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 (Argo)

Roche

Status: Completed

Conditions: Breast Cancer

Treatments: Drug: Paclitaxel; Drug: Bevacizumab

Study type: Observational

Funder types: Industry

Identifiers

NCT02613208

ROC-BEV-2015-01 (Other Identifier)

ML29756

Details and patient eligibility

About

This multicenter, observational, prospective study will identify a powerful and easy predictive/prognostic marker to use with participants under bevacizumab.

Enrollment: 111 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion 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

Exclusion criteria

• 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

Trial design

111 participants in 1 patient group

Participants With Metastatic Breast Cancer

Description:

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.

Treatment:

Drug: Bevacizumab

Drug: Paclitaxel