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
- Breast Cancer
NCT02613208 ROC-BEV-2015-01 ML29756
The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.
The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.
This multicenter, observational, prospective study will identify a powerful and easy predictive/prognostic marker to use with participants under bevacizumab.
Observational and Prospective Study to Develop Predictive and Prognostic Tools for Optimizing Therapy With Bevacizumab Frontline Cancer Therapy in Patients With Metastatic HER 2-Negative and Aggressive Disease Criteria
- 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
- 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
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