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)

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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

Trial documents
2

Trial contacts and locations

25

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Data sourced from clinicaltrials.gov

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