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

• Status: Completed
• Trial end date: 2018-12-03
• Target enrollment: 0
• Participant gender: All

Summary

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

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Albumin-Bound Paclitaxel; Bevacizumab; Paclitaxel

Criteria

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