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
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Keep this study
Lead
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Participants with HER2-negative metastatic breast cancer. Mandatory to have the HER2/estrogen receptor (ER)/progesterone receptor (PR) status
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
You may not be if
Participant has received prior chemotherapy for metastatic disease
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
Clareo Health | 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
