A Study to Develop Predictive and Prognostic Tools for Optimizing Therapy With Bevacizumab Frontline Cancer Therapy in Participants With HER 2-Negative Aggressive Metastatic Breast Cancer
NCT ID: NCT02613208
Last Updated: 2020-02-17
Study Results
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View full resultsBasic Information
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COMPLETED
111 participants
OBSERVATIONAL
2015-12-09
2018-12-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Participants With Metastatic Breast Cancer
Participants with metastatic breast cancer receiving bevacizumab in combination with paclitaxel, will be observed for treatment responses for up to 18 months from the start of treatment.
Bevacizumab
Bevacizumab will be administered as per local clinical practice and local labeling.
Paclitaxel
Paclitaxel will be administered as per local clinical practice and local labeling.
Interventions
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Bevacizumab
Bevacizumab will be administered as per local clinical practice and local labeling.
Paclitaxel
Paclitaxel will be administered as per local clinical practice and local labeling.
Eligibility Criteria
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Inclusion Criteria
* Participant who met criteria for first-line treatment with chemotherapy plus bevacizumab (standard doses) by local, regional or national guidelines or authorities
* Participants with measurable disease (RECIST criteria v1.1) or participants with no measurable but assessable disease
* Molecular phenotype as triple negative metastatic breast cancer; and ER-positive tumors need to fulfill at least one of the two clinical criteria: metastatic relapse on adjuvant endocrine therapy or progression to at least one prior line of endocrine therapy for advanced disease; or aggressive disease criteria (at least two criteria): taxane based regimen in the (neo) adjuvant setting; metastatic relapse within 2 years from the end of chemotherapy for early breast cancer; liver metastasis; three or more organs with metastatic involvement; symptomatic visceral disease
* Eastern Cooperative Oncology Group (ECOG) 0-2
Exclusion Criteria
* Participant requiring major/minor surgery within 3 weeks prior to administration of the first dose of study treatment
* Participant has received an investigational therapy within 4 weeks prior to study entry
* Participant has known symptomatic brain metastases
* Participant with non-measurable or assessable disease: exclusive blastic bone disease; pleural, pericardial or abdominal effusion as only evidence of disease
* Participant in chronic daily treatment with corticosteroids (doses greater than \[\>\]10 milligrams per day \[mg/day\] of methylprednisolone or equivalent), except inhaled steroids
* Pregnant or breastfeeding participant
* Women of childbearing potential who are not using hormonal contraceptives or highly effective birth control during the study
* Participant has an active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
* Participant with significant renal, hematological or liver function alteration according to investigator's criteria
* Participant has serious medical risk factors involving any of the major organ systems
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Hospital Universitario Son Espases; Servicio de Oncologia
Palma de Mallorca, Balearic Islands, Spain
Hospital Provincial de Castellon; Servicio de Oncologia
Castellon, Castellon, Spain
Hospital Universitario Reina Sofia; Servicio de Oncologia
Córdoba, Cordoba, Spain
Hospital de Donostia.; Servicio de Oncología Radioterápica
San Sebastián, Guipuzcoa, Spain
Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia
A Coruña, LA Coruña, Spain
Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Oncologia
Las Palmas de Gran Canaria, LAS Palmas, Spain
Hospital de Navarra; Servicio de Oncologia
Navarra, Navarre, Spain
Hospital Quiron Barcelona; Servicio de Oncologia
Barcelona, , Spain
Hospital Universitario Virgen de las Nieves; Servicio de Oncologia
Granada, , Spain
Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
Jaén, , Spain
Complejo Asistencial Universitario de Leon; Servicio de Oncologia
León, , Spain
Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia
Lleida, , Spain
Hospital Lucus Augusti; Servicio de Oncologia
Lugo, , Spain
Hospital Universitario de la Princesa; Servicio de Oncologia
Madrid, , Spain
Centro Oncologico MD Anderson Internacional; Servicio de Oncologia
Madrid, , Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid, , Spain
Hospital Universitario La Paz; Servicio de Oncologia
Madrid, , Spain
Hospital General Universitario J.M Morales Meseguer; Servicio de Oncologia
Murcia, , Spain
Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia
Murcia, , Spain
Hospital Clinico Universitario de Salamanca; Servicio de Oncologia
Salamanca, , Spain
Hospital General de Segovia; Servicio de Oncologia
Segovia, , Spain
Hospital Universitario Virgen Macarena; Servicio de Oncologia
Seville, , Spain
Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia
Valencia, , Spain
Hospital Universitario Dr. Peset; Servicio de Oncologia
Valencia, , Spain
Complejo Hospitalario Zamora- H. Virgen de la Concha; Servicio Oncologia
Zamora, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ROC-BEV-2015-01
Identifier Type: OTHER
Identifier Source: secondary_id
ML29756
Identifier Type: -
Identifier Source: org_study_id
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