Avastin) Treatment in Patients With Metastatic Breast Cancer (AVAREG Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-01-29
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with metastatic breast cancer initiated on treatment with Avastin in combination with paclitaxel

Brief summary: This multicenter, single-arm observational study will evaluate the clinical benefits of Avastin (bevacizumab) in combination with paclitaxel in first-line treatment in patients with metastatic breast cancer. Patients with metastatic breast cancer who have started Avastin treatment within 6 months prior to study start will also be eligible. Data will be collected from patients for up to 5 years.


Eligibility criteria: Inclusion Criteria:

* Patients with metastatic breast cancer initiated on first-line treatment with Avastin in combination with paclitaxel according to the current Hungarian summary of Product Characteristics
* Patients with metastatic breast cancer initiated within 6 months before the start of the study on treatment with Avastin according to the current Hungarian Summary of Product Characteristics

Exclusion Criteria:

Contraindications for Avastin according to the current Hungarian Summary of Product Characteristics:

* Hypersensitivity to active ingredient of Avastin or to any excipients
* Hypersensitivity to products produced in Chinese hamster cells or to other recombinant or humanized antibodies
* Pregnancy
* Untreated central nervous system metastases

Primary outcomes:
measure: Progression Free Survival
timeFrame: Approximately 5 years
Secondary outcomes:
measure: One Year Survival
timeFrame: Approximately 5 years
measure: Time to Discontinuation (TTD) of Bevacizumab Treatment
timeFrame: Approximately 5 years
measure: Participants With Hormone Receptor Status at Diagnosis
timeFrame: Baseline (Day 1)
measure: Progression Free Survival in Participants With Triple Negative Receptor Status at Study Entry
timeFrame: Approximately 5 years
measure: Participants With Tumor Stage at Diagnosis
timeFrame: Baseline (Day 1)
measure: Participants With Eastern Cooperative Oncology Group Status at Study Entry
timeFrame: Baseline (Day 1)
measure: Participants With Prior Therapy at Study Entry (Baseline)
timeFrame: Baseline (Day 1)
measure: Participants With Disease History at Study Entry (Baseline)
timeFrame: Baseline (Day 1)
measure: Participants With Type of Metastases at Study Entry (Baseline)
timeFrame: Baseline (Day 1)
measure: Participants With Proteinuria at Study Entry (Baseline)
timeFrame: Baseline (Day 1)
Other outcomes:
Locations:
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Debrecen
country: Hungary
city: Eger
country: Hungary
city: Gyor
country: Hungary
city: Gyula
country: Hungary
city: Kaposvar
country: Hungary
city: Kecskemet
country: Hungary
city: Kistarcsa
country: Hungary
city: Miskolc
country: Hungary
city: Nyíregyháza
country: Hungary
city: Pecs
country: Hungary
city: Salgótarján
country: Hungary
city: Szeged
country: Hungary
city: Szekesfehervar
country: Hungary
city: Szekszard
country: Hungary
city: Szentes
country: Hungary
city: Szolnok
country: Hungary
city: Szombathely
country: Hungary
city: Tatabánya
country: Hungary
city: Veszprem
country: Hungary
city: Zalaegerszeg
country: Hungary
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: